DAQ-2024-010539

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DAQC-CI103770001-24
Site ID 10377 (B1)

MEMORANDUM

TO: FILE – BD MEDICAL

THROUGH: Chad Gilgen, Minor Source Compliance Section Manager

FROM: Susan Weisenberg, Environmental Scientist

DATE: May 28, 2024

SUBJECT: FULL COMPLIANCE EVALUATION, Minor, Salt Lake County

INSPECTION DATE: April 24, 2024

SOURCE LOCATION: 9450 South State Street
Sandy, UT 84070

DIRECTIONS: Check in with security prior to entering the building.

SOURCE CONTACTS: Stephanie Rucks, EHS Manager
801-200-0200, [e-mail]

Jon Anderson, Environmental Specialist
385-237-6340, [e-mail]

OPERATING STATUS: Operating normally.

PROCESS DESCRIPTION: BD Medical manufactures a variety of disposable medical
devices in production lines including extrusion and molding
operations. Some Volatile Organic Compound (VOC) and
Hazardous Air Pollutant (HAP) emissions are controlled with
thermal incinerators. Two 5.9 MMBtu/hr boilers and several
boilers less than 5MMBtu provide process heat and comfort
heating. Once the various medical devices come off of the
production line they are blister packed, boxed, and palletized.
The packed and palletized medical devices are then staged to
enter one of the six Ethylene Oxide (EO) sterilization chambers.
Palletized medical devices enter the chamber for phase one of
the sterilization process. The chamber is evacuated of air and
filled with nitrogen (inert gas) and steam to create an ideal
environment for the reproduction of microbes that are naturally
found in and on the medical devices and packaging. This phase
lasts for approximately three to four hours. Phase two of the
process includes the introduction of EO gas into the steam being
fed into the chamber to kill all living organisms in and outside of
the blister pack and cardboard packaging. During phase three
EO, nitrogen and steam are vacuumed from the chamber then air

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washes take place to remove off-gassing EO. The palletized
medical devices are automatically moved to aeration rooms
behind the sterilization chambers. The rooms are ventilated with
atmospheric air to aide off-gassing of EO from the medical
devices and packaging. All EO evacuated from the chambers and
aeration rooms is processed through an emission control system
made up of a concentration balancing tank, desorption tower,
and catalytic oxidizer. Off-gassed EO is destroyed by the
emission control system.

APPLICABLE REGULATIONS: Approval Order (AO) DAQE-AN103770013-22, dated
June 7, 2022
NSPS (Part 60) IIII: Standards of Performance for Stationary
Compression Ignition Internal Combustion Engines,
MACT (Part 63) O: Ethylene Oxide Emissions Standards for
Sterilization Facilities,
MACT (Part 63) ZZZZ: National Emissions Standards for
Hazardous Air Pollutants for Stationary Reciprocating Internal
Combustion Engines

SOURCE EVALUATION:

Name of Permittee: Permitted Location:

BD Medical
9450 South State Street 9450 South State Street
Sandy, UT 84070 Sandy, UT 84070

SIC Code: 3841: (Surgical & Medical Instruments & Apparatus)

Section I: GENERAL PROVISIONS

I.1 All definitions, terms, abbreviations, and references used in this AO conform to those used in the
UAC R307 and 40 CFR. Unless noted otherwise, references cited in these AO conditions refer to
those rules. [R307-101]

I.2 The limits set forth in this AO shall not be exceeded without prior approval. [R307-401]

I.3 Modifications to the equipment or processes approved by this AO that could affect the emissions
covered by this AO must be reviewed and approved. [R307-401-1]

I.4 All records referenced in this AO or in other applicable rules, which are required to be kept by
the owner/operator, shall be made available to the Director or Director's representative upon
request, and the records shall include the two-year period prior to the date of the request. Unless
otherwise specified in this AO or in other applicable state and federal rules, records shall be kept
for a minimum of two (2) years. [R307-401-8]

I.5 At all times, including periods of startup, shutdown, and malfunction, owners and operators shall,
to the extent practicable, maintain and operate any equipment approved under this AO, including
associated air pollution control equipment, in a manner consistent with good air pollution control
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practice for minimizing emissions. Determination of whether acceptable operating and
maintenance procedures are being used will be based on information available to the Director
which may include, but is not limited to, monitoring results, opacity observations, review of
operating and maintenance procedures, and inspection of the source. All maintenance performed
on equipment authorized by this AO shall be recorded. [R307-401-4]

I.6 The owner/operator shall comply with UAC R307-107. General Requirements: Breakdowns.
[R307-107]

I.7 The owner/operator shall comply with UAC R307-150 Series. Emission Inventories. [R307-150]

I.8 The owner/operator shall submit documentation of the status of construction or modification for
AAT Dry Bed System (II.A.3) to the Director within 18 months from the date of this AO. The
owner/operator shall complete construction or modification of equipment designated as "NEW"
under II.A.19 no later than May 12, 2023. The AO may become invalid if construction of the
above equipment is no commenced or is discontinued within the above timelines. To ensure
proper credit when notifying the Director, send the documentation to the Director, attn.: NSR
Section. [R307-401-18]

Status: In Compliance. Limits did not appear to be exceeded during the inspection and
records review. No additional equipment or modifications to the processes were discovered
at the time of this inspection. Records are kept electronically for a minimum of two years.
The source maintains good air pollution control practices during periods of startup,
shutdown, and malfunction. Bypass hours are logged accordingly and did not exceed the
specified hours. No breakdowns have occurred since the previous inspection. The 2023
Emissions Inventory had been submitted but had not yet been summarized in SLEIS. The
startup notification for the AAT Dry Bed System was submitted to the DAQ on March 26,
2023.

Section II: SPECIAL PROVISIONS

II.A The approved installations shall consist of the following equipment:
II.A.1 Medical Device Manufacturing Plant
II.A.2 Ethylene Oxide Sterilization Process Six (6) Sterilization Chambers Six (6) Aeration Rooms
One (1) Desorption Tower One (1) Concentration Balancing Tank One (1) Lesni Catalytic Oxidizer
MACT Applicability: Subpart O II.A.3 Advanced Air Technology (AAT) Dry Bed System (NEW) Total Capture and Control System Operating under negative pressure, treats fugitive ethylene oxide emissions from the post-sterile warehouse, the area around the chamber room, and the gas storage/dispensing area. II.A.4 Three Nexiva Catheter Zone 3 Manufacturing Lines Control: Alliance Thermal Incinerator II.A.5 Three Autoguard Catheter Manufacturing Lines Control: Alliance Thermal Incinerator
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II.A.6 One Push Button Blood Collection Manufacturing Line
Control: Alliance Thermal Incinerator
II.A.7 Alliance Thermal Incinerator
Fuel: Natural Gas or Process Off-gas
Capacity: < 5 MMBtu/hr
II.A.8 Eight Autoguard Catheter Manufacturing Lines
Control: Lesni Regenerative Thermal Oxidizer
II.A.9 Three Nexiva Manufacturing Lines
Control: Lesni Regenerative Thermal Oxidizer
II.A.10 Lesni Regenerative Thermal Oxidizer
Fuel: Natural Gas or Process Off-gas
Capacity: < 5 MMBtu/hr

II.A.11 Three Autoguard Catheter Manufacturing Lines
Control: Alliance Boxidizer Regenerative Thermal Oxidizer

II.A.12 Alliance Boxidizer Regenerative Thermal Oxidizer
Fuel: Natural Gas or Process Off-gas
Capacity: < 5 MMBtu/hr

II.A.13 Two Boilers
Fuel: Natural Gas
Capacity: 5.9 MMBtu/hr each
Control: Low-NOx Burners

II.A.14 Six Molding Operations Electric Silicone Post
Curing Ovens
Control: Electrostatic Precipitator (exhaust pre-treatment on one curing oven)
Mist Eliminator
Condensate Knockout Chamber
Coalescing Filter
HEPA Filter

II.A.15 Molding Operations Cleaning Oven
Fuel: Natural Gas
Capacity: 0.3 MMBtu/hr
Control: Thermal Oxidation

II.A.16 Nextrusion Lines
Six (6) Tower Ovens
Two (2) Post-Curing Ovens
Control: HEPA Filter
Two (2) Annealing Ovens
Two (2) Extrusion Lines
Three (3) Silicone Lines
Two (2) Cleaning Ovens
Control: Condensate Traps

II.A.17 Extrusion Lines
Ten (10) Extrusion Lines
Two (2) Material Warming Ovens
One (1) Annealing Oven
Two (2) Compounding Machines with Conveyor Ovens (1 NEW, 1 existing)
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II.A.18 Research and Development Extrusion Line One (1) Extrusion Line

II.A.19 Two Fire Suppression System Pump Engines (NEW) Fuel: Ultra-Low Sulfur Diesel (ULSD)
Rated: 286 hp*, 157 hp
NSPS Applicability: Subpart IIII MACT Applicability: Subpart ZZZZ *NEW

II.A.20 Three Emergency Power Generator Engines Fuel: ULSD
Rated: 939 hp, 1220 hp, 410 hp
NSPS Applicability: Subpart IIII MACT Applicability: Subpart ZZZZ

II.A.21 Sand Baths
Two (2) Sand Baths

Listed for informational purposes only

II.A.22 Five Storage Tanks
Diesel storage service

II.A.23 Ten Cooling Towers

II.A.24 Miscellaneous Operations
Various Quality Assurance and Research and Development Laboratories
Q-Syte Production Lines
Antimicrobial Compound Operations
Mold Press Operations
Various Forklifts and Yard Tractors

II.A.25 Various HVAC Units
Fuel: Natural Gas
Rating: < 5 MMBtu/hr

For Informational Purposes Only

II.A.26 Various Boilers
Fuel: Natural Gas
Rating: < 5 MMbtu/hr

For Informational Purposes Only

Status: In Compliance. The permitted equipment was observed as operating during the
inspection, with the following exceptions: II.A.2, currently has five (5) sterilization
chambers instead of the listed six. Item II.A.6, the One Push Button Blood Collection
Manufacturing Line has been decommissioned. Additional information regarding the
specifications for the Two Boilers (II.A.13) was submitted as a follow up data request
and as a review of the NOx Emission Controls for Natural Gas-Fired Boiler State
Rules R307-315 and R307-316, that will regulate boilers installed after May 1, 2024.
See the attached Boiler Specification documents.

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II.B Requirements and Limitations

II.B.1 Site-wide Requirement

II.B.1.a The owner/operator shall not allow visible emissions from the following emissions points to
exceed the following values:

A. Diesel-fired emergency generator engines and fire pump engines - 20% opacity

B. All other stationary point or fugitive emissions sources - 10% opacity. [R307-401-8]

Status: In Compliance. No visible emissions were observed from any stack or point.

II.B.1.a.1 Opacity observations of emissions from stationary sources shall be conducted according to 40
CFR 60, Appendix A, Method 9. [R307-401-8]

Status: In Compliance. No visible emissions were observed during the inspection. The
generators and fire pump engines were not operating. Visible emissions were assessed
according to 40 CFR 60, Appendix A, Method 9. Refer to the VEO form in the attachments
for more details.

II.B.2 VOC & HAP Requirement

II.B.2.a The owner/operator shall not emit more than the following from evaporative sources on site:

26.2 tons per rolling 12-month period of VOCs
1.77 tons per rolling 12-month period of all HAPs combined

Evaporative sources include coating of products on medical devices, cleaning, fabrication of
medical devices and associated product lines, research and development activities, laboratory
activities, etc. It excludes products of incomplete combustion from boilers, catalytic oxidizers,
incinerators, regenerative thermal oxidizers, or internal combustion engines. [R307-401-8]

II.B.2.a.1 The owner/operator shall calculate a new 12-month total quarterly, by the 20th day of January,
April, July, and October using data from the previous 12 months. If for the previous period, total
VOC and combined HAP emissions are greater than 75% of the above limits, the owner/operator
shall calculate the 12-month total monthly, by the twentieth day of each month, until total VOC
and combined HAP emissions are less than 75% of the above limits for three (3) consecutive
months. The owner/operator shall use a mass-balance method to calculate emissions from
evaporative sources. The owner/operator may use the following equations with applicable units
to comply with the mass-balance method:

VOCs = [% VOCs by Weight/100] x [Density] x [Volume Consumed]

HAP = [% HAP by Weight/100] x [Density] x [Volume Consumed]. [R307-401-8]

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II.B.2.a.2 The owner/operator shall use a mass-balance method to quantify any amount of VOCs and HAPs
controlled and treated by a thermal or catalytic oxidizer. The owner/operator shall subtract the
amount of VOCs and HAPs controlled/treated from the quantities calculated above to provide the
total emissions of VOCs and HAPs. [R307-401-8]

Status: In Compliance for II.B.2.a through II.B.2.a.2. The rolling twelve-month emission
totals from April 2023 through March 2024 for VOCs and HAPS were reported as follows:

VOCs: 15.331 tons
HAPs: 0.611 tons

See the attached Summary of Annual Emissions spreadsheet. The line stating "permitted
emissions" references PTE as per AN103770013-22. Reported emissions are calculated on a
quarterly basis. A mass balance method is used to quantify the amount of VOC and HAPs
treated by the catalytic oxidizer.

II.B.2.a.3 The owner/operator shall keep records of the following:

A. The name (as per SDS) of the VOC- and HAP-emitting material

B. The maximum percent by weight of VOCs and each HAP in each material used

C. The density of each material used

D. The volume of each VOC- and HAP-emitting material used

E. The amount of VOCs and the amount of each HAP emitted from each material

F. The amount of VOCs and the amount of each HAP reclaimed and/or controlled from
each material

G. The total amount of VOCs, the total amount of each HAP, and the total amount of all
HAPs combined emitted from all materials (in tons). [R307-401-8]

Status: In Compliance. An SDS is kept for each VOC and HAP-emitting material. Records
of each material weight, density, amount emitted, and amount controlled are maintained. A
list of each HAP with the associated chemical number was submitted. All process emissions
are routed through a thermal oxidizer system.

II.B.2.b The owner/operator shall comply with R307-304, Solvent Cleaning. [R307-304]

Status: Not applicable as the facility is subject to R307-350 for Miscellaneous Metal Parts
and Products Coatings, and R307-353 for Plastic Parts Coatings.

II.B.3 Ethylene Oxide Sterilization Condition

II.B.3.a The owner/operator shall not consume more than 213,300 pounds of ethylene oxide per rolling
12-month period. [R307-401-8]

Status: In Compliance. See below condition status.

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II.B.3.a.1 The owner/operator shall:

A. Determine consumption based on inventory and purchase records.

B. Use consumption records to calculate a new rolling 12-month total by the 20th
day of each month using data from the previous 12 months. [R307-401-8]

Status: In Compliance. The rolling 12-month consumption total for ethylene oxide from
April 2023 through the end of March 2024 was reported as 139,636 pounds. The
consumption total is based on daily inventory and purchase records. New monthly totals
are calculated by the 20th day of each month. See the attached Ethylene Oxide Total Usage
(lbs) record.

II.B.4 Catalytic Oxidation Requirement

II.B.4.a The owner/operator shall route emissions from each sterilization chamber to the concentration-
balancing tank, prior to being discharged to and processed by the desorption tower. [R307-401-8]

Status: In Compliance. This is the emissions pathway for the sterilization chamber.

II.B.4.b The owner/operator shall route emissions from the concentration-balancing tank desorption
tower, and the aeration rooms to the catalytic oxidizer before being discharged to the atmosphere.
[R307-401-8]

Status: In Compliance. This is the emissions pathway for the concentration-balancing tank
desorption tower.

II.B.4.c The owner/operator shall maintain a temperature at or above 140 degrees Celsius in the catalytic
oxidizer catalyst bed while any of the associated process lines are operating. [40 CFR 63
Subpart O, R307-401-8]

Status: In Compliance. See the below condition status.

II.B.4.c.1 The owner/operator shall install, calibrate, maintain, and operate a device to monitor the
operating temperature of the catalytic oxidizer in accordance with 40 CFR 63 Subpart O. The
owner/operator shall maintain records as specified in 40 CFR 63 Subpart O. [40 CFR 60
Subpart O]

Status: In Compliance. Records review indicated the catalytic oxidizer has not fallen below
the 140-degree Celsius threshold. The catalytic oxidizer has an auto shut down that is
activated if the temperature falls below 140 degrees Celsius. The computer tracks the
temperature, with redundancies built in to ensure the correct temperature and monitor for
leaks. Electronic temperature checks are recorded every 10 minutes. Western States
calibrates the monitoring device every 7 to 12 months. See the attached calibration record
for this time period.

II.B.5 Dry Bed System

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II.B.5.a The owner/operator shall install an AAT Dry Bed System to control non-process emissions
related to ethylene oxide use. [R307-401-8]

Status: In Compliance. The Dry Bed System is used to control non-process emissions
related to ethylene oxide use.

II.B.5.b The owner/operator shall replace the media within the dry bed system no less frequently than
every 5 years. A performance stack test shall be performed within 180 days after media
replacement. The owner/operator shall maintain proof of replacements for the lifetime of the
system. [R307-401-8]

Status: In Compliance. The Dry Bed System uses a media that will be replaced no less
frequently than every 5 years. The startup for this system occurred in January of 2023. The
facility managers are aware of this condition and are tracking the replacement frequency
of the media. A successful stack test for this system was conducted on April 5, 2023.

II.B.5.c The owner/operator shall not emit more than the following rate and concentration from the
combined dry bed exhaust:

Pollutant lb/hr ppm
Ethylene Oxide 0.02 0.05

[R307-401-8]

Status: In Compliance. An initial stack test for EO for the Dry Bed System occurred on
January 18, 2023. This first test exceeded the EO limits. See DAQC-369-23. A second
successful test was conducted on April 5, 2023. The resulting EO measurement was tested
at 0.01461 lb/hr and 0.0449 ppm. See DAQC-554-23 for additional information.

II.B.5.d To demonstrate compliance with the emission limitation above, the owner/operator shall conduct
emission testing as outlined below. [R307-401-8]

II.B.5.d.1 Initial Test
The owner/operator shall conduct an initial emissions test within 180 days after startup of the dry
bed system. [R307-165-2]

II.B.5.d.2 Notification
At least 30 days prior to conducting an emission test, the owner/operator shall submit a source
test protocol to the Director. The source test protocol shall include the items contained in
R307-165-3. If directed by the Director, the owner/operator shall attend a pretest conference.
[R307-165-3, R307-401-8]

II.B.5.d.3 Testing & Test Conditions
The owner/operator shall conduct testing according to the approved source test protocol and
according to the test conditions contained in R307-165-4. [R307-165-4, R307-401-8]

II.B.5.d.4 Reporting
No later than 60 days after completing the emissions test, the owner/operator shall submit a
written report of the results from the testing to the Director. The report shall include validated
results and supporting information. [R307-165-5, R307-401-8]

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II.B.5.d.5 Possible Rejection of Test Results
The Director may reject testing results if the test did not follow the approved source test protocol
or for a reason specified in R307-165-6. [R307-165-6, R307-401-8]

II.B.5.e Test Methods
When performing the dry bed emission testing, the owner/operator shall use EPA Method 18,
EPA Method 320, or other EPA-approved testing method as approved by the Director in the test
protocol. [R307-401-8]

II.B.5.e.1 Standard Conditions

A. Temperature - 68 degrees Fahrenheit (293 K)

B. Pressure - 29.92 in Hg (101.3 kPa)

C. Averaging Time - As specified in the applicable test method

[40 CFR 60 Subpart A, 40 CFR 63 Subpart A, R307-401-8]

Status: In Compliance for the above stack testing requirements. All protocol and operating
procedures were followed for the successful stack test dated April 5, 2023. See
DAQC-554-23 for more information.

II.B.6 Alliance Thermal Incinerator Requirement

II.B.6.a The owner/operator shall route all non-fugitive emissions from the process lines on the north side
of the plant to the Alliance Thermal Incinerator before being discharged to the atmosphere,
except when routed to the Boxidizer Thermal incinerator or during periods of thermal incinerator
bypass. The north side of the plant includes but is not limited to, one (1) Push Button Blood
Collection line, three (3) Nexiva Zone 3 lines, and three (3) Autoguard manufacturing lines
(including spring winders). [R307-401-8]

Status: In Compliance. This is the emissions pathway for the north side process lines.

II.B.6.b The owner/operator shall not bypass the Alliance thermal incinerator for more than 96 hours per
rolling 12-month period. [R307-401-8]

Status: In Compliance. See the below condition status.

II.B.6.b.1 The owner/operator shall:

A. Determine hours of bypass by monitoring and maintaining an operating log.

B. Record of date, time, and reason the Alliance thermal incinerator was bypassed.

C. Use the hours of bypass to calculate a new rolling 12-month total by the
20th day of each month using data from the previous 12 months. [R307-401-8]

Status: In Compliance. The total bypass hours of this system was reported as 23.7 hours
for the rolling 12-month period. An operations log is maintained which includes the date,
time, and reason the Alliance Thermal Incinerator was bypassed.
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II.B.6.c The owner/operator shall maintain a temperature at or above 1,400 degrees Fahrenheit in the
Alliance thermal incinerator when any associated process lines are running. [R307-401-8]

Status: In Compliance. See the below condition status.

II.B.6.c.1 The owner/operator shall:

A. Install, calibrate, maintain, and operate a device to monitor the
operating temperature of the thermal incinerator.

B. Place the monitoring device in a readily accessible location

C. Record the temperature of the thermal incinerator daily when any
associated process lines are operating. [R307-401-8]

Status: In Compliance. The thermometer is readily accessible near the incinerator. The
temperature reading was just under 1,600 degrees Fahrenheit at the time of inspection.
Calibration is completed according to manufacturer's recommendations. The source
indicated that an alarm sounds and the system shuts down if the temperature drops below
1,400 degrees Fahrenheit.

II.B.7 Regenerative Thermal Oxidizer (Lesni and Boxidizer) Requirement

II.B.7.a The owner/operator shall route all non-fugitive emissions from the process lines on the south
side of the plant to the Lesni regenerative oxidizer before being discharged to the atmosphere,
except during periods of regenerative oxidizer bypass. This includes, but is not limited to, eight
(8) Autoguard lines (including spring winders), and three (3) Nexiva manufacturing lines.
[R307-401-8]

Status: In Compliance. This is the emissions pathway for the south process lines.

II.B.7.b The owner/operator shall route all non-fugitive emissions from the three (3) Autoguard Lines
(including spring winders) to the Alliance Boxidizer before being discharged to the atmosphere,
except during periods of regenerative thermal incinerator bypass. [R307-401-8]

Status: In Compliance. This is the emissions pathway for the three Autoguard lines.

II.B.7.c The owner/operator shall not bypass either regenerative thermal incinerator for more than 96
hours each per rolling 12-month period. [R307-401-8]

Status: In Compliance. See the below condition status.

II.B.7.c.1 The owner/operator shall:

A. Determine hours of bypass by monitoring and maintaining an operators log.

B. Record of date, time, and reason the regenerative thermal incinerator(s)
was/were bypassed.

C. Use the hours of bypass to calculate a new rolling 12-month total by the 20th
day of each month using data from the previous 12 months for each
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regenerative thermal incinerator. [R307-401-8]

Status: In Compliance. The total bypass hours for the two Regenerative Thermal Oxidizer
(RTO) for the rolling 12-month period of April 2023 through the end of March 2024 were
reported as follows:

26.7 hours for the Alliance Boxidizer
21.1 hours for the Lesni

Operation logs are maintained for both systems which include the date, time, and reason
for bypass. Calculations are made according to this condition. See the attached
spreadsheet.

II.B.7.d The owner/operator shall maintain the following temperatures in the regenerative thermal
incinerators when any associated process lines are running:

A. A temperature at or above 1,400 degrees Fahrenheit in the Alliance Boxidizer
regenerative thermal oxidizer

B. A temperature at or above 700 degrees Celsius in the Lesni regenerative thermal
oxidizer. [R307-401-8]

Status: In Compliance. See the below condition status.

II.B.7.d.1 The owner/operator shall:

A. Install, calibrate, maintain, and operate a device to monitor the operating
temperature of each regenerative thermal incinerator.

B. Place the monitoring devices in a readily accessible location

C. Record the temperatures of each regenerative thermal incinerator daily when any
associated process lines are operating. [R307-401-8]

Status: In Compliance. The thermometers were readily accessible near the incinerators.
The temperature reading was 1,612 degrees Fahrenheit for the Alliance Boxidizer and 700
degrees Celsius for the Lesni RTO at the time of inspection. Calibration is completed
according to manufacturer's recommendations. See the attached Western States
calibration records. Temperature records were reviewed during the site visit. A snap shoot
of the temperature read out was submitted with the requested site records.

II.B.8 Molding Operations Electric Silicone Post-Curing Ovens Requirement

II.B.8.a The owner/operator shall route all non-fugitive emissions from the curing oven to the Filter
Trains before being discharged to the atmosphere. The filter trains include an electrostatic
precipitator (one train only), a mist eliminator, a condensate blowout chamber, a coalescing
filter, and finally a HEPA filter. [R307-401-8]

Status: In Compliance. This is the emissions pathway for the curing oven.

II.B.9 Molding Operations Cleaning Oven Requirement
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II.B.9.a The owner/operator shall route all non-fugitive emissions from the Molding Operations Cleaning
Oven through the oven's thermal oxidizer before being discharged to the atmosphere.
[R307-401-8]

Status: In Compliance. This is the emissions pathway for the Molding Operations Cleaning
Oven.

II.B.9.b The owner/operator shall maintain a temperature at or above 1,400 degrees Fahrenheit in the
thermal incinerator attached to the Molding Operations Cleaning Oven when the oven is
operating. [R307-401-8]

Status: In Compliance. The Molding Operations Cleaning Oven is maintained at or above
the required temperature. An alarm system is in place to stop the process in the event of
the temperature falling below the proscribed limit.

II.B.9.b.1 The owner/operator shall: A. Install, calibrate, maintain, and operate a device to monitor the operating temperature of the thermal incinerator. B. Place the monitoring device in a readily accessible location C. Record the temperature of the thermal incinerator daily when cleaning oven is in use. [R307-401-8] Status: In Compliance. The Molding Operations Cleaning Oven has an installed monitoring device that is easily accessible. The temperatures are recorded at least daily. The monitor is calibrated as required by Western States.

II.B.10 Nextrusion Lines and Extrusion Lines Requirement

II.B.10.a The owner/operator shall install a HEPA filter on the Nextrusion Line post-curing ovens.
[R307-401-8]

Status: In Compliance. HEPA filters have been installed as required.

II.B.10.a.1 The owner/operator shall replace the filters according to system design/manufacturer
recommendations. [R307-401-4, R307-401-8]

Status: In Compliance. The source indicated that HEPA filters are installed for this
process and changed according to manufacturer recommendations.

II.B.10.b The owner/operator shall equip the cleaning ovens with condensate traps for particulate control.
[R307-401-8]

Status: In Compliance. Condensate traps have been installed.

II.B.10.b.1 The owner/operator shall clean and maintain condensate traps in accordance with the
manufacturer recommendations. [R307-401-8]

Status: In Compliance. The cleaning ovens are equipped with condensate traps. The
condensate traps are cleaned according to a preventative maintenance schedule.
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II.B.11 Emergency Engines

II.B.11.a The owner/operator shall not operate each emergency engine or fire pump engine on site for
more than 100 hours per rolling 12-month period during non-emergency situations. There is no
time limit on the use of the engines during emergencies. [40 CFR 63 Subpart ZZZZ,
R307-401-8]

Status: In Compliance. None of the installed engines operated for over 100 hours for non-
emergency situations.

II.B.11.a.1 To determine compliance with a rolling 12-month total, the owner/operator shall calculate a new
12-month total by the 20th day of each month using data from the previous 12 months. Records
documenting the operation of each emergency engine shall be kept in a log and shall include the
following:

A. The date the emergency engine was used

B. The duration of operation in hours

C. The reason for the emergency engine usage. [40 CFR 63 Subpart ZZZZ, R307-401-8]

Status: In Compliance. The rolling 12-month operating hours from April 2023 through
March 2024 for the emergency generators (II.A.20) and the north emergency fire pump
engine (II.A.19) were below the 100-hour threshold for non-emergency usage. Records are
maintained in a digital log for all operation hours. The records include the duration and
reason for usage is recorded for each engine. The North Side backup generator was
recorded at 69.7 hours. The West Side backup generator was recorded at 25.5 hours. The
South Side EO Operation backup generator was recorded at 22.2 hours and the Fire Pump
engine backup was recorded at 31.6 hours. See the attached Generator Run Hours
spreadsheet.

II.B.11.a.2 To determine the duration of operation, the owner/operator shall install a non-resettable hour
meter for each emergency engine and fire pump engine on site. [40 CFR 63 Subpart ZZZZ,
R307-401-8]

Status: In Compliance. Non-resettable hour meters are present on each emergency engine
and both fire pump engines. The meters were viewed during the inspection.

II.B.11.b The owner/operator shall only use diesel fuel (e.g. fuel oil #1, #2, or diesel fuel oil additives) in
each emergency engine. [R307-401-8]

Status: In Compliance.

II.B.11.b.1 The owner/operator shall only combust diesel fuel that meets the definition of ultra-low sulfur
diesel (ULSD), which has a sulfur content of 15 ppm or less. [R307-401-8]

Status: In Compliance.

15
II.B.11.b.2 To demonstrate compliance with the ULSD fuel requirement, the owner/operator shall maintain
records of diesel fuel purchase invoices or obtain certification of sulfur content from the diesel
fuel supplier. The diesel fuel purchase invoices shall indicate that the diesel fuel meets the
ULSD requirements. [R307-401-8]

Status: In Compliance. Ultra-low sulfur diesel is utilized in each engine. This was
determined from a fuel purchase invoice provided by the fuel supplier.

Section III: APPLICABLE FEDERAL REQUIREMENTS

In addition to the requirements of this AO, all applicable provisions of the following federal programs
have been found to apply to this installation. This AO in no way releases the owner or operator from any
liability for compliance with all other applicable federal, state, and local regulations including UAC
R307.

NSPS (Part 60) IIII: Standards of Performance for Stationary Compression Ignition Internal Combustion
Engines

Status: In Compliance. This applies to the North 157 hp diesel-fired Fire Suppression System Pump
engine, West 410 hp emergency power engine, and the south 286 hp Fire Pump engine. The engines are
equipped with non-resettable hour meters. No engine was operated over the 100-hour limit.
Maintenance is performed by contractors and is recorded as required.

MACT (Part 63) O: Ethylene Oxide Emissions Standards for Sterilization Facilities

Status: In Compliance. The Lesni Abatement System was tested for compliance with Subpart O
Standards on January 19, 2023. The DAQ received a copy of the test report on March 17, 2023. A stack
testing review memo accepting the results as compliant was issued on March 24, 2023 (See the attached
memo DAQC-361-23). BD Medical operates a catalytic oxidation system that controls emissions from all
equipment in the sterilization process. BD Medical operates an extensive Ethylene Oxide monitoring
system. Monitors and alarms are installed throughout the facility and employees working in the
prep/sterilization/aeration processes wear personal detection monitors. All equipment associated with
the handling of Ethylene Oxide is equipped with sensors and alarms that report to the control room. BD
Medical implements an extensive leak detection and repair program for all pumps, piping, fittings,
valves, and flanges in the Ethylene Oxide. BD Medical conducts daily instrument checks for leak
detection of Ethylene Oxide. Prior to storage of Ethylene Oxide in DOT-approved drums, BD Medical
conducts a Nitrogen purge of the drums, followed by a soap solution test to identify any potential leaks.

MACT (Part 63) ZZZZ: National Emissions Standards for Hazardous Air Pollutants for Stationary
Reciprocating Internal Combustion Engines

Status: In Compliance. This applies to the Fire Suppression Pump Engines and the Emergency Power
Engines listed in II.A.19 and II.A.20. The engines are equipped with non-resettable hour meters. No
engine was operated over the 100-hour limit. Maintenance is performed by contractors and is recorded
as required.

AREA SOURCE RULES EVALUATION:

The following Area Source Rules were evaluated during this inspection:

16
Solvent Cleaning [R307-304]

Status: Exempt due to the applicability of R307-350 and R307-353.

Miscellaneous Metal Parts and Products Coatings [R307-350]

Status: In Compliance. This rule applies to metal parts and products coating operations in Salt Lake
County. As part of the catheter manufacturing process, VOC containing materials are applied to
metal parts as a coating operation. VOC containing materials are stored in closed containers when
not in use, and spills are minimized. Emissions from these processes are routed to one of the three
oxidizers and capture efficiency is greater than 90%.

Plastic Parts Coatings [R307-353]

Status: In Compliance. This rule applies to plastic parts coating operations in Salt Lake County. As
part of the catheter manufacturing process, VOC containing materials are applied to plastic parts
as a coating operation. VOC containing materials are stored in closed containers when not in use,
and spills are minimized. Emissions from these processes are routed to one of the three oxidizers
and capture efficiency is greater than 90%.

EMISSION INVENTORY:

Listed before are the Actual Emissions Inventory provided from BD Medical. A comparison of the
estimated total potential emissions (PTE) on AO: DAQE-AN103770013-22, dated June 7, 2022, is
provided. PTE are supplied for supplemental purposes only.

Criteria Pollutant PTE tons/yr Actuals tons/yr
CO2 Equivalent 20285.00
Carbon Monoxide 13.23
Nitrogen Oxides 16.76
Particulate Matter - PM10 5.71
Particulate Matter - PM2.5 6.14
Sulfur Dioxide 0.76
Volatile Organic Compounds 31.34

Hazardous Air Pollutant PTE lbs/yr Actuals lbs/yr
2,2,4-Trimethylpentane (CAS #540841) 542
Diethanolamine (CAS #111422) 462
Ethylene Glycol (CAS #107211) 409
Ethylene Oxide (CAS #75218) 229
Formaldehyde (CAS #50000) 307
Generic HAPs (CAS #GHAPS) 1056
Hexane (CAS #110543) 592
Methanol (CAS #67561) 655
Styrene (CAS #100425) 10

17
PREVIOUS ENFORCEMENT
ACTIONS: A stack test performed on January 18, 2023, was found to have
exceeded the limits of Condition II.b.5.c (See DAQC-369-23 for
more information). The stack test was successfully performed
again on April 5, 2023, to demonstrate compliance with this
Condition (See DAQC-554-23). An Early Settlement Agreement
was issued with a $2,160 penalty on May 26, 2023,
DAQC-550-23, to resolve the issue of non-compliance.

COMPLIANCE STATUS &
RECOMMENDATIONS: This facility should be considered to be in compliance with the
AO AN103770013-22, dated June 7, 2022, and the Federal
Subparts for NSPS IIII, MACT O, and MACT ZZZZ at the time
of this inspection.

HPV STATUS: Not Applicable.

RECOMMENDATION FOR
NEXT INSPECTION: Inspect as usual maintaining the same targeting frequency.

NSR RECOMMENDATIONS: Recommend that future AO modifications remove references to
R307-304 applicability in Condition II.B.2.b and change it to
reference conditions R307-350 and R307-353.

ATTACHMENTS: VEO, correspondence regarding boiler specifications, Summary
of Emissions tables including VOC and HAPs totals, generator
operation hours, EO usage tables, calibration reports, snapshot of
temperature logs, the original 2005 boiler environmental
consultant submission, 2023 Lensi Catalytic Oxidizer Subpart O
stack test memo, and Emissions Inventory Summary.
Susan Weisenberg <[e-mail]>
RE: BD Sandy UDAQ 24 April 2024 Inspection Records
1 message
Stephanie Rucks <[e-mail]>Tue, Apr 30, 2024 at 5:33 PM
To: Susan Weisenberg <[e-mail]>
Cc: Brenda Fogg <[e-mail]>, Bob Partner <[e-mail]>
Hello Susan –

Good afternoon. Attached please find the following records as requested from our inspection on Wednesday, April 24.
II.A.13 5.9 MMBtu/hr Sterilization Boilers
The capacity for these boilers were calculated as follows from the attached documents (II.A.13 - Sterilization Boiler
- Derating Factor for Altitude from ECI Inc. September 2005 & 6B90242 - II.A.13 Boiler – Drawing)
177 BHP/200HP = 0.885 (for the derated horsepower at 4500 elevation)
6,695 MBH x 0.885 = 5,925.075 MMBtu/hr capacity
04E-7058 Emissions Calculations for April 2023 – March 2024
II.B.2.a – VOC and HAP rolling 12-month, quarterly emissions summary
3 EO Use and Generator Run for April 2023 – March 2024
II.B.3.a – monthly tracking of ethylene oxide consumption per rolling 12-month period
II.B.6.b – 96 hour bypass trackers for the Alliance Thermal Incinerator, Lesni RTO and Boxidizer RTO
II.B.11.a – Emergency Engine 100 hour tracker for non-emergencies for II.A.19 & II.A.20
Snapshots of temperature tracking on the Oxidizers & Molding Cleaning Oven
Calibration examples for the thermometers:
II.B.9 Molding Operations Cleaning Oven Calibration Certificate
II.B.4 Sterilization Catalytic Oxidizer, Internal calibration certificate & Vendor certificate
II.B.6.c.1 Alliance RTO Calibration Certificate

Please let me know if you have any questions or need anything else.

Warm regards,
Stephanie
Stephanie Rucks
Site EHS Manager
Environmental Health & Safety
[e-mail]
9450 South State Street
Sandy, Utah, 84070US
c: 801.200.0200
bd.com

BD Restricted
5/8/24, 11:47 AM State of Utah Mail - RE: BD Sandy UDAQ 24 April 2024 Inspection Records
https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1797804559056808176%7Cmsg-f:1797804559056808176&…1/8
From: Stephanie Rucks
Sent: Monday, April 29, 2024 6:01 PM
To: 'Susan Weisenberg' <[e-mail]>
Cc: Brenda Fogg <[e-mail]>
Subject: BD Sandy UDAQ Inspection Update

Hello Susan,

Good evening. I have one more record from my Metrology department for a calibrated probe that I’m getting this evening and will
send all of the requested information over to you by the end of the day tomorrow, April 30.

Thank you,
Stephanie
Stephanie Rucks
Site EHS Manager
Environmental Health & Safety
[e-mail]
9450 South State StreetSandy, Utah, 84070
US
c: 801.200.0200
bd.com

From: Stephanie Rucks
Sent: Wednesday, April 24, 2024 5:44 PM
To: Susan Weisenberg <[e-mail]>
Cc: Brenda Fogg <[e-mail]>
Subject: RE: EPA scheduled Eto inspection for April 24, 2024

Hello Susan,

Good evening. I just realized I did not confirm the date you need the records from us. I think you mentioned 5 days? Work days?
If you could please send me the date that would be great. Thank you.

Nice to meet you today.
Warm regards,
Stephanie
5/8/24, 11:47 AM State of Utah Mail - RE: BD Sandy UDAQ 24 April 2024 Inspection Records
https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1797804559056808176%7Cmsg-f:1797804559056808176&…2/8
This Message Is From an External Sender
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Stephanie Rucks
Site EHS Manager
Environmental Health & Safety
[e-mail]
9450 South State Street
Sandy, Utah, 84070
US
c: 801.200.0200
bd.com

From: Susan Weisenberg <[e-mail]>
Sent: Tuesday, April 23, 2024 2:33 PM
To: Stephanie Rucks <[e-mail]>
Cc: Chad Gilgen <[e-mail]>; Connor Kijowski <[e-mail]>; [e-mail]
Subject: Re: EPA scheduled Eto inspection for April 24, 2024

EXTERNAL EMAIL - Use caution opening attachments and links.
Hello Stephanie, I wanted to give you a heads up that we will be joined by an additional DAQ inspector, Conner Kijowski, for a total of 4 individuals for tomorrow's site visit. We will meet as described by your previous email at the south
ZjQcmQRYFpfptBannerStart
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Hello Stephanie, I wanted to give you a heads up that we will be joined by an additional DAQ inspector, Conner Kijowski, for a
total of 4 individuals for tomorrow's site visit. We will meet as described by your previous email at the south side entrance.
Thanks, let me know if you have any comments or questions.
Susan Weisenberg,
Environmental Scientist
Office: 385-306-6512

5/8/24, 11:47 AM State of Utah Mail - RE: BD Sandy UDAQ 24 April 2024 Inspection Records
https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1797804559056808176%7Cmsg-f:1797804559056808176&…3/8
On Mon, Apr 15, 2024 at 1:37 PM Stephanie Rucks <[e-mail]> wrote:
Good afternoon. I’ll have you go to the South entrance then, see the map below. The visitor parking is closest to the
highlighted entrance. I’ll get you signed in at the Security desk and then we can go to the conference room for a quick debrief
and set any items down that you do not want to carry and then go walk the plant. Thank you.

Warm regards,
Stephanie

BD Restricted
From: Susan Weisenberg <[e-mail]>
Sent: Monday, April 15, 2024 10:34 AM
To: Stephanie Rucks <[e-mail]>
Cc: Chad Gilgen <[e-mail]>
Subject: Re: EPA scheduled Eto inspection for April 24, 2024

EXTERNAL EMAIL - Use caution opening attachments and links.
I have not been to your facility before. We will be happy to meet you at whichever entrance is more convenient for your staff. Thanks! Susan Weisenberg, Environmental Scientist Office: 385-306-6512 On Mon, Apr 15, 2024 at 10: 19 AM Stephanie
ZjQcmQRYFpfptBannerStart
5/8/24, 11:47 AM State of Utah Mail - RE: BD Sandy UDAQ 24 April 2024 Inspection Records
https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1797804559056808176%7Cmsg-f:1797804559056808176&…4/8
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I have not been to your facility before. We will be happy to meet you at whichever entrance is more convenient for your staff.
Thanks!
Susan Weisenberg,
Environmental Scientist
Office: 385-306-6512

On Mon, Apr 15, 2024 at 10:19 AM Stephanie Rucks <[e-mail]> wrote:
Hello –

Thank you for the details. Have you been out to the plant before? We have two entrances, East and South, and I can wait
in the entrance that you prefer. Just let me know.

Thank you,
Stephanie

BD Restricted
From: Susan Weisenberg <[e-mail]>
Sent: Monday, April 15, 2024 10:11 AM
To: Stephanie Rucks <[e-mail]>
Cc: Chad Gilgen <[e-mail]>
Subject: Re: EPA scheduled Eto inspection for April 24, 2024

EXTERNAL EMAIL - Use caution opening attachments and links.
Hello, I know that we will have a minimum of three, which will include myself, the EPA inspector, and my Section Manager. I will get back to you soon if we have any additional participants. Thanks Susan Weisenberg, Environmental ScientistOffice:
ZjQcmQRYFpfptBannerStart
5/8/24, 11:47 AM State of Utah Mail - RE: BD Sandy UDAQ 24 April 2024 Inspection Records
https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1797804559056808176%7Cmsg-f:1797804559056808176&…5/8
Use caution opening attachments and links
ZjQcmQRYFpfptBannerEnd
Hello, I know that we will have a minimum of three, which will include myself, the EPA inspector, and my Section Manager. I
will get back to you soon if we have any additional participants. Thanks
Susan Weisenberg,
Environmental Scientist
Office: 385-306-6512

On Mon, Apr 15, 2024 at 9:51 AM Stephanie Rucks <[e-mail]> wrote:
Hello Susan,

Good morning. Could you please share the total number of inspectors we will have on site next Wednesday at BD
Medical in Sandy? Thank you.

Warm regards,
Stephanie
Stephanie Rucks
Site EHS Manager
Environmental Health & Safety
[e-mail]
9450 South State Street
Sandy, Utah, 84070
US
c: 801.200.0200
bd.com

BD Restricted
From: Stephanie Rucks <[e-mail]>
Sent: Thursday, January 18, 2024 2:02 PM
To: Susan Weisenberg <[e-mail]>
5/8/24, 11:47 AM State of Utah Mail - RE: BD Sandy UDAQ 24 April 2024 Inspection Records
https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1797804559056808176%7Cmsg-f:1797804559056808176&…6/8
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Cc: Chad Gilgen <[e-mail]>
Subject: Re: EPA scheduled Eto inspection for April 24, 2024

Hello Susan I received the messages. I appreciate all of the information and we are happy to have you all out. Let me if
there is anything you need from me as we get closer to the inspection date.

Warm regards,
Stephanie

Get Outlook for iOS
From: Susan Weisenberg <[e-mail]>
Sent: Wednesday, January 10, 2024 11:33 AM
To: Stephanie Rucks <[e-mail]>
Cc: Chad Gilgen <[e-mail]>
Subject: EPA scheduled Eto inspection for April 24, 2024

EXTERNAL EMAIL - Use caution opening attachments and links.
Hello, my name is Susan Weisenberg and I work for the State of Utah Division of Air Quality (DAQ). The Federal Environmental Protection Agency has informed our Division that they will be performing Eto sterilization inspections in our State
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ZjQcmQRYFpfptBannerEnd
Hello, my name is Susan Weisenberg and I
work for the State of Utah Division of Air Quality (DAQ). The Federal Environmental Protection
Agency has informed our Division that they will be performing Eto sterilization inspections in our State this April. They
have selected April 24, 2024 at approximately 9:30 a.m. for your BD Medical facility located at 9450 South State Street,
Sandy, Utah.

The inspection will be conducted as per our usual DAQ inspections as based on your current Approval Order and the
associated Federal Subparts for MACT O, ZZZZ, and NSPS IIII. A copy of the previous November 17, 2022 inspection
and your current AO has been attached for reference.

It is recommended that your company have a knowledgeable contact available for this inspection in order to provide the
site tour and have the applicable documents ready for review. Please contact me if you have any questions or
comments. Thank you for your time with this matter.
Susan Weisenberg,
Environmental Scientist
Office: 385-306-6512

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9 attachments
04E-7058 Emissions Calculations -April 2024 - Emissions Summary.pdf
179K
3 EO Use and Generator Run Apr 2023 through Mar 2024.pdf
116K
6B90242 - II.A.13 Boiler - Drawing.PDF
2650K
II.A.13 - Sterilization Boiler - Derating Factor for Altitude from ECI Inc. September 2005.pdf
146K
11269 02-24 - II.B.9 Molding Operations Cleaning Oven Calibration Certificate.pdf
99K
6308 CR 12-23 - II.B.4 Lesni Sterilization - Internal Tracker for Calibration.pdf
93K
6308 DS 12-23 - II.B.4 Lesni Sterilization Catalytic Oxidizer Calibration.pdf
188K
7392 CR 04-24 - II.B.6.c.1 Alliance RTO Calibration Certificate.pdf
95K
Snapshots of temperature tracking on the Oxidizers and Molding Cleaning Oven.docx
1455K
5/8/24, 11:47 AM State of Utah Mail - RE: BD Sandy UDAQ 24 April 2024 Inspection Records
https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1797804559056808176%7Cmsg-f:1797804559056808176&…8/8
Company:
Site:

Summary of Annual Emissions
04/1/2023 through 03/30/24
Total Criteria Emissions (tons/year) HAPs (tons/yr)
Emission Source PM10 PM2.5 SOx NOx
VOC
(including
HAPs)CO Lead
Condensab
le PM
PM10
Filterable PM2.5 Filterable
Total Combined
HAPs
Production
Combined HAPs
1 2b, 6a, 6b, 6h 5.27E-02 5.27E-02 4.16E-03 6.93E-01 3.81E-02 5.82E-01 3.46E-06 3.95E-02 1.32E-02 1.32E-02 7.85E-02
2 2b, 6a, 6c, 6h 2.37E-02 2.37E-02 1.87E-03 2.93E-01 1.71E-02 1.25E-01 1.56E-06 1.77E-02 5.91E-03 5.91E-03 3.53E-02
3a 2b, 6a, 6d, 6h 4.32E-03 4.32E-03 3.41E-04 3.94E-02 8.11E-02 2.14E-01 2.84E-07 3.24E-03 1.08E-03 1.08E-03 6.43E-03
3b 2b, 6a, 6e, 6h 2.96E-02 2.96E-02 2.34E-03 3.89E-01 2.14E-02 3.27E-01 1.95E-06 2.22E-02 7.40E-03 7.40E-03 4.41E-02
3c 2b, 6a, 6e, 6h 2.96E-02 2.96E-02 2.34E-03 3.89E-01 2.14E-02 3.27E-01 1.95E-06 2.22E-02 7.40E-03 7.40E-03 4.41E-02
3d 2b, 6a, 6e, 6h 7.82E-03 7.82E-03 6.17E-04 7.13E-02 1.47E-01 3.88E-01 5.14E-07 5.86E-03 1.95E-03 1.95E-03 1.16E-02
3e 2b, 6a, 6e, 6h 1.11E-02 1.11E-02 8.74E-04 1.46E-01 8.01E-03 1.22E-01 7.28E-07 8.30E-03 2.77E-03 2.77E-03 1.65E-02
3f 2b, 6a, 6f, 6h 5.53E-03 5.53E-03 4.37E-04 5.05E-02 1.04E-01 2.75E-01 3.64E-07 4.15E-03 1.38E-03 1.38E-03 8.24E-03
3g 2b, 6a, 6g, 6h 3.02E-03 3.02E-03 2.39E-04 2.76E-02 5.68E-02 1.50E-01 1.99E-07 2.27E-03 7.56E-04 7.56E-04 4.51E-03
Emissions from Diesel-Fueled North Generator (#1) NEW 4/2022 4a 4, 7a, 7b, 7c 4.79E-02 4.79E-02 8.31E-04 1.64E+00 4.39E-02 3.76E-01 - 1.34E-03 8.64E-03 8.34E-03 2.74E-04
Emissions from Diesel-Fueled West Generator (#2)4b 4, 7a, 7b, 7c 3.98E-02 3.98E-02 3.71E-02 5.61E-01 4.55E-02 1.21E-01 - 1.92E-03 1.24E-02 1.19E-03 1.78E-04
Emissions from Diesel-Fueled South/EO Generator (#3)4c 4, 7a, 7b, 7c 2.86E-02 2.86E-02 4.97E-04 9.82E-01 2.63E-02 2.25E-01 - 8.59E-04 5.53E-03 5.34E-03 1.76E-04
Emissions from Diesel-Fueled South Fire Pump (New 12/2022)4d 4, 7a, 7b, 7c 9.28E-03 9.28E-03 8.65E-03 1.31E-01 1.06E-02 2.82E-02 - 4.49E-04 2.89E-03 2.79E-04 4.17E-05
Emissions from Diesel-Fueled North Fire Pump 4e 4, 7a, 7b, 7c 5.04E-03 5.04E-03 4.70E-03 7.11E-02 5.76E-03 1.53E-02 - 2.43E-04 1.57E-03 1.51E-04 2.26E-05
Emissions from Diesel-Fueled Yard Tractor 4f 4, 7a, 7b, 7c 2.35E-03 2.35E-03 1.54E-04 3.05E-02 1.49E-03 9.58E-03 - 1.15E-04 7.39E-04 7.13E-04 1.82E-06
Emissions from Propane-Fueled Forklifts 5 5, 8a, 8c 7.73E-05 7.73E-05 7.67E-06 1.59E-02 3.55E-03 7.12E-02 - 5.80E-05 1.93E-05 1.93E-05 -
Cooling Tower Emissions 7(a-j)12 8.46E-02 8.46E-02 ---- -0.00E+00 8.46E-02 8.46E-02 -
VOC Emissions (including HAPs)- ----- - -- - -
6 9a, 9b - - - - 1.37E+01 - - - - - 2.35E-01
Catheter Production (Toolcrib)6 10a, 10b - - - - 6.33E-01 - - - - - 9.60E-03
Facility Maintenance 6 11a, 11b - - - - 1.81E-01 - - - - - 2.92E-04
Extrusion & Nextrusion (Beehive) tubing PM10 Emissions (includes cleaning oven) 13c 1.28E-04 1.28E-04 ---- -2.55E-02 2.30E-01 2.30E-01 -
Molding Silicone Annealing Ovens PM10 Emissions 13a 13a 1.40E-03 1.40E-03 ---- -1.40E-04 1.26E-03 1.26E-03 -
Molding Cleaning Oven emissions 14 13b 2.66E-04 2.66E-04 3.60E-05 5.42E-04 3.48E-04 1.00E-03 - 2.66E-05 2.39E-04 2.39E-04 6.66E-05
Lab Emissions - - - - 9.39E-02 - - - - - 5.60E-02
Fuel Storage Tanksa - - - - 2.97E-03 - - - - - -
Fugitive EO Emissions - ----- - -- - -
Dry Bed System Emissions - - - - 6.09E-02 - - - - - 6.09E-02
0.387 0.387 0.065 5.532 15.331 3.358 0.000011 0.156 0.390 0.374 0.611 0.000
5.71 6.14 0.76 16.76 31.34 13.23 N/A N/A N/A N/A 2.13 N/A
6.77% 6.30% 8.57% 33.01% 48.92% 25.38% N/A N/A N/A N/A 28.71% N/A
*Note permitted emissions are based on DAQE-AN103770013-22
a Emissions for fuel storage tanks for CY2022 were calculated using AP-42, Ch 7. Previously, they were calculated using a tool from Oklahoma DEQ, found at https://www.deq.ok.gov/air-quality-division/air-permits/storage-tank-emissions-calculation-tool/.
Emissions from Natural Gas-Fueled Equipment Operation
Residential Furnaces (< 0.3 MMBTU/hr capacity)
Emissions from Natural Gas-Fueled Equipment Operation EO
Sterilization HVAC
BD Medical Systems
9450 S. State Street, Salt Lake City, Utah
Supporting Table(s)
Emissions from Natural Gas-Fueled Equipment Operation
Small Boilers (< 100 MMBTU/hr capacity)
Point
Source
ID
Percent of Permitted Emissions
Emissions from Natural Gas-Fueled Equipment Operation Lesni RTO
(installed 02/09)
Emissions from Natural Gas-Fueled Alliance Thermal Incinerator
(BACT associated with the proposed PBBCS process)
Emissions from Natural Gas-Fueled Equipment Operation EO
Sterilization Boiler #1
Emissions from Natural Gas-Fueled Equipment Operation EO
Sterilization Lesni
Total Criteria Pollutant Emissions (tons/year)
Permitted Emissions (tons/year)
Catheter Production (SAP) (Includes emissions from
Extrusion, Nextrusion, Annealing ovens)
Emissions from Natural Gas-Fueled Equipment Operation EO
Sterilization Boiler #2
Emissions from Natural Gas-Fueled Equipment Operation Alliance
Boxidizer RTO (installed 9/19)
# BD Restricted
Hazardous Air Pollutants
CAS # HAP Name
Total HAP Emissions
(lbs/year)
Total HAP
Emissions
(tons/year)HAP Y/N VOC Y/N
100-41-4 Ethyl Benzene 8.97E-01 4.48E-04 YY
100-42-5 Styrene 1.34E+00 6.71E-04 YY
101-68-8 4,4'-diphenylmethane diisocyanate (MDI) 1.67E-02 8.36E-06 YY
106-99-0 1,3-Butadiene 4.91E-03 2.46E-06 YY
107-02-8 Acrolein 1.62E-02 8.11E-06 YY
107-21-1 Ethylene Glycol 3.39E+00 1.69E-03 YY
108-05-4 Vinyl Acetate 0.00E+00 0.00E+00 YN
108-10-1 methyl isobutyl ketone 0.00E+00 0.00E+00 YY
108-88-3 toluene 6.05E-01 3.03E-04 YY
109-16-0 Triethyleneglycol dimethacrylate 0.00E+00 0.00E+00 YY
110-54-3 hexane 8.05E+01 4.02E-02 YY
111-42-2 2,2'iminodiethanol 3.10E+02 1.55E-01 YY
111-46-6 diethylene glycol 1.28E+01 6.38E-03 YY
111-76-2 2-butoxyethanol 0.00E+00 0.00E+00 YY
121-44-8 Triethylamine 0.00E+00 0.00E+00 YN
123-31-9 hydroquinone 6.39E-02 3.20E-05 YY
127-18-4 perchloroethylene 0.00E+00 0.00E+00 Y Y TPY
1330-20-7 xylene 1.96E+00 9.79E-04 YY Total Greenhouse Gas Equivalent Emissions (tpy)
50-00-0 Formaldehyde 8.22E+00 4.11E-03 Y Y Actual CO2e Emissions (tpy) 2,907.15
540-84-1 isooctane 4.42E+01 2.21E-02 Y Y Permitted Amount (tpy) 20,285.00 from DAQE-AN103770013-22
584-84-9 toluene diisocyanate 0.00E+00 0.00E+00 Y Y % of Permitted Amount 14.33%
67-56-1 methanol 1.03E+02 5.17E-02 YY
67-66-3 Chloroform 0.00E+00 0.00E+00 YN
68-12-2 N, N-Dimethylformamide 0.00E+00 0.00E+00 YN
71-43-2 Benzene 6.53E-01 3.27E-04 YY
7439-96-5 Manganese 1.67E-02 8.36E-06 YN
7439-97-6 Mercury 1.14E-02 5.72E-06 YN
7440-02-0 Nickel 9.24E-02 4.62E-05 YN
7440-38-2 Arsenic 8.80E-03 4.40E-06 YN
7440-41-7 Beryllium 5.28E-04 2.64E-07 YN
7440-43-9 Cadmium 4.84E-02 2.42E-05 YN
7440-47-3 Chromium 6.16E-02 3.08E-05 YN
7440-48-4 Cobalt 3.70E-03 1.85E-06 YN
75-05-8 Acetonitrile 0.00E+00 0.00E+00 YN
75-07-0 Acetaldehyde 1.11E-01 5.56E-05 YY
75-09-2 Dichloromethane (Methylene Chloride) 0.00E+00 0.00E+00 YN
75-21-8 Ethylene oxide 4.70E+00 2.35E-03 YY
7647-01-0 Hydrochloric Acid 0.00E+00 0.00E+00 YY
7782-49-2 Selenium 1.06E-03 5.28E-07 YN
79-01-6 trichloroethylene 0.00E+00 0.00E+00 YY
79-10-7 Acrylic Acid 6.05E-03 3.03E-06 YY
91-20-3 Naphthalene 1.12E-01 5.59E-05 YY
92-52-4 Biphenyl 0.00E+00 0.00E+00 YN
98-82-8 Cumene 2.58E-02 1.29E-05 Y N
TOTAL HAPs Emissions (lbs/year)573.58 0.2868
Production Operations Combined HAPS
Formaldehyde, Ethylene Glycol, Toluene, 2,2'iminodiethanol, Xylene)
CAS #
Total HAP Emissions
(lbs/year)
Total HAP
Emissions
(tons/year) HAP Y/N VOC Y/N
75-21-8 Ethylene oxide 4.695 0.002348 Y Y
110-54-3 hexane 80.471 0.040235 Y Y
123-31-9 hydroquinone 0.064 0.000032 Y Y
101-68-8 4,4'-diphenylmethane diisocyanate (MDI) 0.017 0.000008 Y Y
584-84-9 toluene diisocyanate 0.000 0.000000 Y Y
67-56-1 methanol 18.977 0.009488 Y Y
75-09-2 Dichloromethane (Methylene Chloride) 0.000 0.000000 Y N
108-10-1 methyl isobutyl ketone 0.000 0.000000 Y Y
127-18-4 perchloroethylene 0.000 0.000000 Y Y
108-88-3 toluene 0.605 0.000303 Y Y
540-84-1 isooctane 44.153 0.022076 Y Y
50-00-0 Formaldehyde 8.223 0.004112 Y Y
107-21-1 Ethylene Glycol 3.385 0.001693 Y Y
111-42-2 2,2'iminodiethanol 310.370 0.155185 Y Y
100-42-5 Styrene 1.343 0.000671 Y Y
1330-20-7 xylene 1.958 0.000979 Y Y
474.260 0.237Total Production Combined HAPS
HAP Name
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
PM10 PM2.5 SOx NOx VOC
(including
HAPs)
CO Lead Condensable
PM
PM10
Filterable
PM2.5
Filterable
Total
Combined
HAPs
Production
Combined
HAPs
Pe
r
c
e
n
t
Emission Type
Percent Actual Emissions vs Permitted
April 2023 through March 2024
# BD Restricted
3 EO Use and Generator Run Apr 2023 through Mar 2024
Make Cummins Stamford John Deere John Deere
Point Source ID 4a 4b 4c 5d 4d
Model DQCA 2180054 UCDI274J1 DFGE5742022 4045HFC28 JW6H-UFADF0
Serial #B220044989 X17I376440 C060899591 SO169247P
Date Installed 04/10/2022 06/11/2021 06/21/2006 06/01/2018 11/14/2022
Function Backup Power Backup Power Backup Power
Fire Supression
System Pump
Fire Supression
System Pump
Location North West EO (South)
Fire Supression
System Building
North
Fire Supression
System Building
South (new)
Fuel Diesel Diesel Diesel Diesel Diesel
Fuel Useage (gal/hr)12 7.5 17.2 10.6
Capacity (hp)1220 410 938.5 157
Actual Hours Actual Hours
DAQ
Standard
Hours Actual Hours
DAQ
Standard
Hours Actual Hours
DAQ Standard
Hours Actual Hours DAQ Standard Hours
Jan-24 8.1 8.33 6.8 8.33 6.7 8.33 2 8.33 2 8.33
Feb-24 4 8.33 1.7 8.33 2.2 8.33 2 8.33 2 8.33
Mar-24 3.1 8.33 1.4 8.33 1.7 8.33 2.5 8.33 2.5 8.33
Apr-23 2.6 8.33 1.2 8.33 1.9 8.33 2 8.33 1.5 8.33
May-23 11.6 8.33 6.9 8.33 7.4 8.33 2.4 8.33 2.1 8.33
Jun-23 1.5 8.33 0.7 8.33 0.4 8.33 2.5 8.33 2.5 8.33
Jul-23 67 8.33 62.6 8.33 62.9 8.33 7 8.33 5.8 8.33
Aug-23 26 8.33 1.3 8.33 1.7 8.33 2.5 8.33 2.5 8.33
Sep-23 3.2 8.33 1.4 8.33 1.7 8.33 2 8.33 2 8.33
Oct-23 3.1 8.33 1.3 8.33 1.7 8.33 2.2 8.33 2.2 8.33
Nov-23 3.3 8.33 1.5 8.33 1.9 8.33 2 8.33 2.4 8.33
Dec-23 3.2 8.33 1.3 8.33 1.6 8.33 2.5 8.33 2 8.33
TOTAL Hours 136.7 100.00 88.1 100.00 91.8 100.00 31.6 100.00 29.5 100.00
12 month rolling
Maintenance, Testing
hours of operation 69.7 25.5 22.2 31.6 29.5
Emergency run times 67 59.9 62.4
Apr 2023 through Mar 2024
Generator Run Hours
See S:\Facilities\PM Spread Sheet Log\Generator Log.xlsx for Generators run times. Diesels automatically do an exercise run of approximately 20 minutes every Saturday morning.
# BD Restricted
3 EO Use and Generator Run Apr 2023 through Mar 2024
5,029 03/31/2023
Air Permit Max EO
Use in any 12 mo.
213,300
pounds
140,000
5,393 03/31/2024 Kg
139,636 63337.77251
Oxidizer Date
Total
Time
(hours) Reason
Lesni RTO By-pass Time
04/05/2023 0.7
restart after
compressed air
failure
04/26/2023 4.2 6 month PM
Air Permit Lesni
RTO maximum by-
pass time in any 12
running months
Hours
Remaining
07/01/2023 1.4
Restart after power
outage 96 74.9
07/02/2023 0.8
Cleaned igniter and
restarted after flame
failure alarm
07/13/2023 1.2
Restart after power
outage
07/16/2023 1.7
Replaced actuator to
valve 21.306
07/17/2023 1.8
Replaced position
sensor on 21.306
10/30/2023 4.1 6 Month PM
11/14/2023 3.2
Restart after
compressed system
failure
12/15/2023 2
Restart from power
bump to plant from
R.M.P.
TOTAL: 21.1
Alliance RTO
04/19/2023 4.5 6 month PM
05/18/2023 3.8
Restart after power
bumb. Replaced
ignition transformer
Air Permit Alliance
RTO maximum by-
pass time in any 12
running months
Hours
Remaining
06/30/2023 9.6
Repaired bad valve
disk 96 72.3
07/13/2023 0.4
Restart after power
outage
10/25/2023 4.5 6 month PM
12/15/2023 0.9 Power failure
TOTAL: 23.7
Boxidizer RTO
04/20/2023 2.9 6 month PM
10/17/2023 0.3 Restarted unit
10/17/2023 0.3 Restarted unit
10/26/2023 2.5 6 Month PM
11/14/2023 0.5 Restarted Unit
12/15/2023 0.6 Restarted unit
Air Permit
Boxidizer
maximum by-pass
time in any 12
running months
Hours
Remaining
12/18/2023 1.9 Restarted unit 96 69.3
12/18/2023 0.2 Restarted unit
01/02/2024 17.5
Ran overnight until
fixed
TOTAL: 26.7
Less EO Inventory on last day of 12 month period:
Total EO rolling 12 month:
Ethylene Oxide Total Usage (lbs)
Add EO Inventory on last day of prior month:
Add EO Total Delivered current 12 months: (From EO
Delivery Log)
# BD Restricted
Asset ID: 7392 Work ID: CAL-55410
Description:500-1600°F (PBBCS RTO B Lower)
Equipment Type:Temperature Controller
Manufacturer:Allen Bradley
Model:N/A
Serial Number:N/A
Location://Sandy/Facilities Maintenance/Roof
Calibration Range:500-1600°F
Use Range:500-1600°F
Required Tolerance:±10°F
Precision:N/A
Schedule and Work Information
Calibration Date:26 Apr 2024 Calibration Procedure:MET-001
Due Date:30 Apr 2024 Interval:Monthly - End of Month 12
Next Due Date:30 Apr 2025 Completed By:Julio Alvarez
Measurement Data
#Target Standard Lower Upper As Found As Left
Setpoint Units Tol.Tol.Standard Instrument Error Standard Instrument Error
1 500 ° F 10 10 500 499 -1 500 499 -1
2 1000 ° F 10 10 1000 999 -1 1000 999 -1
3 1600 ° F 10 10 1600 1599 -1 1600 1599 -1
Results
As Found: Out of Tolerance As Left: Pass/Fail Work Type Other
[ ]Yes
[ X ]No
[ ]N/A
[ X ]Pass
[ ]Fail
[ ]N/A
[ ]Full Calibration
[ X ]Limited Calibration
Temperature
Humidity
Comments:
Standards Used
Standard ID Standard Type Due Date
10367 Digital Temperature Calibrator 31 Mar 2025
Electronic Signatures
Signed By Date / Time Reason
Julio Alvarez 26 Apr 2024 10:27:33 AM Completed By
Thomas Alires 29 Apr 2024 10:01:28 AM Approver
Printed: 29 Apr 2024 21:21:39 GMT Page 1 of 1
Report Name: CalibrationReport
Note: All date/time fields displayed indicate the time zone for the geographical location of the source’s (site’s) dataset.
CONFIDENTIAL: This document is not to be distributed or copied except by or with the permission of Becton Dickinson and Company
Calibration Report
C e r t i f i c a t e o f C a l i b r a t i o n
6308
Asset Number:
916490
Certificate Number:
Western States Calibration certifies this instrument has been cleaned, calibrated and inspected in accordance with said Instrument Calibration
Procedure. This calibration was performed in accordance with requirements of ISO/IEC 17025, and ANSI/NCSL Z540-1 with measuring
standards traceable to the International System of Units (SI) through National Institute of Standards and Technology or other National
Measurement Institutes or accepted fundamental and or physical constants. The results reported on this certificate apply only to the item
calibrated. All data is reported as raw data and uncorrected for uncertainty or environmental effects. It is the end user’s responsibility to
determine fitness for use. For statements of conformity a simple 1:1 acceptance decision rule per ASME B89.7.3.1applies. This decision rule
results in an estimated Probability of False Accept (PFA) of <2%. The reported expanded uncertainty of measurement (EMU) is stated as the
standard uncertainty of measurement multiplied by the coverage factor k=2 such that the coverage probability corresponds to approximately 95%.
This certificate shall not be reproduced except in full, without the written approval of Western States Calibration.
Customer:BD Medical
Sandy, Utah 84070
Thomas Alires
9450 South State Street 07/31/2024
7 MonthsInterval:
Date Done:
Date Due:
12/28/2023
TrueCal'd at Customer Site:
12/18/2023Received Date:
600 °C
6308
In Tolerance
In ToleranceUNKNOWN
Unknown
Thermocouple
Serial Number:
Asset Number:
Description:
Model Number:
Manufacturer:
Condition As Left:
Condition As Found:
FalsePhysical Damage:
Sterilization TTICH 25.610Location:
Standards Used
Standard ID Due DateDescriptionModel NumberManufacturer Trace #
WSC752 Fluke Corp 754 Calibrator, Documenting Process 05/30/2024886354
WSC725 Fluke Corp 9173 Well, Metrology 08/24/2024895462
Procedure/s Used
Procedure Number Procedure Name Revision No.Revision Date
10653 Thermocouples -100 °F to 2500 °F (#10653)0 04/22/2005
Measurement Data
EMUTAR | TURCalibration Tolerance
g: = Guard Banding
OOTMeasured ValueFunction Tested Nominal / Reference
Value
% Error
Temperature Transmitter
Simulation
4 mA
61:10 °C 0 ± 0.58 °CAs Found & As Left -6 to 6 °C 0 %10:1
8 mA
73:1150 °C 150 ± 0.58 °CAs Found & As Left 144 to 156 °C 0 %10:1
12 mA
50:1300 °C 300 ± 0.59 °CAs Found & As Left 294 to 306 °C 0 %10:1
16 mA
41:1450 °C 450 ± 0.59 °CAs Found & As Left 444 to 456 °C 0 %9:1
20 mA
35:1600 °C 600 ± 0.6 °CAs Found & As Left 594 to 606 °C 0 %9:1
Temperature
56:150 °C 49 ± 0.59 °CAs Found & As Left 44 to 56 °C -17 %10:1
43:1150 °C 150 ± 0.59 °CAs Found & As Left 144 to 156 °C 0 %9:1
37:1300 °C 300 ± 0.6 °CAs Found & As Left 294 to 306 °C 0 %9:1
37:1600 °C 601 ± 0.6 °CAs Found & As Left 594 to 606 °C 17 %9:1
(0 % Error of Limit - May represent a condition with an Asymmetrical Tolerance that can not be calculated.)
Sirstins, Eric
Lon MilesQuality Manager:
Humidity:
Temperature:56.1 ºF
31.2 %
12/29/2023Calibration Technician
Cert. Issued by:Nunez, Adam
westerncal.com phone [phone] fax [phone] 105 west 2950 south salt lake city, utah 84115.3433
Page 1 of 1
Asset ID: 11269 Work ID: CAL-54638
Description:1400-1800°F (Limited)
Equipment Type:Temperature Controller
Manufacturer:PGC
Model:N/A
Serial Number:N/A
Location://Sandy/Molding West/Mold
Maintenance Shop
Calibration Range:1400-1800°F (Limited)
Use Range:1400-1800°F
Required Tolerance:±20°F
Precision:N/A
Schedule and Work Information
Calibration Date:14 Feb 2024 Calibration Procedure:MET-001
Due Date:29 Feb 2024 Interval:Monthly - End of Month 12
Next Due Date:28 Feb 2025 Completed By:Thomas Alires
Measurement Data
#Target Standard Lower Upper As Found As Left
Setpoint Units Tol.Tol.Standard Instrument Error Standard Instrument Error
1 1400 ° F 20 20 1400 1393 -7 1400 1393 -7
2 1500 ° F 20 20 1500 1494 -6 1500 1494 -6
3 1600 ° F 20 20 1600 1592 -8 1600 1592 -8
4 1700 ° F 20 20 1700 1692 -8 1700 1692 -8
5 1800 ° F 20 20 1800 1791 -9 1800 1791 -9
Results
As Found: Out of Tolerance As Left: Pass/Fail Work Type Other
[ ]Yes
[ X ]No
[ ]N/A
[ X ]Pass
[ ]Fail
[ ]N/A
[ ]Full Calibration
[ X ]Limited Calibration
Temperature
Humidity
Comments:
Standards Used
Standard ID Standard Type Due Date
5776 Digital Temperature Calibrator 31 Mar 2024
Electronic Signatures
Signed By Date / Time Reason
Thomas Alires 20 Feb 2024 10:14:35 AM Completed By
Julio Alvarez 21 Feb 2024 5:44:09 PM Approver
Printed: 30 Apr 2024 20:27:48 GMT Page 1 of 1
Report Name: CalibrationReport
Note: All date/time fields displayed indicate the time zone for the geographical location of the source’s (site’s) dataset.
CONFIDENTIAL: This document is not to be distributed or copied except by or with the permission of Becton Dickinson and Company
Calibration Report
BD Medical: Snapshots of temperature logs
24 April 2024 UDAQ Inspec�on
Page 1 of 3
II.B.4.c (2 pictures) Steriliza�on
Cataly�c Oxidizer
BD Medical: Snapshots of temperature logs
24 April 2024 UDAQ Inspec�on
Page 2 of 3
II.B.7.d Boxidizer RTO
BD Medical: Snapshots of temperature logs
24 April 2024 UDAQ Inspec�on
Page 3 of 3

949 East Mill Street / P O Box 271 
Bountiful, Utah 84010 
PH: (801) 295‐4404 
FX: (801) 295‐4425

September 22, 2005

Eric D. Wells
Mechanical Service and Systems Inc.
6906 South 300 West
Salt Lake City, UT 84047

Re: Resubmittal for Becton-Dickinson project

Eric,

Attached are the itemized points referenced by Mr. Babeur of CH2MHILL regarding the Beckton
Dickinson boilers. Items #3 and #4 were quoted to be provided by others. There should,
however not be a need to insulate most of the FGR pipe as it runs at the height of the boiler.

Also note that while the boiler flue size increased to 18” I.D. from 16” I.D., we will provide the
larger flue at the same price quoted for the 16” I.D. material.

Sincerely,
Steve
ECI

RESUBMITTAL INFORMATION

PROJECT: BECTON DICKINSON

DATE: SEPTEMBER, 21, 2005

EQUIPMENT: BOILERS

SUPPLIER: ENERGY CONSORTIUM INDUSTRIES

ITEMS: 1. Boiler / Burner Performance
2. Location of Boilers / Flue Location
3. Flue Gas Recirculation (FGR) Piping / Insulation
4. Boiler Access Platform
5. Boiler Dimensions
6. Rear Door Swing Clearance on Boilers

Item #1 Boiler / Burner Performance

Boiler design is for ratings and capacities up to 200 HP, 6695 MBH Gross Output with an Input of
8369 MBH, however the 8,400 MBH Input Industrial Combustion burner when derated for 4500
feet elevation firing will meet the required output of 177 BHP.

Item # 2 Location of Boilers / Flue Location

The Superior Boilers should face towards the center of the room. This positioning offers several
advantages.

1. As three pass boilers, this would keep the flue outlet in the same location as shown
on the drawings.
2. With the flues in the same location as shown on the drawings, the air handler can
also remain as located. As the Superior Boiler length is approx. the same length as
the boilers shown on the drawings, care should be taken in the field to assure that
the 10 foot minimum spacing from the air intake of the unit is met.
3. With the rear of the Superior Boilers facing the roll-up doors, tube removal will be
much easier than removing the front of the Cleaver Brooks boilers in addition to not
having to disconnect the burners

Item # 3 Flue Gas Recirculation (FGR) Piping / Insulation

Flue gas recirculation (FGR) piping was included in quotation for boiler package, with insulation, if
required, to be by others. Size of pipe to be 6" and will be installed at the factory along the top of
the boilers as shown on the drawings, with only a short segment reaching down to the burner
connection. FGR pipe to be assembled at the factory and painted to match the boiler.

RESUBMITTAL INFORMATION (Cont.)

PROJECT: BECTON DICKINSON

DATE: SEPTEMBER, 21, 2005

EQUIPMENT: BOILERS

SUPPLIER: ENERGY CONSORTIUM INDUSTRIES

ITEMS: 1. Boiler / Burner Performance
2. Location of Boilers / Flue Location
3. Flue Gas Recirculation (FGR) Piping / Insulation
4. Boiler Access Platform
5. Boiler Dimensions
6. Rear Door Swing Clearance on Boilers

Item #4 Boiler Access Platform

Boiler access platform as per quotation to be provided by others.

Item #5 Boiler Dimensions

Boiler dimensions are as follows:

Overall Length: 230 ¾”
Overall Height: 92” To top of stack
Overall Width: 80”

Further dimensions and locations of boiler / burner trim is found on attached drawing.

Item #6 Rear Door Swing Clearance on Boilers

Rear door swing on boilers to be 62" maximum rear swing, and 44" maximum side swing. (See
attached reference chart)
r-----------------------------------L--------------------~---------------
6" FGR
PIPING
STACK DAMPER
W/LOCKING QUAD
N
TOP OF STACK
92±1 73 67
12
BOILER CONNECTIONS
A.(1) STEAM OUTLET 6"-300# FLANGE
B.(4) LWC0 ______ 1'_' _NP_T __
C.(2) SAFETY VALVE ___ 2'_' _NP_T __
D.( ) SAFETY VALVE _____ _
E.(2) BOILER BLOWDOWN __ 1_1~/4_"_N_P_T_
F.(1) SURFACE BLOWDOWN _1'_' _NP_T __
G.( 1) MAN WAY _____ 1_2_" _x_1_6_" _
H.( 4) HAN DH OLE ___ _____..c3_" ---'-x'-4-'--"--
J.( 1) CLEAN OUT PORT ___ 17_"_1.c..._D __
K.(2) FEEDWATER ____ 2''_N_P_T __
L.( 1) AUXILIARY /VENT __ -=2_" -'-'-NP'-T'---_
M.( 1) LOW FIRE HOLD --~1 /_2_" _N_PT __
N.(1) STACK TEMP ---~1/_2_" _N_PT __
P.(1) SIGHTPORT ____ 1_"_P_IP_E __
Q.(1) CHEMICAL FEED ___ 1'_' _NP_T __
R.( ) ---------S.( )
HYDAC 3000 WARRICK PROBE
ALWCO
MM193A-7B
LWCO
PIPING
62(1) 85 (2)
DOOR SWING
80±1
TOP OF FGR
144 170
TUBE CLEARANCE
21~
TOP OF STEAM NOZZLE
G
125
TUBE CLEARANCE
18 62(1) 44(2)
DOOR SWING
92±1 ~I--------------
117
1Bi
REF 30 12~ 18 115 8
212±1
RATINGS & CAPACITIES LTR DATE REVISION BY REPRESENTATIVE:
HORSEPOWER 200 * A 9-19-05 BOILER MODEL WAS 4-X-1024-ICCF-G ENERGY CONSORTIUM -----------DES I G N PRESSURE 150 PSIG STEAM ----------
GROSS OUTPUT 6 695 MBH * -----~-----
STEAM (FROM & AT 212'F) _6=·~90~0~Lb'-'-/~H~r *--,_ ___________________________________ PROJECT:
HEAT RELEASE: (FURNACE ONLY) 151,784 BTU /Cu Ft* l---+---+--------------------------------+-----1 RATED INPUT 8 369 MBH * ----------"-'--'--'-~~-'----
BECKTON DICKSON
HE A Tl NG SURFACE (ASME) ___ 1_00_5_S_q.._F_t __
FURNACE HEATING SURFACE _ ____c_91'-'-.5"-4----'--Sg=-F--'-t __ 1-~---------------------r----------.-----,=-,-,=:---=-:-~--.-----=-:-:=----r-----------1 NOTES I!:> CHECKED BY DATE
FURNACE VOLUME: ~~ S. ANDERSON 9-6-05 THIS DRAWING IS THE PROPERTY
FURNACE ONLY 55 14 Cu Ft 1. ALL CONTROLS MOUNTED AS PER SPECIFICATION SHEET. ~ >---~~~---~~__, OF SUPERIOR BOILER WORKS & -------·----OILER WORKS, INC. DRAWN BY DATE
STEAMING VOLUME ------=28=•..;;_81'----"-Cu=F--'-t__ 2. SPECIFICATION SHEET TAKES PRIORITY OVER R & D SHEET. HuTcH1NsoN, KANsAs B. McCOY 9-6-05 SHALL NOT BE REPRODUCED IN 3. REAR DOOR SWING: STEAM RELEASE AREA ____ 4_9._49_S~gF_t__ (1) MIN SIDE, MAX REAR MOHAWK BOILER MODEL PART OR IN WHOLE, & NONE OF
WATER CAPACITY: (2) MAX SIDE, MIN REAR MS4-X-1000-S150-ICCF-G ITS INFORMATION SHALL BE
(FULL) 1,488 Gal @ 12,374 Lbs 4. BOILER DESIGN CODE ASME SECTION I . 1-----------.-----------------1 REVEALED WITHOUT PERMISSION
( ) @ 10,582 Lbs 5. BOILER IN SULA TED WITH 2" -8# DENSITY MINERAL FIBER SCALE DRAWING No OR TO THE DETRIMENT OF THE
NWL 1•272 Gal INSULATION WITH 22 GAUGE STEEL JACKET. OWNER. IT MUST BE RETURNED
SHIPPING WEIGHT: ___ 2_0~0_0_0 _L_bs___ 6. ALL DIMENSIONS ARE ±1 /2" UNLESS OTHERWISE NOTED. 1 / 48 6 B 9 Q 2 4 2 UPON REQUEST.
* 7. HORSEPOWER & RELATED INFO BASED ON 5 SqFt FIRING.

DAQC-361-23
Site ID 10377 (B4)
MEMORANDUM

TO: STACK TEST FILE – BD MEDICAL

THROUGH: Rik Ombach, Minor Source Oil and Gas Compliance Section Manager

FROM: Paul Bushman, Environmental Scientist

DATE: March 24, 2023

SUBJECT: Source: Lesni Catalytic Oxidizer (II.A.2)
Location: 9450 State Street, Sandy, Salt Lake County, UT
Contact: Jon Anderson: 385-237-6340
Tester: Montrose Air Quality Services
Site ID #: 10377
Permit/AO #: DAQE-AN103770013-22 dated June 7, 2022
Action Code: TR
Subject: Review of stack test report dated March 17, 2023

On March 17, 2023, DAQ received a test report for the Lesni Abatement System at BD Medical in Salt
Lake County, Utah. Testing was performed January 19, 2023, to determine compliance with the emission
limits found 40 CRF 63 Subpart O, Ethylene Oxide Emissions Standards for Sterilization Facilities. The
DAQ-calculated test results are:

Source Test Date Test
Method Pollutant Tester Results DAQ Results Limits
Catalytic
Oxidizer Inlet
January 19,
2023 320 Ethylene
Oxide
39.0 lb/hr 38.9 lb/hr * 1159 ppmvw 1159.5 ppmvw
Catalytic
Oxidizer Outlet
January 19,
2023 320 Ethylene
Oxide
0.00113 lb/hr 0.00113 lb/hr * 0.0343 ppmvw 0.0343 ppmvw

Total Destruction Efficiency = 100.00% - 0.0343 ppmvw/1159.5 ppmvw x 100 = 99.997%

*There are no emission limits in the AO. The destruction efficiency requirements are located in 40 CFR
63 Subpart O 63.362(a) that stipulate a destruction efficiency of >99%.

DEVIATIONS: None.

CONCLUSION: The stack test appears to be acceptable.

RECOMMENDATION: The ethylene oxide reduction efficiency was in compliance with the
applicable limits at the time of testing.

ATTACHMENTS: DAQ stack test review spreadsheets, Montrose Air Quality Services
stack test report.

2020 Emissions Inventory Report
BD Medical - Medical Device Fabricating and Drug Manufacturing Plant (10377)
Emissions Summary
CRITERIA AIR POLLUTANT (CAP) EMISSIONS TOTALS
Pollutant Code/CAS #Pollutant Name Emissions
(tons, excluding
tailpipe)
Tailpipe
Emissions
(tons)
Total Emissions
(tons)*
PM10-PRI PM10 Primary (Filt + Cond)0.65054 0.14369 0.79424
PM10-FIL PM10 Filterable 0.47529 0.12402 0.59931
PM25-PRI PM2.5 Primary (Filt + Cond)0.64741 0.14369 0.79111
PM25-FIL PM2.5 Filterable 0.47229 0.12399 0.59628
PM-CON PM Condensible 0.17487 0.01967 0.19455
SO2 Sulfur Dioxide 0.30748 0.13378 0.44126
NOX Nitrogen Oxides 4.82491 2.04912 6.87403
VOC Volatile Organic Compounds 16.31944 0.16962 16.48906
CO Carbon Monoxide 3.2134 0.55286 3.76626
7439921 Lead 0.00001 <.00001 0.00001

HAZARDOUS AIR POLLUTANT (HAP) and/or OTHER POLLUTANT EMISSIONS TOTALS
Pollutant Code/CAS #Pollutant Name Is VOC/PM? Total Emissions
(tons)*
111422 Diethanolamine (HAP)VOC 0.156
75218 Ethylene Oxide (HAP)VOC 0.02167
50000 Formaldehyde (HAP)VOC 0.00408

*Rounded to 5 digits past the decimal point. Note that where rounding results in 0, <.00001 is indicated.
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