Aseptic Processing

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Sections: Aseptic Processing | Clean Rooms | Media Fills

Aseptic Processing

  • Agallaco, JP et al. 2004. A Critical Review of FDA’S 2003 Draft Guidance and a Proposed Alternative. Pharm Technol. Aseptic Proc:16-22.
  • Chiarello, K. 2004. Pharma Industry Drives Innovation In Barrier/Isolation Design. Pharm Technol. Mar:44-53.
  • Cundell, AM. 2004. Microbial Testing In Support of Aseptic Processing. Pharm Technol. June:58-66.
  • Johnson, R and D Miner. 2004. The Path to Good Aseptic Guidance. PDA J Pharm Sci Tech. 58:59-61.
  • Langille, S and D Hussong. 2004. Status and Direction of Aseptic Processing in the United States – 2004. Amer Pharm Rev. 7:28-54.
  • Leo, F et al. 2004. Evaluation of Blow/Fill/Seal Extrusion Through Processing Polymer Contaminated with Bacterial Spores and Endotoxin. PDA J Pharm Sci Tech. 58:147-158.
  • Ljungqvist, B and B ReinmĂĽller. 2004. The LR Method In Critical Areas – Airflow Patterns and the Design of Aseptic Interventions. Pharm Technol. July:46-54.
  • Madsen, RE. 2004. The Future of Aseptic Processing—An Update. Pharm Technol. Aseptic Proc:8.
  • PDA. 2004. Aseptic Processing Case Studies. PDA Letter. July:16-17.
  • PIC/S. 2004. PI 006-2 Recommendations On Validation Master Plan Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation. Guidance. 38169 .
  • PIC/S. 2004. PI 007-2 Recommendation On the Validation of Aseptic Processes. Guidance. 38169 .
  • Robinson, G. 2004. Standing Operating Procedures: Logbooks/Sheets for Contamination Control Cleaning. A2C2. 7:9-13.
  • Roganti, F and RJ Boeh. 2004. Design of an Aseptic Process Simulation. Pharm Technol. Sept:76-84.
  • Stockdale, D. 2004. Isolator Campaigning – An Industry Survery and Discussion of Operational Practices. Pharm Eng. 24:96-102.
  • Suzuki, O et al. 2004. Design Criteria and Evaluation of Pharmaceutical Containment Systems – Evaluation of Closed Isolation Systems. Pharm Eng. 24:44-56.
  • Anon. 2003. FDA Concept Paper Fuels Debate Over Aseptic Processing Standards. The Gold Sheet. 37 .
  • Cooper, Murray. 2003. Aseptic Processing. Microbiological Update. 21 .
  • Davis, SJ. 2003. Cleanroom Pressurization Methodology: Prime Consideration for Pharmaceutical Facilities. Pharm Technol. Feb:54-58.
  • DeSantis, F et al. 2003. Aseptic Formulation and Filling Using Isolator Technology. Pharm Technol. Outsourcing:32-42.
  • FDA. 2003. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice. Draft Guidance. Aug .
  • Forcinio, H. 2003. Concept Paper Discusses Update of Aseptic Processing Guidelines. Pharm Technol. Mar:38-44.
  • PDA. 2003. Points to Consider for Aseptic Processing. PDA J Pharm Sci Tech. Suppl 57 .
  • Rios, M. 2003. Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators. Pharm Technol. Nov:36-48.
  • Akers, JE. 2002. Science Based Aseptic Processing. PDA J Pharm Sci Tech. 56:283-290.
  • Akers, JE and JP Agalloco. 2002. Aseptic Processing, Elephants, Blind Men and Sterility. PDA J Pharm Sci Tech. 56:231-234.
  • Cooper, Murray. 2002. Aseptic Processing. Microbiological Update. 19 .
  • Cooper, Murray. 2002. Aseptic Processing. Microbiological Update. 20 .
  • FDA. 2002. Preliminary Concept Paper – Sterile Drug Products Produced by Aseptic Processing Draft. Draft Guidance. Sept .
  • FDA Presentation. 2002. Sterile Drug Products Produced by Aseptic Processing Draft. FDA Presentation. . .
  • PDA. 2002. FDA Releases Long Awaited Draft Concept Paper On Aseptic Processing. PDA Letter. 38:1-15.
  • PDA. 2002. PDA Tech Report #36: Current Practices In the Validation of Aseptic Processing – 2001. PDA J Pharm Sci Tech. 56 .
  • PDA. 2002. Points to Consider for Aseptic Processing. PDA J Pharm Sci Tech. June:35 pgs.
  • PDA Aseptic Task Force. 2002. Final Draft: Points to Consider for Aseptic Processing. PDA Draft Document. Sept .
  • PIC/S. 2002. PI 014-1 Recommendation On Isolators Used for Aseptic Processing and Sterility Testing. PIC/S. . .
  • Agalloco, J. 2001. Be Careful What You Wish for (Letter to the Editor). PDA J Pharm Sci Tech. 55:263-264.
  • Agalloco, James P. et al. 2001. Tech Report #34: Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products. PDA J Pharm Sci Tech.
  • Akers, JE. 2001. Aseptic Process Simulation – a Review of PDA Technical Reports 22 & 28. Proceedings: Bridging the Healthcare and Pharmaceuticals Worlds In the New Millennium, Kyoto Japan. 55:127-130.
  • Cooper, Murray. 2001. Aseptic Processing. Microbiological Update. 19 .
  • Deguchi, M et al. 2001. Development of an Advanced High Speed Aseptic Filling System. Proceedings: Bridging the Healthcare and Pharmaceuticals Worlds In the New Millennium, Kyoto Japan. 55:57-63.
  • PDA. 2001. PDA Letter to the FDA Regarding Process Simulation Testing. PDA J Pharm Sci Tech. 55:145-149.
  • PIC/S. 2001. Recommendation On the Validation of Aseptic Processing. PIC/S.
  • Scott, IM, and M Durrant. 2001. Aseptic FDA-Compliant Valve Design. Pharm Tech Eur. 13:36-44.
  • Wechsler, J. 2001. Bioterrorism Threat Shines Spotlight On Drug Manufacturing. Pharm Technol. Dec:14-22.
  • Akers, JE and J Agalloco. 2000. Isolators – Validation and Sound Scientific Judgement. PDA J Pharm Sci Tech. 54:110-111.
  • Cooper, Murray. 2000. Aseptic Processing. Microbiological Update. 18 .
  • Farquaharson, G. and W. Whyte. 2000. Isolators and Barrier Devices In Pharmaceutical Manufacturing. PDA J Pharm Sci Tech. 54:33-43.
  • Krishna, Aravind. 2000. Isolation Technology for Research and Development Applications: From Concept to Production. Pharm Dev & Tech. 5:507-520.
  • Murtough, S.M. 2000. A Survey of Disinfectant Use In Hospital Pharmacy Aseptic Preparation Areas. Pharm J. .:3 pgs.
  • Ogawa, M. 2000. Contamination Control In Hvac Systems for Aseptic Processing Area; Part I: Case Study of the Airflow Velocity In a Unidirectional Airflow Workstation with Computational Fluid Dynamics. PDA J Pharm Sci Tech. 54:27-31.
  • Agalloco, J. 1999. Barriers, Isolators and Microbial Control. PDA J Pharm Sci Tech. 53:48-53.
  • Akers, JE. 1999. Editorial: Who Is the Beneficiary?. PDA J Pharm Sci Tech. 53:155-156.
  • Akers, Michael. 1999. Aseptic Processing and the Pharmaceutical Scientist. Amer Pharm Review. June:31-34.
  • Cooper, Murray. 1999. Aseptic Processing. Microbiological Update. 17 .
  • PDA. 1999. PDA Comments On Proposed Revisions to USP Chapter <1116>. PDA Letter. Sept:21-24.
  • PDA. 1999. PDA Comments: PIC Draft Recommendations On the Inspection of Isolator Technology. PDA J Pharm Sci Tech. 53:141-147.
  • Swain, Erik. 1999. Guide Will Clarify Use of Barrier Isolation. Pharm & Med Packaging News. Apr:51-55.
  • Wilson, James. 1999. Aseptic Process Monitoring-A Better Strategy. PDA J Pharm Sci Tech. 53:111-114.
  • Agalloco, J. 1998. Production and Validation of Sterile Bpc Operations: an Overview of the PDA/Phrma Process Simulation for Sterile Bulk Pharmaceutical Chemicals Draft Guidance Document. Proceedings: PDA Int Congress, Basel ’98. 52:259-280.
  • Cooper, Murray. 1998. Aseptic Processing. Microbiological Update. 16 .
  • ISO. 1998. ISO 13408-1 Sterilization of Health Care Products – Aseptic Processing – Part 1: General Requirements. ISO/DIS 13408-1. .:34-49.
  • Olson, WP. 1998. Opinion: Aseptic Processing and Parametric Release. PDA J Pharm Sci Tech. 52:13.
  • PDA. 1998. PDA Tech Report #28: Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals. PDA J Pharm Sci Tech. 52 .
  • Cooper, Murray. 1997. Aseptic Processing. Microbiological Update. 14 .
  • Cooper, Murray. 1997. Aseptic Processing. Microbiological Update. 15 .
  • Korczynski, MS. 1997. An International Perspective of Aseptic Processing. Proceedings of the Int Symposium “Global Pharmaceutical Manufacturing In the 21St Century, Osaka Japan (PDA). 51 .
  • PDA. 1997. PDA Tech Report #24: Current Practices In the Validation of Aseptic Processing – 1996. PDA J Pharm Sci Tech. 51 .
  • PIC/S. 1997. Recommendations On Validation of Aseptic Processes. PIC/S. Nov:1-15.
  • Cooper, DW. 1996. Cleaning Aseptic Fill Areas. Pharm Technol. 20:52-60.
  • Cooper, Murray. 1996. Aseptic Processing. Microbiological Update. 14 .
  • JP. 1996. 1. Media Fill Test. JP XIII. .:1065-1068.
  • JP. 1996. 60. Sterilization and Aseptic Manipulation, and Reverse Osmosis-Filtration. JP XIII. .:181-182.
  • Korczynski, MS. 1996. The ISO Draft International Standard – Aseptic Processing of Health Care Products. PDA J Pharm Sci Tech. 50:189-195.
  • PDA. 1996. Draft-Process Simulation Testing for Aseptically Filled Products. PDA. .:30-48.
  • PDA. 1996. PDA Tech Report #22: Process Simulation Testing for Aseptically Filled Products. PDA J Pharm Sci Tech. 50:S1-S16.
  • PDA. 1996. PDA’s Commentary On FDA’s “Drug Product Guidance”. PDA J Pharm Sci Tech. 50:277-279.
  • Agalloco, J. 1995. Opportunities and Obstacles In the Implementation of Barrier Technology. PDA J Pharm Sci Tech. 49:244-248.
  • Cooper, Murray. 1995. Aseptic Processing. Microbiological Update. 13 .
  • Cooper, Murray. 1994. Aseptic Processing. Microbiological Update. 12 .
  • Hargreaves, P. 1994. Recent Trends and Problems In Aseptic Processing. PDA Asian Symposium 11/14/94. 48:13-20.
  • Korczynski, MS. 1994. ISO Document: Aseptic Processing of Health Care Products – a Global Alternative. Proceedings of the Int Congress “Advanced Pharmaceutical and Biopharmaceutical Development, Manufacturing and Control In Europe and the USa”, Basel, Switzerland (PDA). 48 .
  • Lee, Gerard; Midcalf, Brian. 1994. Isolators for Pharmaceutical Applications. H M S O. .:1-50.
  • Levchuk, JW. 1994. Good Validation Practices: FDA Issues. PDA J Pharm Sci Tech. 48:221-223.
  • Akers, JE. 1993. Comparative Clean Room GMPs. Proceedings: Second Int PDA Congress; Validation of Pharmaceuticals and Biopharmaceuticals, Basel Switzerland. 47:110-117.
  • Akers, JE. 1993. Simplifying and Improving Process Validation. PDA J Parenteral Sci Tech. 47:281-284.
  • Barr, D. 1993. FDA’s Aseptic Processing: Proposed Regulation. PDA J Parenteral Sci Tech. 47:57-59.
  • Cooper, Murray. 1993. Aseptic Processing. Microbiological Update. 11 .
  • Cooper, Murray. 1993. Aseptic Processing and Environmental Control. Microbiological Update. 11 .
  • Haas, PJ et al. 1993. Validation Concerns for Parenteral Filling Lines Incorporating Barrier Isolation Techniques and CIP/SIP Systems. Proceedings: Validation of Pharmaceuticals and Biopharmaceuticals, Basel Switzerland. 47 .
  • Agalloco, J. 1992. A Review of the US FDA Guideline On Aseptic Processing. PDA J Parenteral Sci Tech. 46:78-84.
  • Akers, JE. 1992. PDA Response: FDA Proposal to Amend cGMP’s Entitles “Use of Aseptic Processign and Terminal Sterilization In the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use. PDA J Parenteral Sci Tech. 46:65-68.
  • Baseman, Harold. 1992. Sip/Cip Validation. Pharm Eng. 12:37-46.
  • Carroll, M et al. 1992. Microbiological Validation of a New Manufacturing Complex for an Injectable Biological Product. PDA J Parenteral Sci Tech. 46:107-110.
  • Cooper, Murray. 1992. Aseptic Processing and Environmental Control. Microbiological Update. 10 .
  • Cooper, Murray. 1992. The Compendial, Industry, and Regulatory Initiatives Regarding Aseptically Processed Sterile Products. PDA J Parenteral Sci Tech. 46:48-50.
  • Frieben, WR and RM Enzinger. 1992. Sterile Product Manufacturing Technology. PDA J Parenteral Sci Tech. 46:85-86.
  • Jane, J et al. 1992. Desing and Validation of an Aseptic Filling Process of Lvps Using Flexible Isolator System. PDA Int Congress 2/17/92. 46:52-63.
  • Korczynski, MS. 1992. Editorial: the ISO Aseptic Processing Document Under Development. PDA J Parenteral Sci Tech. 46:101.
  • Korczynski, MS. 1992. Response to the New USP Proposal – Microbial Evaluation and Classification of Clean Rooms. Proceedings: PDA/Ies Joint Conference On Cleanrooms and Microenvironments. 46:92-96.
  • PDA. 1992. PDA Tech Report #17: Current Practices In the Validation of Aseptic Processing – 1992. PDA J Parenteral Sci Tech. 46 .
  • PMA Sterilization Steering Committee. 1992. Terminal Sterilization and Aseptic Processing. Pharm Technol. Apr:52-58.
  • White, Thomas X. 1992. Terminal Sterilization and Aseptic Processing. Pharm Technol. 46:16-20.
  • Beer, CL. 1991. Gowning Training: the Use of Video Recording with Microbial Assessment. PDA J Parenteral Sci Tech. 45:128-131.
  • Bradley, A. 1991. Airborne Microbial Challenges of Blow/Fill/Seal Equipment: A Case Study. PDA J Parenteral Sci Tech. 45:187-192.
  • Dixon, AM. 1991. Training Cleanroom Personnel. PDA J Parenteral Sci Tech. 45:276-278.
  • FDA. 1991. Use of Aseptic Processing and Terminal Sterilization In the Preparation of Sterile Pharmaceuticals. Federal Register. 56:354-358.
  • Lorenz, MR and JS Robinson, Jr. 1991. Boundary and Airlock Design Issues In Aseptic Facilities. PDA J Parenteral Sci Tech. 45:279-285.
  • Sharp, J. 1991. Apples, Oranges and Additive Assurance. PDA J Parenteral Sci Tech. 45:122-123.
  • Thiboutot, R. et al PDA. 1991. Aseptic Processing and Terminal Sterilization. PDA J Parenteral Sci Tech. 45:254-258.
  • Agalloco, James, and James Akers. 1990. Comments On the Calculation of Sterility Assurance Levels. PDA J Parenteral Sci Tech. 44:293.
  • Avallone, HL. 1990. Manufacture of Clinical Products. Pharm Technol. Sept:150-158.
  • Enzinger, R.M. 1990. Sterility Assurance From Post-Filling Heat Treatment. PDA J Parenteral Sci Tech. 44:294-295.
  • Enzinger, RM. 1990. Process Development Issues for Sterile Products: Introduction: Industry Issues. Proceedings of the PDA/PMA Sterilization Conference. 44:233-237.
  • Hitchcock, John. 1990. Can Operators Be Removed From the Clean Room. Manufact Chem. 61:26-27.
  • PDA. 1990. PDA Tech Report #20: Report On Survey of Current Industry Gowning Practices. PDA J Parenteral Sci Tech. 44.
  • Sharp, J. 1990. Aseptic Validation of a Form/Fill/Seal Installation: Principals and Practice. PDA J Parenteral Sci Tech. 44:289-292.
  • Avallone, HL. 1989. Aseptic Processing of Non-Preserved Parenterals. PDA J Parenteral Sci Tech. 43:113.
  • Cooper, Murray. 1989. Aseptic Processing and Environmental Control. Microbiological Update. 7.
  • Lee,J.Y. 1989. Auditing an Aseptic Filtration Process. Pharm Technol. Feb:66-72.
  • Sharp, J. 1989. Manufacture and Control of Sterile Products. Manufact Chem. 60:49-53.
  • Sharp, J. 1989. Manufacture and Control of Sterile Products Part 2. Manufact Chem. 60:57-61.
  • Akers, JE et al. 1988. A Review of Current Technology In Parenteral Manufacturing (As Per Erratum 42(2):141). PDA J Parenteral Sci Tech. 42:53-56.
  • Akers, JE et al. 1988. PDA’s Response to FDA’s “Guideline On Sterile Drug Products Produced by Aseptic Processing”. PDA J Parenteral Sci Tech. 42:114-117.
  • Conrad, D et al. 1988. Letter to the Editor: . PDA J Parenteral Sci Tech. 42:176.
  • Kerns, WT. 1988. Aseptic Clean Room Process Validation. a Total Environment Approach. Int Profiles of Regulatory Compliance. 4.
  • McClure, H. . 1988. Sterilization In Place: How to Sterilize Liquid Filling Equipment At Point of Contact. Pharm Eng. 8:14-17.
  • Cooper, Murray. 1987. Aseptic Processing. Microbiological Update. 4.
  • Cooper, Murray. 1987. FDA Aseptic Processing Guidelines. Microbiological Update. 5.
  • Cooper, Murray. 1987. Version of the FDA Guideline On Sterile Drug Products Produced by Aseptic Processing. Microbiological Update. 5.
  • FDA. 1987. Guideline On Sterile Drug Products Produced by Aseptic Processing. . June .
  • Fry, EM. 1987. FDA Update On Aseptic Processing Guidelines. PDA J Parenteral Sci Tech. 41:56-60.
  • Gilbert, Peter. 1987. New Approach to Sterile Products Teaching At Manchester University. Pharm J. Jan:62-64.
  • USP. 1987. <1211> Sterilization and Sterility Assurance of Compendial Articles. Pharm Forum. 13:2917-2918.
  • Cooper, Murray. 1986. Aseptic Processing. Microbiological Update. 4.
  • Cooper, Murray. 1986. Aseptic Processing and Environmental Control. Microbiological Update. 4 .
  • Seiberling, DA. 1986. Clean-In-Place & Sterilize-In-Place Applications In the Parenteral Solutions Process. Pharm Eng. 6:30-35.
  • Wasynczuk, J. 1986. Validation of Aseptic Filling Processes. Pharm Technol. May:36-43.
  • Avallone, HL. 1985. Control Aspects of Aseptically Produced Products. PDA J Parenteral Sci Tech. 39:75-79.
  • FDA. 1985. Guideline On Sterile Drug Products Produced by Aseptic Processing. The Gold Sheet. 19:S-1-S-14.
  • Fry, EM. 1985. An FDA Update On GMP’s for Aseptic Processing. PDA J Parenteral Sci Tech. 39:154-157.
  • Blackmer, RA. 1984. Sterile Operations Facility. PDA J Parenteral Sci Tech. 38:183-189.
  • Mostise, Paul. 1983. cGMP Requirements for Sterile Drug Products. Pharm Eng. Jul-Aug:23&26.
  • Sharp, John. 1982. Sterile Area Design. Manufact Chem. 53:47-49.
  • Ferrer, E.B. 1981. Effective Airflow Velocities for Clean Station Devices. Pharm Technol. 15:76-89.
  • PDA. 1980. PDA Technical Monograph #2: Validation of Aseptic Filling for Solution Drug Products. PDA. 34:1-30.
  • PMA. 1980. Editorial: Pma Comments On the Canadian Msi Proposal. PDA J Parenteral Drug Assoc. 34:245-247.
  • Lipscomb, B and KE Avis. 1979. Aerobiological Model for Assessing Microbial Contamination. PDA J Parenteral Drug Assoc. 33:3-16.
  • Anisfeld, MH and CK Lovejoy. 1978. Design for a Small-Volume Parenteral Manufacturing Facility. PDA J Parenteral Drug Assoc. 32:285-290.
  • Baird, Rosamund; Ann Parks. 1977. Control of Pseudomonas aeruginosa In Pharmacy Environments and Medicaments. Sci & Technology. Aug:164-165.
  • Griffin, JC and WA Pauli. 1976. Design Concepts for a Sterile Products Production Facility. PDA Bulletin of Parenteral Drug Assoc. 30:293-298.
  • Korczynski, MS, et al. 1975. Sterilization of Parenteral Solutions – an Integrated Program. PDA Bulletin of Parenteral Drug Assoc. 29:146-152.
  • Longworth, A. 1975. The Manufacture of Sterile Topical Products. PDA Bulletin of Parenteral Drug Assoc. 29:238-249.
  • Smith, GG et al. 1975. New Process for the Manufacture of Sterile Ophthalmic Ointments. PDA Bulletin of Parenteral Drug Assoc. 29:18-25.
  • Woods, AD. 1975. Design and Construction of an Australian Sterile Products Plant. PDA Bulletin of Parenteral Drug Assoc. 29:26-38.
  • Rohde, PA et al. 1974. Challenging the Sterility of a Sterile Powder Filling Line. PDA Bulletin of Parenteral Drug Assoc. 28:241-246.
  • Dawson, F.W. 1973. Some Techniques for Microbial Control In Manufacturing Plants. J Soc Cosmet Chem. 24:655-662.
  • Hortig, H. 1973. Laminar Flow In the Pharmaceutical Industry. PDA Bulletin of Parenteral Drug Assoc. 27:38-47.
  • Kiritsy, PA, and R Engvall. 1973. Sterile Filling Facility – Its Design, Construction and Operation. PDA Bulletin of Parenteral Drug Assoc. 27:279-286.
  • Howarth, WR. 1972. Environmental Control In Parenteral Filling Operations. PDA Bulletin of Parenteral Drug Assoc. 26:147-152.
  • Miller, W.S. 1972. Microbiological Controls In Packaging. Drug Cosmet Ind. 110:38-43, 113-116.
  • Kotaski, JA. 1971. Elimination of Contamination From Personnel In Sterile Manufacturing Areas. PDA Bulletin of Parenteral Drug Assoc. 25:203-207.
  • Fornabaio, TA. 1970. Design and Operation of a New Sterile Manufacturing Facility. PDA Bulletin of Parenteral Drug Assoc. 24:110-118.
  • Loughhead, H and a Vellutato. 1969. Parenteral Production Under Laminar Air Flow. PDA Bulletin of Parenteral Drug Assoc. 23:17-22.
  • Baker, AK. 1960. Filtration of Air Supply to Sterile Filling Rooms. PDA Bulletin of Parenteral Drug Assoc. 14:8-16.
  • Brown, JH. 1954. Ideal Conditions for Aseptic Filling. PDA Bulletin of Parenteral Drug Assoc. 8:6-11.
  • Steffen, GI. 1954. The Value of Periodic Health Examinations of Manufacturing Personnel. PDA Bulletin of Parenteral Drug Assoc. 8:24-28.
  • Theodore, Frederick et al. 1952. Practical Suggestions for the Preparation and Maintenance of Sterile Ophthalmic Solutions. Amer J Ophthalmol. 35:656-658.

Clean Rooms

  • Farquharson, G. 2002. Clean Rooms and Associated Controlled Environments. Pharm Tech Eur. 14:43-47.
  • JP. 1999. Microbio Eval of Processing Areas for Sterile Pharmaceutical Products. JP Pharm Forum. 8:157-162.
  • USP. 1999. <1116>Microbiological Evaluation of Clean Rooms and Other Controlled Environments. Pharm Forum. 25:8264-8279.
  • Hyde, WA. 1998. Origin of Bacteria In the Clean Room and Their Growth Requirements. PDA J Pharm Sci Tech. 52:154-158.
  • JP. 1998. Microbio Eval of Processing Areas for Sterile Pharmaceutical Products. JP Pharm Forum. 7:139-144.
  • JP. 1997. Microbio Eval Test for Processing Areas of Sterile Pharmaceutical Products-Addition. JP Pharm Forum. 6:16-20.
  • JP. 1997. Microbio Eval Test for Processing Areas of Sterile Pharmaceutical Products. JP Pharm Forum. 6:6-12.
  • PDA. 1997. PDA Comments: USP On Microbiological Evaluation of Clean Rooms and Other Controlled Environments <1116>. PDA J Pharm Sci Tech. 51:222-226.
  • USP. 1997. <1116>Microbiological Eval of Clean Rooms and Other Controlled Environments. Pharm Forum. 23:5269-5295.
  • USP. 1997. <1116>Microbio Eval of Clean Rooms and Other Controlled Environments. JP Pharm Forum. 23:3494-3520.
  • Cooper, DW. 1996. Sterility Assurance for Cleanroom Wipers. J Inst Environ Sci. 39:31-36.
  • PDA. 1995. PDA Comments On USP In-Process Revision <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments. PDA J Pharm Sci Tech. 49:264-266.
  • Dominguez, M. 1992. Applying Eec and Pic GMPs for Clean Room Design. PDA Int Congress 2/17/92. 46:81-89.
  • Houten, J. 1992. Containment: Comprehensive Assessment and Integrated Control. PDA J Parenteral Sci Tech. 46:22-24.
  • USP. 1992. <1116>Microbial Evaluation and Classification of Clean Rooms and Clean Zones – In Process Revision. Pharm Forum. 16:4042-4054.
  • USP. 1992. <1116>Microbiological Evaluation and Classification of Clean Rooms and Clean Zones. Pharm Forum. 18:4042-4054.
  • Howorth, F.H. 1987. Prevention of Airborne Infection In Operating Rooms. Nat News Brit J Theatre Nursing. 24:13-15.
  • Redlin, W.J.et al. 1987. Garments for Clean Room Operators: Demands of the 90′s. J Soc Environ. 26:17-19.
  • Whyte, W. et al. 1979. Monitoring the Causes of Cleanroom Contamination. Man Chemnews. 50:65-81.
  • Noble, W.C. 1978. Dispersal of Bacteria From Human Skin. J Environ Sci. 21:25-28.
  • Spooner, DF. 1973. Microbiology Training and Pharmaceutical Production. PDA Bulletin of Parenteral Drug Assoc. 27:257-265.
  • Heuring, H.et al. 1970. People: Key to Contamination Control. Contamn Control. 9:18-20.
  • Loughhead, H. 1969. Training of Clean Room Personnel. PDA Bulletin of Parenteral Drug Assoc. 23:228-232.
  • Hall, NC. 1968. Microbiological Control for Sterile Pharmaceutical Products. PDA Bulletin of Parenteral Drug Assoc. 22:187-192.
  • Favero, M.S. et al. 1966. Comparative Levels and Types of Microbial Contamination Detected In Industrial Clean Rooms. Appl Microbiol. 14:539-551.
  • Gassner, WF. 1965. Sanitization and Maintenance of Sterile Areas. PDA Bulletin of Parenteral Drug Assoc. 19:80-82.

Media Fills

  • Kawamura, K and H Abe. 2004. A Novel Approach to the Statistical Evaluation of Media Fills Tests by the Difference from No Contamination Data. PDA J Pharm Sci Tech. 58:309-320.
  • Kawamura, K. 2002. Letter to the Editor: Media Fills. PDA J Pharm Sci Tech. 56:57-58.
  • Kunio, K and H Abe. 2002. Consideration of Media Fill Tests for Evaluation and Control of Aseptic Processes: a Statistical Approach to Quality Criteria. PDA J Pharm Sci Tech. 56:235-241.
  • Halls, Nigel A. 2000. Practicalities of Setting Acceptance Criteria for Media Fill Trials. PDA J Pharm Sci Tech. 54:247-252.
  • Levchuk, John. 1998. CBER Reviewer John Levchuk On Media Fill Trouble Spots. Quality Control Reports – Gold Sheet. Sept:8-11.
  • Van Doorne, H., et al. 1998. Industrial Manufacture of Parenteral Products In the Netherlands. a Survey of Eight Years of Media Fills and Sterility Testing. PDA J Pharm Sci Tech. 52:159-164.
  • Bernuzzi, M et al. 1997. Applications of Statistical Models to Action Limits for Media Fill Trials. Eur J Parenteral Sci. 2:3-11.
  • Akers, JE. 1995. Commentary On Standards for Media Fill Testing. PDA J Pharm Sci Tech. 49:204-206.
  • Prout, Jerry and Deeks, Trevor. 1995. Dr. Kunio Kawamura On the Subject of Media Fills. PDA J Pharm Sci Tech. 49:57-58.
  • Deeks. 1994. ISO TC 198/WG9 – Aseptic Processing of Healthcare Products – Media Fills – a European Perspective. PDA Int Congress, 2/14-16/1994. 48:41-50.
  • Kawamura, K. 1994. Letter to the Editor, Media Fills. PDA J Pharm Sci Tech. 48:220.
  • Agalloco, JP and BM Gordon. 1987. Current Practices In the Use of Media Fills for the Validation of Aseptic Processing. PDA J Parenteral Sci Tech. 41:128-141.