AIR EMISSION PERMIT NO IS ISSUED TO

Transcription

1 AIR EMISSION PERMIT NO IS ISSUED TO Quality Sterilization Services Inc th Avenue Northwest Minneapolis, Hennepin County, Minnesota The emission units, control equipment and emission stacks at the stationary source authorized in this permit are as described in the following permit application and subsequent revisions: Permit Type Application Date Total Facility Operating Permit August 1, 1996 This permit authorizes the Permittee to modify and operate the stationary source at the address listed above unless otherwise noted in Table A. The permit action is a non-major modification under 40 CFR due to permit limitiations. The Permittee must comply with all the conditions of the permit and with all general conditions listed in Minn. R. pt , subp. 16, and all standard permit requirements listed in 40 CFR 70.6(a), which are incorporated by reference. Any changes or modifications to the stationary source must be performed in compliance with Minn. R. pts to Terms used in the permit as defined in the state air pollution control rules unless the term is explicitly defined in the permit. Permit Type: Federal ; Part 70; synthetic minor modification under 40 CFR Issue Date: January 19, 1999 Expiration: January 19, 2004 All Title I Conditions do not expire. Ann Foss for Michael J. Sandusky Division Manager Air Quality Division TRW:yma for Lisa J. Thorvig Acting Commissioner Minnesota Pollution Control Agency TDD (for hearing and speech impaired only): (612) Printed on recycled paper containing at least 10% fibers from paper recycled by consumers

2 DRAFT Permit No Page 2 TABLE OF CONTENTS Notice to the Permittee Permit Shield Facility Description Table A: Limits and Other Requirements Table B: Submittals

3 DRAFT Permit No Page 3 NOTICE TO THE PERMITTEE: Your stationary source may be subject to the requirements of the Minnesota Pollution Control Agency s (MPCA) solid waste, hazardous waste, and water quality programs. If you wish to obtain information on these programs, including information on obtaining any required permits, please contact the MPCA general information number at: Metro Area (651) Outside Metro Area TTY (651) The rules governing these programs are contained in Minn. R. chs Written questions may be sent to: Minnesota Pollution Control Agency, 520 Lafayette Road North, St. Paul, Minnesota Questions about this air emission permit or about air quality requirements can also be directed to the telephone numbers and address listed above. PERMIT SHIELD: Subject to the limitations in Minn. R , compliance with the conditions of this permit shall be deemed compliance with the specific provision of the applicable requirement identified in the permit as the basis of each condition. Any requirements which have been determined not to apply are listed in Table A of this permit. The permit shield, however does not apply to: Minn. R. ch (Noise Pollution Control).

4 DRAFT Permit No Page 4 FACILITY DESCRIPTION: Quality Sterilization Services, Inc. provides contract sterilization services for medical devices, pharmaceuticals and cosmetics. The company has been in business since The facility currently consists of six sterilization chambers along with a number of aeration rooms and conditioning rooms. The Permittee proposes to add 6 new sterilization chambers within the next few years. The sterilization process is a batch process that begins with a conditioning period conducted in a conditioning room where the heat and humidity are controlled. After the products are transferred to a sterilization chamber, there is the introduction of steam, introduction of nitrogen, introduction of ethylene oxide (EtO), an exposure period, and then nitrogen and air washes to remove the residual EtO. The main operating parameters during sterilization are: temperature, humidity, and EtO concentration (partial pressure). Next the sterilization chamber door is opened so that the product can be unloaded. Opening the chamber door automatically triggers the rear exhaust valve to open and air to be drawn through the chamber. The rear exhaust blower serves to reduce worker exposure to EtO. The last step is transferring the sterilized product to one of the aeration rooms where any residual EtO left in the sterilized material can diffuse out. The main pollutant of concern at this facility is EtO. EtO is a listed hazardous air pollutant. Facilities of this type are subject to 40 CFR pt. 63, subp. O - Ethylene Oxide Emission Standards for Sterilization Facilities. The EtO will be controlled by a catalytic oxidizer which has a rated destruction efficiency of about 99 percent.

5 TABLE A: LIMITS AND OTHER REQUIREMENTS 01/19/99 Facility Name: Quality Sterilization Services Inc Permit Number: Table A contains limits and other requirements with which your facility must comply. The limits are located in the first column of the table (What To do). The limits can be emission limits or operational limits. This column also contains the actions that you must take and the records you must keep to show that you are complying with the limits. The second column of Table A (Why to do it) lists the regulatory basis for these limits. Appendices included as conditions of your permit are listed in Table A under total facility requirements. Subject Item: Total Facility What to do Operation and Maintenance Plan: Submit an Operation and Maintenance (O&M) Plan to the Compliance Tracking Coordinator for all air pollution control equipment within 60 days of permit issuance for review and approval. Once approved, retain the Plan at the facility. Why to do it Minn. R , subp. 14 and Minn. R , subp. 16(J) Include in the Plan the procedures to be implemeted, and parameters to be monitored, that will be used together to determine if the control equipment is operating properly. Also include in the Plan the corrective actions to be taken if the monitored parameters are out of their normal operating ranges. The Plan shall also include inspection forms to be used during daily and quarterly incinerator inspections Performance Testing: Conduct all performance tests in accordance with Minn. R. Minn. R. ch ch unless otherwise noted in Tables A, B, and/or C. Monitoring Equipment: Install or make needed repairs to monitoring equipment Minn. R , subp. 4(D) within 60 days of issuance of the permit if monitoring equipment is not installed and operational on the date the permit is issued. Monitoring Equipment Calibration: Annually calibrate all required monitoring Minn. R , subp. 4(D) equipment (any requirements applying to continuous emission monitors are listed separately in this permit). Operation of Monitoring Equipment: Unless otherwise noted in Tables A, B, and/or Minn. R , subp. 4(D) C, monitoring a process, or control equipment connected to that process, is not necessary during periods when the process is shutdown, or during checks of the monitoring systems, such as calibration checks and zero and span adjustments. If monitoring records are required, they should reflect any such periods of process shutdown or checks of the monitoring system. Circumvention: Do not install or use a device or means that conceals or dilutes Minn. R emissions, which would otherwise violate a federal or state air pollution control rule, without reducing the total amount of pollutant emitted. Shutdowns: Notify the Commissioner at least 24 hours in advance of a planned Minn. R , subp. 3 shutdown of any process or control equipment if the shutdown would cause an increase in the emissions of any regulated air pollutant. At the time of notification, notify the Commissioner of the cause of the shutdown and the estimated duration. Notify the Commissioner again when the shutdown is over. Breakdowns: Notify the Commissioner within 24 hours of a breakdown of more Minn. R , subp. 2 than one hour duration of any process or control equipment if the breakdown causes an increase in the emissions of any regulated air pollutant. At the time of notification or as soon thereafter as possible, the permittee shall also notify the Commissioner of the cause of the breakdown and the estimated duration. Notify the Commissioner again when the breakdown is over. Notification of Deviations Endangering Human Health or the Environment: As soon Minn. R , subp. 1 as possible after discovery, notify the Commissioner or the state duty officer, either orally or by facsimile, of any deviation from permit conditions which could endanger human health or the environment. Notification of Deviations Endangering Human Health or the Environment Report: Minn. R , subp. 1 Within 2 working days of discovery, notify the Commissioner in writing of any deviation from permit conditions which could endanger human health or the environment. Include the following information in this written description: 1. the cause of the deviation; 2. the exact dates of the period of the deviation, if the deviation has been corrected; 3. whether or not the deviation has been corrected; 4. the anticipated time by which the deviation is expected to be corrected, if not yet corrected; and 5. steps taken or planned to reduce, eliminate, and prevent reoccurrence of the deviation. Air Pollution Control Equipment: Operate all pollution control equipment whenever the corresponding process equipment and emission units are operated, unless otherwise noted in Table A. Application for Permit Amendment: If a permit amendment is needed, submit an application in accordance with the requirements of Minn. R through Minn. R Submittal dates vary, depending on the type of amendment needed. Review the revisions to 40 CFR pt. 63, subp. O when available, and submit a permit amendment (if necessary). Minn. R , subp. 2; Minn. R , subp. 16(J) Minn. R through Minn. R A-1

6 TABLE A: LIMITS AND OTHER REQUIREMENTS 01/19/99 Facility Name: Quality Sterilization Services Inc Permit Number: Extension Requests: The Permittee may apply for an Administrative Amendment Minn. R , subp. 1(H) to extend a deadline in a permit by no more than 120 days, provided the proposed deadline extension meets the requirements of Minn. R , subp. 1(H). Recordkeeping: Maintain records describing any insignificant modifications (as Minn. R , subp. 5(B) required by Minn. R , subp. 3) or changes contravening permit terms (as required by Minn. R subp. 2), including records of the emissions resulting from those changes. Recordkeeping: Retain all records at the stationary source for a period of five (5) Minn. R , subp. 5(C) years from the date of monitoring, sample, measurement, or report. Records which must be retained at this location include all calibration and maintenance records, all original strip-chart recordings for continuous monitoring instrumentation, and copies of all reports required by the permit. Records must conform to the requirements listed in Minn. R , subp. 5(A). Noise: The Permittee shall comply with the noise standards set forth in Minn. R. Minn. R to at all times during the operation of any emission units. This is a state only requirement and is not federally enforceable. The Permittee shall comply with the General Conditions listed in Minn. R. Minn. R , subp , subp. 16. Inspections: Upon presentation of credentials and other documents as may be Minn. R , subp. 9(A) required by law, allow the Agency, or its representative, to enter the Permittee's premises to have access to and copy any records required by this permit, to inspect at reasonable times (which include any time the source is operating) any facilities, equipment, practices or operations, and to sample or monitor any substances or parameters at any location. Emission Fees: due 60 days after receipt of an MPCA bill. Minn. R through Minn. R Risk Management Plan: The Permittee may be required to submit a Risk 40 CFR Part 68 Management Plan (RMP) under the federal rule, 40 CFR Part 68 which was promulgated on June 20, The rule will require each owner or operator of a stationary source, at which a regulated substance is present above a threshold quantity in a process, to design and implement an accidental release prevention program. The RMPs must be submitted to a centralized location as specified by US EPA. The Permittee may obtain the RMP submittal information at or by calling These requirements must be complied with no later than the latest of the following dates: (1) June 21, 1999; (2) Three years after the date on which a regulated substance is first listed under 40 CFR Section ; or (3) The date on which a regulated substance is first present above a threshold quantity in a process. 40 CFR 63 RECORDKEEPING/REPORTING hdr Any equipment added (or a process change) to an affected source that is within the scope of the definition of affected source under 40 CFR pt. 63, subp. O, and is not defined as reconstruction, shall be considered part of the affected source and subject to all provisions of the relevant standard established for the affected source. The Permittee may not construct a new affected major source or reconstruct an affected source without obtaining written approval from the Administrator according to the procedures specified in Sec (b)(3); Sec. 63.5(d)(3) through (4); and Sec 63.5(e). The Permittee shall submit an application for approval prior to the construction or reconstruction of an affected source. A separate application shall be submitted for each construction or reconstruction and should be submitted well in advance of the date construction or reconstruction is planned to commence. Each application shall contain a minimum of the following information: 1. The applicant's name and address; 2. A notification of intention to construct or reconstruct an affected source; 3. The address or proposed address of the source; 4. An identification of the relevant standard that is the basis of the application; 5. The expected commencement and completion date of the construction or reconstruction; 6. The anticipated date of startup of an affected source; and 7. The type and quantity of hazardous air pollutants emitted by the source, including the information used to determine the amount to the extent that they demonstrate performance and compliance. 8. Other relevant technical information on the emission unit and pollution control equipment as stated in Sec (b)(3)(ii) - "Application for approval of construction"; Sec (c)(3); and Sec. 63.5(d)(3). 40 CFR Section 63.5(b)(6); Minn. R CFR Section (b)(2); Minn. R CFR Section (b)(3); Minn. R CFR Section (b)(3)(i)(B); Minn. R A-2

7 TABLE A: LIMITS AND OTHER REQUIREMENTS 01/19/99 Facility Name: Quality Sterilization Services Inc Permit Number: Subject Item: Associated Items: GP 001 Sterilization System Components CE 001 Catalytic Afterburner w/heat Exchanger EU pallet sterilizer (A) EU pallet sterilizer (B) EU pallet sterilizer (A) EU pallet sterilizer EU pallet sterilizer (A) EU pallet sterilizer EU pallet sterilizer (B) EU pallet sterilizer (A) EU pallet sterilizer (B) EU pallet sterilizer (C) EU pallet sterilizer (C) EU pallet sterilizer (B) EU 013 Aeration Room 1 SV 001 What to do Preauthorized Construction: the permittee is preauthorized to add six (6) new sterilizers to the facility of the following sizes: three (3) - 12 pallet, one (1) - 9 pallet, one (1) - 3 pallet, and one (1) - 2 pallet. This construciton authorization expires five (5) years after the date of permit issuance. EMISSION LIMITS Ethylene oxide: greater than or equal to 99 percent destruction efficiency from each sterilization chamber vent, except during periods of malfunction. Ethylene oxide: greater than or equal to 99 percent destruction efficiency or reduced to a concentration of 1 ppmv, whichever is less stringent, from each aeration room vent. This emission limitation does not apply during periods of malfunction. POLLUTION CONTROL EQUIPMENT REQUIREMENTS Why to do it Minn. R , subp. 2 hdr 40 CFR Section (b); 40 CFR Section (c); Minn. R ; Minn. R CFR Section (b); 40 CFR Section (d); Minn. R ; Minn. R hdr Sterilizers and aeration rooms will be used only when the oxidizer is operational. Minn. R , subp. 2; Minn. R , subp. 16(J) Pressure Drop (daily): once each day during normal operation the permittee shall complete an daily inspection form for the oxidizer to determine if the operating conditions are typical of normal operating conditions. This form shall include the pressure drop across the catalyst bed. If any of the monitored parameters are out of the normal operating range, the permittee shall follow the corrective actions in the O&M Plan. The forms are to be kept with the permanent record on-site. Temperature Rise (monthly): once each month during normal operation record the temperature rise across the oxidizer while a common sterilizer load is exhausted by itself. If it is determined that the catalyst activity has been impaired, by comparision of the observed temperature rise to the past temperature rise records, the permittee shall follow the corrective actions in the facility O&M Plan. The temperature rise records are to be kept with the permanent record on-site. Inspection (quarterly): once per quarter complete the quarterly inspection form following inspection of internal and external system components including refractory, heat exchangers, and electrical systems. If a problem is found during the inspection, follow the corrective actions in the facility O&M Plan. The form shall be retained on-site as part of the permanent record. Efficiency Test (annually): once each 12 month period conduct an efficiency test where the concentration of EtO is measured at the inlet and the outlet to the oxidizer to determine the destruction efficiency. If the test results show a destruction efficiency of less than 99 percent, follow the corrective actions in the O&M Plan. Oxidation Temperature: following completion of the performance test, operation of the catalytic oxidizer with the oxidation temperature, averaged over three hours, more than 10 degrees F (5.6 degrees C) below the baseline temperature shall constitute a violation of the sterilization chamber vent standard. The temperature will be determined at the catalyst bed inlet. Minn. R , subp. 2; Minn. R , subp. 14; Minn. R , subp. 16(J); Minn. R , subp. 4 Minn. R , subp. 2; Minn. R , subp. 14; Minn. R , subp. 16(J); Minn. R , subp. 4 Minn. R , subp. 2; Minn. R , subp. 14; Minn. R , subp. 16(J); Minn. R , subp. 4 Minn. R , subp. 2; Minn. R , subp. 14; Minn. R , subp. 16(J); Minn. R , subp CFR Section (b)(2)(ii); Minn. R ; Minn. R A-3

8 TABLE A: LIMITS AND OTHER REQUIREMENTS 01/19/99 Facility Name: Quality Sterilization Services Inc Permit Number: Oxidation Temperature: following completion of the performance test, operation of the catalytic oxidizer with the oxidation temperature, averaged over three hours, more than 10 degrees F (5.6 degreesc) below the baseline temperature shall constitute a violation of the aeration room vent standard. The temperature will be determined at the catalyst bed inlet. TESTING REQUIREMENTS 40 CFR Section (c)(3)(ii); Minn. R ; Minn. R hdr Initial Performance Test: due 180 days after Initial Startup of the Catalytic Oxidizer. (Compliance date is December 6, 1998). The testing is to be completed on the sterilization chamber vent to determine compliance with the emission standard at 40 CFR (c) and shall be conducted according to the methods and procedures at 40 CFR Initial Performance Test: due 180 days after Initial Startup of the Catalytic Oxidizer. (Compliance date is December 6, 1999). The testing is to be completed on the aeration room vent to determine compliance with the emission standard at 40 CFR (d) and shall be conducted according to the methods and procedures at 40 CFR Establishing Operating Parameters: during the performance test on the sterilization chamber vent, the Permittee shall establish as a site-specific operating parameter the baseline temperature during the performance test required in 40 CFR (b)(2) using the procedures described in 40 CFR (f)(1). Establishing Operating Parameters: during the performance test on the aeration room vent, the Permittee shall establish as a site-specific operating parameter the baseline temperature using the procedures described in 40 CFR (f)(2) Methods and Procedures: during the performance test on the sterilization chamber vent, the Permittee shall determine the percent reduction efficiency of the catalytic oxidizer used to comply with 40 CFR (c) using the test methods and procedures in 40 CFR (b)(1). Methods and Procedures: during the performance test on the aeration room vent, the Permittee shall determine the percent reduction efficiency of the catalytic oxidizer used to comply with 40 CFR (d) using the test methods and procedures in 40 CFR (d)(1). 40 CFR Section 63.7(a); Minn. R ; Minn. R CFR Section 63.7(a); Minn. R ; Minn. R CFR Section (b)(1)(ii); Minn. R ; Minn. R CFR Section (c)(2); Minn. R ; Minn. R CFR Section (b)(1); Minn. R ; Minn. R CFR Section (c)(1)(ii); Minn. R ; Minn. R Performance Test Pre-test Meeting: due 7 days before Initial Performance Test Minn. R , subp. 4 MONITORING REQUIREMENTS hdr Monitoring Requirements: All monitoring equipment shall be installed such that representative measurements of emissions or process parameters from the source are obtained. For monitoring equipment purchased from a vendor, verification of the operational status of the monitoring equipment shall include completion of the manufacturer's written specifications or recommendations for installation, operation, and calibration of the system. Monitoring Requirements: Continuously monitor and record the oxidation temperature using the temperature monitor described in paragraph (c)(4) of this section (i.e. 40 CFR (c)(4)). 40 CFR Section (a)(2); Minn. R ; Minn. R ; Minn. R , subp CFR Section (c); Minn. R ; Minn. R ; Minn. R , subp. 4 Record the average oxidizer temperature, averaged over 3 hours, as measured at the catalyst bed inlet and outlet. Monitoring Requirements: For all vents, a data acquisition system for the temperature monitor shall compute and record an average oxidation temperature each hour and a 3-hour block average every third hour. Monitoring Requirements: Install, calibrate, operate, and maintain a temperature monitoring and recording system accurate to within plus or minus 10 degrees Fahrenheit to measure the oxidation temperature. Verify the accuracy of the temperature monitor twice each calendar year (once in each calendar half-year) with a reference temperature monitor (traceable to National Institute of Standards and Technology (NIST) standards or an independent temperature measurement device dedicated for this purpose). During accuracy checking, the probe of the reference device shall be at the same location as that of the temperature monitor being tested. Monitoring Requirements: Continuous Monitoring System (CMS) shall be installed operational, and the data verified in conjunction with conducting the performance test required under 40CFR Verification of operational status shall, at a minumum, include completion of the manufacturer's written specifications or recommendations for installation, operation, and calibration of the system. 40 CFR Section (c); Minn. R ; Minn. R ; Minn. R , subp CFR Section (c)(4); Minn. R ; Minn. R ; Minn. R , subp CFR Section 63.8(c)(3); Minn. R ; Minn. R ; Minn. R , subp. 4 A-4

9 TABLE A: LIMITS AND OTHER REQUIREMENTS 01/19/99 Facility Name: Quality Sterilization Services Inc Permit Number: Monitoring Requirements: Develop and implement a CMS quality control program which includes, at a minimum, a written protocol that describes procedures for each of the following operations: 40 CFR Section 63.8(d); Minn. R ; Minn. R ; Minn. R , subp. 4 (i) Initial and any subsequent calibration of the CMS; (ii) Determination and adjustment of the calibration drift of the CMS; (iii) Preventive maintenance of the CMS, including spare parts inventory; (iv) Data recording, calculations, and reporting; (v) Accuracy audit procedures, including sampling and analysis methods; and (vi) Program of corrective action for a malfucntioning CMS. Monitoring Requirements: Notify the commissioner in writing of the planned date of the performance evaluation simultaneously with the notification of the performance test date required under 40 CFR 63.7(b). Monitoring Requirements: Conduct a performance evaluation of the temperature monitor during the performance test required under 40 CFR Monitoring Requirements: Submit a written copy of the results of the performance evaluation to the commissioner simultaneously with the results of the performance test required under 40 CFR RECORDKEEPING/REPORTING REQUIREMENTS Recordkeeping Requirements: Maintain a file of all information required by 40 CFR 63.10(b)(2) and 63.10(c) (as specified in 40 CFR , Table 1) that is recorded in a form suitable and readily available for expeditious inspection and review. The files shall be retained for at least 5 years following the date of each occurence, measurement, maintenance, corrective action, report, or record. At a minimum, the most recent 2 years of data shall be kept on site. 40 CFR Section 63.8(e)(2); Minn. R ; Minn. R ; Minn. R , subp CFR Section 63.8(e)(4); Minn. R ; Minn. R ; Minn. R , subp CFR Section 63.8(e)(5); 40 CFR 63.10(e)(2); Minn. R ; Minn. R ; Minn. R , subp. 4 hdr 40 CFR Section 63.10(b) and (c); Minn. R ; Minn. R ; Minn. R , subp. 5 A-5

10 TABLE B: SUBMITTALS Facility Name: Quality Sterilization Services Inc Permit Number: /19/99 Table B lists most of the submittals required by this permit. Please note that some submittal requirements may appear in Table A or, if applicable, within a compliance schedule located in Table C. Table B is divided into two sections in order to separately list one-time only and recurrent submittal requirements. Each submittal must be postmarked or received by the date specified in the applicable Table. Those submittals required by parts to must be certified by a responsible official, defined in Minn. R , subp. 21. Other submittals shall be certified as appropriate if certification is required by an applicable rule or permit condition. Send any application for a permit or permit amendment to: Permit Technical Advisor Permit Section Air Quality Division Minnesota Pollution Control Agency 520 Lafayette Road North St. Paul, Minnesota Also, where required by an applicable rule or permit condition, send to the Permit Technical Advisor notices of: - accumulated insignificant activities, - installation of control equipment, - replacement of an emissions unit, and - changes that contravene a permit term. Unless another person is identified in the applicable Table, send all other submittals to: Supervisor Compliance Determination Unit Air Quality Division Minnesota Pollution Control Agency 520 Lafayette Road North St. Paul, Minnesota Send submittals that are required to be submitted to the U.S. EPA regional office to: Mr. George Czerniak Air and Radiation Branch EPA Region V 77 West Jackson Boulevard Chicago, Illinois B-1

11 TABLE B: ONE TIME SUBMITTALS OR NOTIFICATIONS Facility Name: Quality Sterilization Services Inc 01/19/99 Permit Number: What to send When to send Portion of Facility Affected Application for Permit Reissuance due 180 days before expiration of Existing Total Facility Permit Notification of the Actual Date of Initial Startup due 15 days after Initial Startup. The date GP001, Total Facility shall be either a postmarked date or a delivered date and refers specifically to the catalytic oxidizer. Performance Test Notification (written) due 60 days before Initial Performance Test GP001 Performance Test Plan due 60 days before Initial Performance Test GP001 Performance Test Report - Microfiche Copy due 105 days after Initial Performance Test GP001 Performance Test Report due 60 days after Initial Performance Test GP001 B-2

12 TABLE B: RECURRENT SUBMITTALS Facility Name: Quality Sterilization Services Inc 01/19/99 Permit Number: What to send When to send Portion of Facility Affected Semiannual Deviations Report due 30 days after end of each calendar Total Facility half-year following Permit Issuance. The first semiannual report submitted by the Permittee shall cover the calendar half-year in which the permit is issued. The first report of each calendar year covers January 1 - June 30. The second report of each calendar year covers July 1 - December 31. If no deviations have occured, the Permitee shall submit the report stating no deviations. Also include all periods of control equipment bypass in this report. Compliance Certification due 31 days after end of each calendar year Total Facility following Permit Issuance (for the previous calendar year). The report covers all deviations experienced during the calendar year. To be submitted to the Commissioner and the U.S. EPA regional office on a form approved by the Commissioner. The EPA regional office contact is: Mr. George Czerniak, Air and Radiation Branch, EPA Region V, 77 West Jackson Boulevard, Chicago, Illinois Emissions Inventory Report due 91 days after end of each calendar year following Permit Issuance (April 1). To be submitted on a form approved by the Commissioner. Total Facility B-3

13 TECHNICAL SUPPORT DOCUMENT For AIR EMISSION PERMIT NO This Technical Support Document (TSD) is for all the interested parties of the permit. The purpose of this document is to set forth the legal and factual basis for the permit conditions, including references to the applicable statutory or regulatory provisions. 1. General Information 1.1. Applicant and Stationary Source Location: Owner and Operator Address and Phone Number Mr. Duane Hass Quality Sterilization Services, Inc Springbrook Drive, Suite 155 Minneapolis, Minnesota (612) Facility Address (SIC Code: 8099) th Avenue Northwest Minneapolis, Minnesota Anoka County 1.2 Description of the facility Quality Sterilization Services, Inc. (QSS) provides contract sterilization services for medical devices, pharmaceuticals and cosmetics. The company has been in business since The facility currently consists of six sterilization chambers along with a number of aeration rooms and conditioning rooms. The Permittee proposes to add 6 new sterilization chambers within the next few years. The sterilization process is a batch process that begins with a conditioning period conducted in a conditioning room where the heat and humidity are controlled. After the products are transferred to a sterilization chamber, there is the introduction of steam, introduction of nitrogen, introduction of ethylene oxide (EtO), an exposure period, and then nitrogen and air washes to remove the residual EtO. The main operating parameters during sterilization are: temperature, humidity, and EtO concentration (partial pressure). Next the sterilization chamber door is opened so that the product can be unloaded. Opening the chamber door automatically triggers the rear exhaust valve to open and air to be drawn through the chamber. The rear exhaust blower serves to reduce worker exposure to EtO. The last step is transferring the sterilized product to one of the aeration rooms where any residual EtO left in the sterilized material can diffuse out. Page 1

14 The main pollutant of concern at this facility is EtO. EtO is a listed hazardous air pollutant. Facilities of this type are subject to 40 CFR pt. 63, subp. O - Ethylene Oxide Emission Standards for Sterilization Facilities. The applicability of 40 CFR pt. 63, subp. O requires that the facility be issued a Part 70 permit. The EtO at this facility is collected at many different points and ultimately routed through a catalytic oxidizer. The high concentration exhaust from the sterilization chamber vacuum pumps is expected to comprise 95 percent of the total EtO used at the facility. This stream has a EtO destruction efficiency of 99.9 percent. The EtO from the rear exhaust blowers and the aeration rooms is a low concentration stream and thought to be about 5 percent of the total EtO used at the facility. The EtO destruction efficiency for this stream is 99 percent. EtO emitted during the transfer of the sterilized products from the sterilization chamber down the hall to the aeration rooms is not routed through the oxidizer. The facility has a gas chromatograph that it uses to monitor concentrations of EtO at sixteen points throughout the facility on a 30 minute basis. The employees also wear badges to measure exposure. The facility also has two small boilers and an emergency generator which all qualify as insignificant activities (Minn. R , subp. 4). 1.3 Description of any changes allowed with this permit issuance The changes authorized with this permit are the addition of the catalytic oxidizer and the addition of six sterilization chambers. 1.4 Description of all amendments issued since the issuance of the last total facility permit and to be included in the Part 70 Permit. No previous air emission permits Facility Emissions: Table 1. Total Facility Potential to Emit Summary: PM PM 10 SO 2 NOx CO VOC Pb Single HAP* Total Facility Limited Potential Emissions Total Facility Actual Emissions * the HAP of concern at this facility is ethylene oxide All HAP Page 2

15 Table 2. Facility and Permit Classification Classification (put x in appropriate box) Major/Affected Source *Synthetic Minor *Minor PSD X NAA X Part 70 Permit Program (Ethylene Oxide) X * Refers to potential emissions that are less than those specified as major by 40 CFR 52.21, 40 CFR pt. 51 Appendix S, and 40 CFR pt Regulatory and/or Statutory Basis Summary of the Regulatory and/or Statutory Basis of all Emission and/or Operational Limits Regulatory Overview of Facility *EU, GP, or SV No. Applicable Regulations Comments: GP CFR pt. 63, subp. O Ethylene Oxide Emission Standards for Sterilization Facilities * Insert the number that identifies the level the limit was set on. 3. Technical Information The drafting of this permit revolved around the application of 40 CFR 63, subp. O - Ethylene Oxide Emission Standards for Sterilization Facilities to Quality Sterilization Services, Inc. (QSS). The Standard was either totally or partially suspended while the permit for the facility was being written. The original compliance deadline for the standard was December 6, After work began on this permit in the later half of 1997 the compliance date was extended for a full year. In early August of 1998, U.S. Environmental Protection Agency (EPA) decided to suspend the compliance date for the aeration room and the chamber exhaust vents for another year. QSS chose to connect its aeration room vents to their catalytic oxidizer, but wait another year on their chamber exhaust vents. The permit team used the existing standard as a guide in drafting this permit, with the understanding that the Permittee would reevaluate this permit after the standard is finalized and submit any necessary permit amendment application. Overall, the permit team found the standard very confusing. In general, the standard separates the vents at the facility into three types: sterilization chamber, aeration room and chamber exhaust (rear exhaust). A separate performance test on each type of vent is prescribed to determine the baseline temperature at which the oxidizer can demonstrate that it can meet the applicable emission limit (depending on the vent type, 99 percent destruction efficiency and/or a maximum concentration of 1 ppmv whichever is less stringent). An exception to this is that the chamber exhaust vent does not have separate requirements if it is manifolded to a control device used to satisfy the requirements of one the other two vents. Page 3

16 Besides the separate testing requirements, the three different types of vents have different averaging times which are used as the basis to calculate average operating temperatures for the oxidizer (again, the chamber exhaust vent does not have separate requirements if it is manifolded to a control device used to satisfy the requirements of one of the other two vents). The average operating temperatures for each vent type are then compared to their corresponding baseline temperatures (which were determined during their respective performance tests). The sterilization chamber vent is based on 3 cycle averages while the aeration room vent is based on 3 hour averages. At this facility all EtO emissions are manifolded to one oxidizer. While it is possible to isolate one of each type of vent for the purpose of conducting a performance test, this is not the way the facility operates. The facility exhausts many different types of vents to the oxidizer at one time. Determining compliance with the standard when more than one type of vent is exhausted simultaneously to the oxidizer puzzled the permit team. This concern was brought to the attention of the Region V contact for this MACT, Margaret Sieffert, and the author David Markwordt on January 7, Mr. Markwordt said he was aware of this problem and the EPA was working on finding a solution. In the meantime, he suggested that we do whatever we thought made the most sense. When asked about the magnitude of the potential changes to the MACT he anticipated that only the monitoring requirements would likely be changed. The permit team attempted to eliminate some of the confusion by having only one averaging time for all testing, monitoring, and compliance purposes. Specifically the averaging time for all types of vents would be based on a three hour average. Since a typical sterilization cycle at QSS is 10 hours long, three cycles would be equal to 30 hours. The team chose to use the 3 hour averaging time, instead of the 30 hour, because it was the conservative approach. Another potentially confusing part of the MACT standard is the fact that after the performance tests at this facility, the oxidizer will have two different baseline temperatures to comply with (one from the sterilization chamber vent test and one from the aeration room vent test). While at first glance this may sound confusing, since many types of vents are exhausted simultaneously to the oxidizer, compliance with the highest of the two baseline temperatures will automatically ensure compliance with the lower. This is true because the standard requires the temperature in the oxidizer to be no lower than 10 degrees Fahrenheit below each baseline temperature. David Markwordt was contacted again on May 19, 1998, to inquire about the status of the revisions to the standard. Mr. Markwordt stated that he was unsure as to how much additional time it would take for the standard to be finished. When asked how this uncertainty should be addressed from a permitting perspective he suggested we contact Gil Wood with EPA enforcement. Mr. Wood suggested we put a condition in the permit that the final standard supersede the permit. The permit team, in consultation with the Attorney General s office, thought that approach produced a vague permit. As an alternative we decided to include a requirement for the Permittee to review their permit in light of the revised standard, when it is finalized, and submit an amendment (if necessary). Page 4

17 Beyond what was included in the MACT standard, the team was also concerned about the activity of the catalyst. If the catalyst were to become inactivated, EtO would move through the oxidizer and not be destroyed. The prescribed monitoring of the baseline temperature would not indicate the onset of this catalyst problem. To remedy this, the temperature rise across the catalyst bed will be monitored while a common EtO load is evacuated. A significant drop in the temperature rise, compared to the previously recorded temperature rises, would indicate the need for some type of further investigation. Annually QSS will be required to conduct efficiency testing where the concentration of EtO will be measured at the inlet and at the outlet to the oxidizer to determine the destruction efficiency of the unit. Also, QSS will be required to conduct daily and quarterly inspections to determine if the observed oxidizer operating conditions are typical of normal conditions. MPCA has examples of forms from the EPA Operation and Maintenance Guidelines for Air Pollution Control Equipment manual that QSS may use as a guide in developing their own form. Six new sterilizers are authorized with this permit. The addition of more sterilizers at the facility will not trigger 40 CFR pt. 63 notification requirements in the future unless the number of new sterilizers added at one time is large enough that the action would be considered a reconstruction. Individual new sterilizers would be within the scope of the definition of affected source for 40 CFR pt. 63, subp O and as such are considered part of the affected source and subject to the provisions of the standard (40 CFR 63.5(b)(6)). A permit amendment would not be necessary for this action since the addition of six sterilizers is preauthorized in the permit. 4. Conclusion No comments were received during the public notice period. Based on the information provided by Quality Sterilization Services, Inc., the MPCA has reasonable assurance that the proposed operation of the emission facility, as described in the Air Emission Permit No and this TSD, will not cause or contribute to a violation of applicable federal regulations and Minnesota Rules. Staff Members on Permit Team: Trent Wickman, Greg Kvaal, Rhonda Land, Dave Vaaler, Steve Sommer, OnSoon Berglund Attachment: Facility emissions summary Page 5