Document 9JEgv996MQRjgYwLyjK3XEbRR

Report Title: Inspection Date(s): Regulatory Program(s): Company Name: Facility Name: Facility Location: Latitude: County/Parish: AFS/ICIS-Air Number: Permit Number: NAICS Code: DSB ID #: Clean Air Act Inspection of Adare Pharma Solutions 12/10/2024 SIP, MACT, NSPS Adare Pharma Solutions, LLC Adare Pharma Solutions 1100 Orthodox St Philadelphia, PA 19124 40.01863 Longitude: Philadelphia County -75.09271 PAPAM0004210102258 P18-000013 325412, 446110 SIC: ECAD-5688 2834, 5122 Facility Representatives: Tyrone Hart, EHS Manager Phone: 215-807-1015 Email: Vivek Thapar, Director of Engineering Phone: 262-685-6262 Email: Shawn Watson, VP of Quality Phone: 215-807-1324 Email: Point of Contact Tyrone.Hart@adareps.com Vivek.Thapar@adareps.com shawn.watson@adareps.com EPA Inspectors: Scott Yanos, Compliance Officer Phone: 215-814-2128 Email: Yanos.Scott@epa.gov Parmatma Adhikari, Compliance Officer Phone: 215-814-2161 Email: Adhikari.Parmatma@epa.gov State/Local Inspectors: Duaa Saleh, Environmental Engineer, AMS Philadelphia Phone: 215-685-7575 Email: Duaa.Saleh@phila.gov Johana Borda-Perez Phone: Not provided Email: Johana.Borda-Perez@Phila.gov DSB ID #: ECAD-5688 EPA Lead Inspector Signature Supervisor Signature SCOTT YANOS Digitally signed by SCOTT YANOS Date: 2025.01.22 08:56:41 -05'00' Scott Yanos 1600 John F Kennedy Blvd Philadelphia, PA 19103-2852 KRISTEN HALL Digitally signed by KRISTEN HALL Date: 2025.01.22 10:06:01 -05'00' Kristen Hall Date Date 2 DSB ID #: ECAD-5688 Table of Contents I. Introduction ............................................................................................................................... 4 A. Summary of the Facility......................................................................................................... 4 B. Inspection Opening Conference............................................................................................ 4 II. Site Activity/Process Description .............................................................................................. 5 III. Observations ............................................................................................................................ 6 IV. Records Review ........................................................................................................................ 7 V. Closing Conference ................................................................................................................... 9 VI. List of Attachments ............................................................................................................ 10 3 DSB ID #: ECAD-5688 I. Introduction The United States Environmental Protection Agency (EPA) conducted a Clean Air Act (CAA) inspection at Adare Pharma Solutions (Adare or Facility) to verify compliance with applicable State and Federal regulations. The Air Management Services of Philadelphia (AMS) was notified of the inspection on November 4, 2024 via email. On December 9, 2024, EPA notified the Facility of the planned inspection via phone and email. EPA emailed a list of records for review to Tyrone Hart, EHS Manager, prior to the inspection (see Attachment 1). These records are listed in the Records Review section of the report. The inspection included an evaluation of the Facility's processes and its compliance with the CAA. All information included in this report is the result of statements by the Facility representatives, materials shown to the inspectors by the Facility representatives, and/or documents provided by the Facility representatives to the inspectors at the time of, or subsequent to, the inspection. In addition, information gathered prior to the inspection from a review of EPA and State records may be included in this report. A. Summary of the Facility The Facility is located at 1100 Orthodox St, Philadelphia, PA 19124. Adare Pharma Solutions is a smallscale pharmaceutical manufacturing facility. The facility focuses on producing tablets and capsules for various clients. The Facility received a Synthetic Minor Permit (OP18-000013) from Philadelphia AMS issued on November 17, 2020. Adare Pharma Solutions is classified as a synthetic minor source (SM-80) for Volatile Organic Compound (VOC), and Hazardous Air Pollutant (HAP). The Facility is subject to, or potentially subject to the following federal regulations: 40 CFR Part 60 Subpart Dc - Standards of Performance for Small Industrial-CommercialInstitutional Steam Generating Units 40 CFR Part 63 Subpart ZZZZ - National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines B. Inspection Opening Conference At 09:07 AM on December 10, 2024, EPA inspectors arrived at the Facility for a CAA Inspection and conducted a brief opening conference. Adare Pharma Solutions was represented by Vivek Thapar, Director of Engineering; Tyrone Hart, Environment and Health Safety Manager; and Shawn Watson, Vice President of Quality. Also, Duaa Saleh, Environmental Engineer and Johana Borda-Peres, Specialist Engineer (AMS) were present. EPA inspectors, Scott Yanos and Parmatma Adhikari, presented their credentials and explained the purpose of the visit was to conduct a CAA inspection to determine 4 DSB ID #: ECAD-5688 compliance with their permit and any applicable regulations. Additionally, EPA informed the Facility representatives of their right to claim any confidential business information (CBI). At that time, Tyrone Hate did not claim any photos or documentation as CBI. II. Site Activity/Process Description The Facility that Adare Pharma Solutions was founded under Mutual Pharmaceutical Company in 1984. In 2013, the Facility was acquired by Takeda Pharmaceuticals before being bought out by Frontida BioPharm Inc. in 2016. Adare Pharma Solutions acquired the Facility in 2021. The Facility is open 6 AM to 11 PM, Monday through Friday employing a first and second shift schedule with occasional Saturday shifts needed depending on production and contract obligations. Adare Pharma Solutions has 246 employees with 75 of those employees off site. The entire Facility is 193,000 square feet under roof with the Facility under this permit taking up 26,500 square feet. Adare Pharma Solutions is a small-scale Good Manufacturing Practices (GMP) Facility providing pharmaceutical tableting and capsule filling to various customers. Ingredients for manufacturing are obtained through venders who go through a qualification process to be certified to sell ingredients for pharmaceutical products. Sometimes, customers provide their own ingredients for the tablets and capsules which they have contracted Adare to produce instead of obtaining the ingredients from venders. All the ingredients and processes in tableting and capsule filling are regulated by the Food and Drug Administration (FDA). The process of tableting and capsule filling begins with granulation, where fine powder ingredients are made into granules often with the use of alcohol. A dust collector and catalytic oxidizer are used to control the emissions from this process. Once granulation is complete, the granules are sent to the ovens to dry. If alcohol was utilized in the granulation process, catalytic oxidizers are used as an emission control. From here, the granules are placed in drums and sent to milling and blending where the granules are milled down to the desired size and blended with other ingredients. Due to granules ability to still have PM and VOC emissions, the mill and blending processes have dust collector and catalytic oxidizer emission controls. Once milled and blended, the product is sent to tablet pressing which has a dust collector emission control. If desired by the customer, the tablets are sent to coating to be coated. Since the coatings sometimes contain alcohol, these production areas have dust collector and catalytic oxidizer emission controls. Adare Pharma has eight Dust Collectors in total for these processes and two catalytic oxidizers for emission controls. Every production area has a dust collector emission control. Processes requiring alcohol which includes the alcohol dispensing room, granulation, ovens, milling and blending as well as the coating rooms are split between Catalytic Oxidizer #1 and Catalytic Oxidizer #2 which use natural gas to produce heat the catalyst bed and produce a reaction using the oxidation reaction process maintain a temperature over 650-degree Fahrenheit to accomplish this. Adare Pharma Solutions operates two natural gas boilers used for process heat: a Weil-McLain LGB-23 with a capacity of 2.86 5 DSB ID #: ECAD-5688 MMBtu/hr and a Weil-McLain LGB-17W/SN with a capacity of 2.08 MMBtu/hr. Adare Parma Solutions has one emergency diesel generator, a Cummins Model DGFB-5704157. The opening conference concluded at 09:59 AM. III. Observations EPA inspectors were led on a walkthrough of the Facility at 11:29 AM by Tyrone Hart, Vivek Thapar and Shawn Watson of Adare Pharma Solutions and Duaa Sale (AMS) and Johana Borda-Perez (AMS) also present for the walkthrough. EPA inspectors noted photos would be taken during the Facility walkthrough (Attachment 2). The walkthrough began at the alcohol dispensing room where alcohol is dispensed for granulation if needed. We observed the catalytic oxidizer intake for the catalytic oxidizer emission control. Next to this were Rooms #1, #3 and Collette Room #15 H which were granulation rooms. Within these rooms we observed the granulation machinery which is a Glen Mixer used in the granulation process and the intakes for both emission controls, the dust collector and catalytic oxidizer. None of these rooms were being used at the time of inspection. Next observed were the ovens that dry the granules when water or alcohol is used for granulation. Ovens 9, 10, 11, and 12 are vented to Catalytic Oxidizer 1 and were not being used at the time of inspection. Ovens 18 and 19 are vented to Catalytic Oxidizer 2 and were not being used at the time of the inspection. After the ovens, the walkthrough proceeded to the Coating Room where the coating machine was observed with the intakes for the dust collect and catalytic oxidizer are kept. It was noted by Vivek Thapar that the Coating Room is kept under negative pressure during active production to assist with emissions control. After the Coating Room, the walkthrough proceeded to Collette #17 which was a room utilized both for granulation, blending and mixing depending on current operational need. It was here that Vivek Thapar that all the milling equipment is wheeled and can be transported to any production area. It is this reason that all production areas at least have an intake to a dust collector. Once fully blended, the product which is transferred in drums is sent to tableting, which was observed. The drums are loaded onto the tableting machine and a compressor is used to press the granulated mix into pill form. All the tableting press rooms have dust collectors to control emissions which were observed during the inspection. Once the full process of manufacturing was observed, the walkthrough proceeded to observe the emission controls. Catalytic Oxidizer #1 was shut down for routine maintenance. Catalytic Oxidizer #2 was on with a 700oF internal temperature and 674oF outlet temperature. EPA observed the pressure drop across several dust collectors: Dust Collector 6 had 0.5 inches of water, Dust Collector 4 had 0.8 inches of water, Dust Collector 2 had 0.6 inches of water, Dust Collector 3 had 1.1 inches of water and Dust Collector 1 had 0.6 inches of water. The walkthrough then proceeded to inspect both operating 6 DSB ID #: ECAD-5688 process natural gas boilers which are a Weil-McLain LGB-23 with a capacity of 2.86 MMBtu/hr and a Weil-McLain LGB-17W/SN with a capacity of 2.08 MMBtu/hr. After, the EPA inspectors inspected the emergency diesel generator, a Cummins Model DGFB-5704157 was recored to have 409.9 hours at the time of inspection and Tyrone Hart said that Foley Caterpillar was contracted to service the emergency generator. One area not inspected was the high potent processing room due to the need of fully encapsulated suits for personal protection equipment due to use of more potent pharmaceutical ingredients. The EPA inspectors asked Tyrone Hart if all the processes were the same as what was already explained and observed and Tyrone Hart confirmed this. The EPA inspectors were able to observe the granulation, mixing and blending equipment observed in the walkthrough through windows and confirm the intakes for both dust collector and oxidizer emission controls. The walkthrough concluded at 12:51 PM. IV. Records Review The records review commenced immediately after the opening conference before the facility walk through at 10:00 AM. EPA inspectors reviewed documents requested in the December 9, 2024 email to Tyrone Hart (see Attachment 1). Records were provided at the time of the inspection by Tyrone Hart. Below are the records requested and what was provided: 1. Provide a plot plan of the Facility. The plot plan should identify each production process unit to include but not limited to: pharmaceutical preparation and manufacturing Provided at the time of inspection 2. Provide a detailed process description of the Facility. This should include a description of each production process unit to include but not limited to: pharmaceutical preparation and manufacturing Provided at the time of inspection 3. For each of the pharmaceutical process production unit, provide the following information: a. Date of construction, date operation commenced at the Facility; b. Date the unit was modified or reconstructed; c. Provide the current and historical (as built) production capacity for each unit; Was not provided at the time of inspection, Tyrone Hart said the documents will be provided post inspection via secure link. 4. A list of all combustion sources at the Facility such as furnaces, boilers, and/or engines. a. For each boiler or engine identified, provide: i. Date of installation; ii. Type of fuel(s) combusted; iii. Maximum heat input rating (MMbtu, HP or kW/hr); 7 DSB ID #: ECAD-5688 iv. Days each unit operated and hours of operation1 monthly from January 2022 to the present. b. Fuel usage on a monthly basis for any combustion equipment at the Facility (boilers, emergency generators, fire pumps, etc.) since January 2022. c. Records of each tune-up conducted at each unit since January 2022. Was not provided at the time of inspection, Tyrone Hart said the documents will be provided post inspection via secure link. 5. Provide copies of the emission statements submitted to Philadelphia AMS for the years 20202024. These emission statements shall include the emission factors used to determine emissions and the derivation of each factor (stack test, CEMS, AP-42, etc.). Provided at the time of inspection. 6. Annual emissions calculations (preferably emailed in an unlocked Microsoft Excel format) since 2020, including but not limited to: a. Monthly rolling emissions of VOCs, HAPs and NOx for each process unit and facility wide along with supporting calculations for 2020-2024 (lbs/hr). Provided at the time of inspection. 7. Provide a list of any and each control device currently in use at Adare Pharma Solutions used to control or reduce emissions from any emission point at the site. The list should include: a. The make/model of the control; b. Date of installation at the Facility; c. Which pollutant(s) are being controlled; d. Each source or emission point being controlled; e. The capture and destruction efficiency for each control; Was not provided at the time of inspection, Tyrone Hart said the documents will be provided post inspection via secure link. 8. Copies of any stack tests conducted on any pharmaceutical process units to determine emission rate, control efficiency, or for compliance demonstrations, etc. conducted at the Facility since 2010. Provided at the time of inspection. 9. Provide a list of each request for permit determination or permit application submitted to the Philadelphia AMS since January 2020. Also, provide a list of each permit or permitting determination issued to Adare Phama Solutions. This should include the date of the request/permit and the permit number, if applicable. Provided at the time of inspection. 1 Hours of operation for each month should identify whether the hours were for testing, emergency, or non-emergency purposes. 8 DSB ID #: ECAD-5688 10. Provide copies of any initial notifications, compliance reports, and/or periodic reports submitted to either EPA or Philadelphia AMS pursuant to applicable regulations under 40 C.F.R. Part 60 and 63. Provided at the time of inspection. Records review concluded at 11:22 AM. V. Closing Conference After the records review, EPA inspectors, Tyrone Hart, Vivek Thapar, and Shawn Watson of Adare Pharma Solutions and Duaa Saleh and Johana Borda-Perez of AMS had a brief closing conference to ask additional questions and discuss observations. The EPA inspectors noted that the investigation is ongoing, and any areas of concern identified in the final report do not necessarily reflect a violation or deviation, rather, they are areas that will require further investigation. EPA also noted that they would issue an inspection report within 60 days, with a copy to the State. Simultaneously, EPA will perform a detailed review of records and may have additional questions. The inspection concluded at 01:02 PM. The following have been identified as potential issues during the inspection. They are issues that require either further investigation by EPA or additional information or explanation by Tyrone Hart. According to their Synthetic Minor Operating Permit No. OP18-000013 for Adare Pharma Solutions, Catalytic Oxidizer #1 and #2 shall perform a stack test every five years to demonstrate compliance with the 95% VOC destruction efficiency and it has been 7 years since the last stack test for Catalytic Oxidizer #1 and Catalytic Oxidizer #2's stack test needs to be completed in 2025. Adare Pharma Solutions did not have several of the requested records at the time of inspection. Adare Pharma Solutions has stated that they will get the records to the EPA Inspectors post inspection. At the time of this inspection report, those records had not been received by the EPA. 9 DSB ID #: ECAD-5688 VI. List of Attachments Attachment 1: Email correspondence to Tyrone Hart of records requested to review during inspection Attachment 2: Photo Log Attachment 3: Sign-in Sheet 10 From: To: Cc: Subject: Date: Attachments: Importance: Yanos, Scott (he/they) Tyrone Hart; Denise Richards Duaa Saleh; Adhikari, Parmatma Upcoming EPA Clean Air Act Inspection at Adare Pharma Monday, December 9, 2024 10:41:00 AM image003.png image004.png image005.png Adare Pharma Solutions Inspection Record Request.docx High Solutions Dear Mr. Tyrone Hart: I have tried to contact you via phone but have been unable to get a hold of you so I am following up with this email. I will continue to try and call in case you have any questions or concerns. I am contacting you because EPA Region 3 will be conducting a Clean Air Act (CAA) inspection of Adare Pharma Solutions on December 10, 2024. My colleague, Parmatma Adhikari, and I anticipate arriving at 1100 Orthodox Street, Philadelphia, PA 19124 around 9:00 AM. We would like to begin with an opening meeting that will provide EPA with the current and historical operations at the facility and a brief overview of its process(es). The scope of the inspection will include, but may not be limited to, a review of all air pollution sources, a facility walk-through (during which photographs will be taken), and a review of records. Philadelphia AMS been notified of the inspection and plans to attend. To help facilitate the inspection, it would be appreciated if the records in the attached document were made available for review. Please confirm receipt of this message and don't hesitate to contact me with any questions. Regards, Scott Yanos Life Scientist (Enforcement and Compliance Officer) Enforcement & Compliance Assurance Division US EPA Mid-Atlantic Region Phone 215-814-2128 Email yanos.scott@epa.gov ENFORCEMENT CONFIDENTIALITY NOTICE: This transmission is intended to be delivered only to the named addressee(s) and may contain information that is confidential, proprietary, attorney work-product or attorney-client privileged. If this information is received by anyone other than the named addressee(s), please notify the sender immediately, by reply e-mail and/or by telephone, to obtain instructions as to the disposal of the transmitted material. In no event shall this material be read, used, copied, reproduced, stored or retained by anyone other than the named addressee(s), except with the express written consent of the sender or the named addressee(s). Thank you. Attachment 2: PHOTO LOG Facility: Adare Pharma Solutions Location: Philadelphia, PA Inspection Date: December 10, 2024 EPA Inspector(s): Scott Yanos, Parmatma Adhikari Photographer: Parmatma Adhikari Photo Number: 001 Photo Description: Alcohol Room Adare Pharma Solutions 12/10/2024 Page 2 of 15 Photo Number: 002 Photo Description: Glen Mixer with Dust Collector Intake Adare Pharma Solutions 12/10/2024 Page 3 of 15 Photo Number: 003 Photo Description: Controls for the Drying Ovens Adare Pharma Solutions 12/10/2024 Page 4 of 15 Photo Number: 004 Photo Description: Drying Ovens 9, 10 and 11 Adare Pharma Solutions 12/10/2024 Page 5 of 15 Photo Number: 005 Photo Description: Coating Room with intake to RTO-2 Adare Pharma Solutions 12/10/2024 Page 6 of 15 Photo Number: 006 Photo Description: Milling Equipment Adare Pharma Solutions 12/10/2024 Page 7 of 15 Photo Number: 007 Photo Description: Blending Room Adare Pharma Solutions 12/10/2024 Page 8 of 15 Photo Number: 008 Photo Description: Tablet Pressing Room with Dust Collector Intake Adare Pharma Solutions 12/10/2024 Page 9 of 15 Photo Number: 009 Photo Description: Control Panel for Oxidizer #2 Adare Pharma Solutions 12/10/2024 Page 10 of 15 Photo Number: 010 Photo Description: Pressure Gauge for Dust Collector #6 Adare Pharma Solutions 12/10/2024 Page 11 of 15 Photo Number: 011 Photo Description: Boiler #1 Information Panel Adare Pharma Solutions 12/10/2024 Page 12 of 15 Photo Number: 012 Photo Description: Emergency Generator Information Panel Adare Pharma Solutions 12/10/2024 Page 13 of 15