Document 2Jd7Q5OydrV4yN783Z3oGmw8N
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 4
ATLANTA FEDERAL CENTER 61 FORSYTH STREET SW
ATLANTA, GETORGIA 30303-8960
SENT VIA ELECTRONIC MAIL
Doug Parzuchowski General Manager International Sterilization Laboratory 217 Sampey Road Groveland, Florida 34736 dparzuchowski@isl-fl.com
Dear Doug Parzuchowski:
On August 15, 2023, the U.S. Environmental Protection Agency Region 4 Air Enforcement Branch conducted a partial compliance inspection at International Sterilization Laboratory, located in Groveland, Florida. Enclosed is a copy of the final report generated by the U.S. Environmental Protection Agency's Region 4, South Air Enforcement Section.
Should you have questions regarding this inspection report, contact me at (404) 562-8837, or by email at Slade.Daniel@epa.gov.
Sincerely,
Digitally signed by DANIEL
DANIEL SLADE SLADE Date: 2023.09.20 11:19:20 -04'00'
Daniel Slade Environmental Engineer South Air Enforcement Section
CC: Jennifer Parker, Florida DEP Talia Ayala, Florida DEP Jeffery Koerner, Florida DEP
United States Environmental Protection Agency (EPA) Region 4 Air Enforcement Branch Inspection Report
I. GENERAL INFORMATION
Facility Name: International Sterilization Laboratory
Location (Address): 217 Sampey Road Groveland, Florida 34736
Inspection Date: August 15, 2023
Type of Inspection (Full or Partial Compliance Evaluation): Partial Compliance Evaluation
PROGRAMMATIC ID: FL0000001206904823
PERMIT NUMBER: Permit # 0694823-012-AO
EPA Region 4 Investigator(s)/Inspector(s): 1. Daniel Slade, Environmental Engineer 2. Steve Rieck, Environmental Scientist
State/Local Investigator(s)/Inspector(s): 1. Jennifer Parker, Florida DEP 2. Talia Ayala, Florida DEP 3. Jeffery Koerner, Florida DEP
Person(s) Contacted at Facility (Name and Title): 1. Doug Parzuchowski, General Manager
Report Prepared by: Daniel Slade
II.
FACILITY INFORMATION
A. Facility and Permit Information
Facility and Permit Information
Comments
1. Type of facility (e.g., chemical plant, refinery, cement manufacturer, etc.).
2. Air permit number(s) and type of permit (e.g., Title V, PSD, Synthetic Minor, etc.).
3. Air permit issuance date.
Medical Device Sterilizer Permit # 0694823-012-AO December 22, 2020
4. Air permit expiration date.
December 22, 2025
5. Facility classification (Major, Synthetic Minor/Conditional Major, Minor).
6. Major source pollutants (if applicable).
7. Applicable regulations (e.g., State Implementation Plan, MACT Subpart FFFF, NSPS Subpart EEEE, etc.).
8. Types of air emission points (e.g., tanks, process vents, boilers, etc.).
9. Types of air pollution control equipment (e.g., baghouse, scrubber, afterburner, etc.).
Minor
Hazardous Air Pollutants (HAPs) - Ethylene Oxide 40 C.F.R. Part 63, Subpart O - Ethylene Oxide Emissions Standards for Sterilization Facilities
Sterilizer chambers and aeration room vents capture emissions and route to control equipment Acid-water scrubbers
B. Process Description
International Sterilization Laboratory receives pre-packaged medical equipment from manufacturers. The medical equipment, already packaged and palletized, is pre-conditioned in an enclosed space to a specific temperature and humidity to improve sterilization efficiency.
Following pre-conditioning, equipment is loaded into one of four sterilization chambers. The chambers are sealed, a vacuum is drawn to remove the air in the chamber, and ethylene oxide (EtO) gas is injected. Residence time in the chamber is dependent upon customer specifications. After the residence time has been reached, the ETO is purged from the chamber and routed to
an acid-water scrubber. The chamber undergoes nitrogen and air purges to improve EtO removal.
Equipment is then taken to one of two aeration chambers. The facility operates one hot chamber (increased temperature and humidity) and one cold chamber (ambient air conditions). Equipment is kept in the chambers for approximately 24 hours to allow residual EtO to off-gas from material. The residual EtO is captured and routed to an acid-water scrubber. Equipment is moved to the facility's storage area until it is sent back to the customers.
III. INSPECTION ACTIVITIES
Activity
Opening Meeting 1. Date and time entered the
facility.
Yes No NA
Y
2. Credentials presented to facility Y personnel (include name and title).
3. Conducted an opening meeting Y to explain the purpose and objectives of the inspection.
4. Discussed safety issues.
Y
5. Discussed which records to be Y reviewed.
6. Discussed the facility walk-
Y
through and the areas to be
observed in the facility.
7. Discussed facility policy
N/A
regarding photographs or video
(if applicable).
8. Discussed the use of the
Y
infrared camera, TVA, PID,
and any other equipment.
Comments
The EPA Region 4 inspection team and Florida DEP inspectors arrived at the facility on August 15, 2023, at 8:30 AM EDT. Upon arrival, EPA inspectors presented credentials to Lori Zelenitz-Swisher, Quality Assurance Manager. The inspection team held an opening conference with Doug Parzuchowki, General Manager, to discuss inspection objectives. The inspection team discussed appropriate personal protective equipment prior to going to process areas. Facility staff provided the inspection team with records associated with Subpart O compliance. A list of documents reviewed can be found in Item 10 of this report. The inspection team discussed the medical equipment sterilization process and facility process areas. All process areas of the facility were inspected during the walk-through. The inspection team notified facility staff when photographs were taken during the walkthrough. All photographs are considered Confidential Business Information (CBI) until reviewed by facility staff. The inspection team indicated that a FLIR camera and photoionization detector (PID) would be used during the process walkthrough.
Activity 9. Discussed CBI.
Yes No NA Y
Records Reviewed at the Facility 10. The types of records reviewed, Y
and the time period reviewed.
Facility Walk-Through Observations
Comments
The inspection team indicated that any material claimed to be CBI would be treated in accordance with regulations.
The inspection team reviewed the following records on-site: Records requested during the inspection:
1. Acid-water scrubber operation and maintenance logs
2. Scrubber performance tests 3. EtO usage
Activity
11. The process equipment observed and the associated operational rate observed (e.g., Furnace 1 production rate was 5 lbs/hr on 1/1/15, at 2:00 pm - permit requires max rate at 6 lbs/hr).
Yes No NA Y
Provide the date and time the information was recorded by the inspector.
Identify the permit limit (if applicable).
An attachment may be used for a large amount of information.
Comments
Inspection of process areas began at 10:23 AM EDT. The inspection team observed the staging area for equipment. All equipment arrives to the facility pre-packaged. The equipment is kept on pallets and moved by forklift.
The facility operates one large preconditioning room. The pre-conditioning process consists of raising heat and humidity of the equipment and does not have any associated emissions.
Following pre-conditioning, the equipment is loaded into sterilization chambers. The facility operates four chambers all located in the same room. No emissions were detected by either the FLIR camera or PID.
Following sterilization, the equipment is moved to one of two aeration rooms. One room is kept at ambient conditions (cold) and the other operates at an increased temperature and humidity (hot). The rooms are kept at these conditions to improve removal of residual EtO on equipment.
Following aeration, the equipment is moved to a storage area and is picked up by the customer.
Activity
12. The type of process parametric monitoring observed and the associated value observed (e.g., Furnace 1 flux injection rate was 200 lbs/batch at 1/1/15, at 2:00 pm - permit requires max rate at 225 lbs/batch).
Yes No NA N/A
Provide the date and time the information was recorded by the inspector.
Identify the permit limit (if applicable).
An attachment may be used for
a large amount of information.
13. If process equipment or
N/A
parametric monitoring
equipment was not operating,
state the reason by facility
personnel why the equipment
was not operating.
Comments
Activity
14. The type of air pollution control equipment, the process equipment it is controlling, and the associated parametric monitoring value observed (e.g., baghouse pressure drop, temperature, scrubber flow rate, etc.).
Yes No NA Y
(For example - RTO 1 controlling furnace 1, 1,500 degrees F on 1/1/15, at 2:00 pm - permit requires 1,400 degree F or higher).
Provide the date and time the information was recorded by the inspector.
Identify the permit limit (if applicable).
An attachment may be used for
a large amount of information.
15. Continuous emissions
N/A
monitoring devices and values
observed. (e.g., CEMS, COMs,
etc.).
Provide the date and time the information was recorded by the inspector.
Identify the permit limit (if applicable).
An attachment may be used for
a large amount of information.
16. If air pollution control
N/A
equipment was not operating,
state the reason by facility
personnel why the equipment
was not operating.
Comments
EtO sterilizer chamber and aeration room emissions are captured and routed to separate acid-water scrubbers. The scrubbers have a 99% destruction efficiency. Record review did not indicate any issues with scrubber operation.
Activity
17. Capture and collection system (enclosures and hoods) observations, if applicable (e.g., the magnitude and duration of emission escaping capture from the hood).
18. Ductwork transferring the emissions to the air pollution control device observations, if applicable (e.g., the magnitude and duration of emission escaping from the ductwork, holes or deterioration in ductwork, no deterioration observed, etc.).
19. Any existing unpermitted emission points, new unpermitted emission points, or non-permitted construction activities observed. (if yes, describe in the comments field).
20. Were any visible emissions observed? (if yes, identify the location and equipment).
21. Was a Method 9 reading performed? (if yes, identify the location and equipment).
22. Was the cause of the visible emissions investigated and the information documented?
23. Was a Method 22 performed for visible emissions? (if yes, identify the location and equipment).
24. Identify the cause of the visible emissions as explained by facility personnel, if applicable.
Yes No NA N/A
N/A
N
N N N N N/A
Comments
No visible emissions were observed during the inspection.
Activity
25. Was the infrared camera used? If so, attach the video log (which includes the equipment ID, and the date and time the video was recorded) and videos to this report.
26. Was the TVA used? If so, identify the equipment monitored and the results.
Yes No NA Y
N
Provide the date and time the information was recorded by the inspector. Include actual instrument readings for each piece of equipment monitored above the leak definition and/or where the infrared camera identified a release.
An attachment may be used for
a large amount of information.
27. Was the PID used? If so,
Y
identify how the PID was used
and the results.
Provide the date and time the information was recorded by the inspector.
An attachment may be used for a large amount of information.
Closing Meeting 28. Conducted a closing meeting. Y
29. Summarize any additional
N/A
information needed, if
applicable?
30. Accept a declaration of CBI, if N/A
applicable?
Comments
No emissions were detected with the FLIR camera, and no videos were taken. The FLIR camera was used to take digital photos of process areas. More information can be found in Appendix A of this report.
A PID was used at the facility during the walkthrough. The PID was initially calibrated at 10:08 AM EDT following the opening meeting. During the walk-through, no spikes were noted from the PID in any of the process areas. Prior to leaving the facility, the PID was bump checked again at 11:10 AM EDT to ensure the initial calibration was still valid. The PID passed the bump check.
The Region 4 inspection team conducted a closing meeting on August 15, 2023, at 11:00 AM EDT with Mr. Parzuchowski.
Facility personnel did not declare or claim any documents as CBI, at the time of the inspection or during review of the draft inspection report.
Activity
31. Discussed observations.
32. Discussed next steps, if applicable?
33. Date and time inspection concluded. Miscellaneous
34. Include any additional observations, if applicable.
EPA Investigator/Inspector Signature:
EPA Supervisor Signature & Title:
Yes No NA Y
Y
Y
N/A
Comments
The inspection team thanked facility staff for their time. The team discussed the facility walkthrough. A final inspection report from EPA Region 4 will be sent to the company within a 60-day timeframe. The inspection concluded on August 15, 2023, at 11:12 AM EDT.
Digitally signed by DANIEL
DANIEL SLADE SLADE Date: 2023.09.20 11:20:08 -04'00'
___________________________________
TODD
Digitally signed by TODD
GROENDYKE
G_R__O__E_N__D__Y_K__E_______D_a_te_: 2_0_2_3._09_.2_5_0_8_:0_1:_58_-04'00'
Chief, South Air Enforcement Section
Appendix A Photograph log
During the August 15, 2023, inspection, EPA Region 4 staff used the FLIR GF320 camera to take digital photographs at International Sterilization Laboratory, located in Groveland, Florida. Below is an inventory of the images. All images were taken by EPA inspector Stephen Rieck. All times are in Eastern Daylight Time (EDT).
File Name DC_0101 DC_0102 DC_0103 DC_0104 DC_0105 DC_0106
Time 10:26 AM 10:26 AM 10:28 AM 10:32 AM 10:40 AM 10:41 AM
Image Description Staging Area Sterilization Chambers Pre-conditioning Room Aeration Rooms EtO Storage Area Acid Water Scrubber