Document nkqDEX1qq18avqkm0By04zoww

DATE: SUBJECT: FROM: THRU: TO: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGIONS 77 WEST JACKSON BOULEVARD CHICAGO, ILLINOIS 60604 MAY 2 0 2019 CLEAN AIR ACT INSPECTION REPORT Catalent Indiana LLC, Bloomington, Indiana Albana Bega, Enviromnental Engineer AECAB (MI/WI) Sarah Marshall, Section Chief AECAB (MI/WI) File BASIC INFORMATION Facility Name: Catalent lndiana LLC Facility Location: 1300 South Patterson Drive, Bloomington, Indiana Date of Inspection: March 27, 2019 EPA Inspector(s): I. Albana Bega, Environmental Engineer 2. Luke Hullinger, Enviromnental Engineer Other Attendees 1. Andrew Smith, Director Environmental Health and Safety 2. Sarah Carman, Senior Quality Assurance Representative 3. Margo Sacha, Senior Manager, Quality Assurance Catalent Biologics Contact Email Address: Andrew.Smith@catalent.com Purpose of Inspection: Synthetic minor limit, NSPS Boilers Facility Type: Biopharmaceutical Manufacturing Regulations Central to Inspection: NSPS Subpart Db - six boilers Arrival Time: 10:00 Departure Time: 13:45 Inspection Type: l2l Unannounced Inspection A.iu10unceJ Inspection OPENING CONFERENCE l2l Credentials Presented l2l CBI warning to facility provided The following information was obtained verbally from Mr. Smith unless otherwise noted. Company Ownership: Catalent Inc. acquired Cook Pharmica LLC in October 2017. Process Description: The Cook Pham1ica Group started the Cook Phannica LLC facility in Bloomington Indiana (facility) in 2004 as a contract development and manufacturing facility with biopharmaceutical and fill-finish capabilities. Specifically, the facility provides research and development services, commercial and clinical scale drug substance manufacturing, supply services such as cell bank generation and storage, and stability testing and storage. The facility has one enclosed Mammalian Cell Culture process line, which produces mairunalian cell culture-based biopharmaceuticals, including monoclonal antibodies and proteins manufactured using genetically engineered organisms controlled with lab hood. In addition, the facility has two Fill Finish process lines (vial and syringe filling lines), consist of manufacturing of sterile, injectable pharmaceuticals for the medical industry, controlled with lab hood. Fill Filling process lines products manufactured include solutions, suspensions, emulsions and freeze-dried powders encompassing human and veterinary small molecule, vaccine and protein pharmaceuticals. Staff Interview: The facility operates 24 hours a day, seven days a week and has approximately 1,050 employees. It is a large quantity generator of hazardous waste but a synthetic minor under the CAA prograin. The manufacturing process is a batch process that uses stainless steel reactors of 600 to 2,500 liters capacity. Each batch takes approximately 4-6 weeks. Clean-in-place (CIP) is the process equipment (reactor) method of cleaning and the two cleaning solutions used contains no hazardous air pollutants/volatile organic compounds. Wastewater from cleaning process collects through facility's drains to the facility's wastewater treatment systems (a total of two). Waste materials not treated onsite are collected in bags and containers and shipped offsite on tanker truck as hazardous waste. The facility has six natural gas-fired boilers and four dieselfired generators. Boilers are on a preventive maintenance schedule. Page 2 of3 TOUR INFORMATJON EPA toured the facility: Yes Data Collected aud Observations: The facility was in full operation on the day of this inspection. The following were observed during the tour: Inspection area Development lab Building A (two boilers and wastewater treatment systems) Building B (four boilers) Cooling towers Emergency diesel-fired generators Photos and/or Videos: were taken during the inspection. Field Measurements: were not taken during this inspection. RECORDS REVIEW 1. Introduction to Cook Pharma PowerPoint presentation (contains infom1ation claimed as confidential business infom1ation, taken) 2. December 2018 industrial wastewater report and the January 2019 monthly industrial reporting form (taken) 3. Boiler #1 and #2 annual testing reports (taken) 4. Boilers' preventive maintenance schedule (taken) 5. CJP 100 and 200 (cleaning solutions) safety data sheets (taken) CLOSING CONFERENCE Requested documents: None =~:~--: SIGNATURES Report Author: Section Chief:---~ ~ Date: Cl)/ [1 fJ,.D/ ~ Date: 5 /Jo /1? 7 7 Page 3 of3 Facility Name~ Catalent Indiana LLC Facility Location: 1300 South Patterson Drive, Bloomington, Indiana Date of Inspection: March 27, 2019 APPENDIX A: DIGITAL IMAGE LOG 1. Inspector Name: AlbanaBega 3. Company/Facility Name: -- CaLaknL lHu1a..ila .LLL 5. Number of Images: 8 2, Date(s) oflnspection: March 27, 2019 4. Street Address, City, State: -, r,r, ,-, 1 ,, ,,, To"'i i.)VV UUULH ruLu.::1::;un UllVt:, DH.JU.UHll~LUH, JilUfolfrt 6. Archival Record Location: C:\Users\ABega\OneDrive - Environmental Protection Agency (EPA)\CookPharmicaLLC- Bloomimrton-IN Image Number 1 2 3 4 5 6 7 8 File Name IMG 3647.JPG IMG 3648.JPG IMG 3649.JPG IMG 3650.J PG IMG 3651.JPG IMG 3652.JPG IMG 3653.JPG IMG 3654.JPG Date and Time (incl. time zone and DST) 3/27/2019 13:46 3/27/2019 12:15 3/27/2019 13:46 3/27/2019 12:30 3/27/2019 12:31 3/27/2019 12:31 3/27/2019 12:33 3/27/2019 12:33 Description of Image Boiler Plate for Boiler #2 (Bldg A) Boiler Plate for Boiler #1 (Bldg A) Boiler Plate for Boiler #12 (Bldg B) Boiler Plate for Boiler #11 (Bldg B) Boiler Plate for Boiler #4 (Bldg B) Boiler Plate for Boiler #3 (Bldg B) Certificate of Inspection for Boiler #4 (Bldg B) Certificate of Inspection for Boiler #3 (Bldg B) Appendices Page 1 of l