title: Validation of Contamination Control in Rapid Transfer Port Chambers for Pharmaceutical Manufacturing Processes.
abstract: There is worldwide concern with regard to the adverse effects of drug usage. However, contaminants can gain entry into a drug manufacturing process stream from several sources such as personnel, poor facility design, incoming ventilation air, machinery and other equipment for production, etc. In this validation study, we aimed to determine the impact and evaluate the contamination control in the preparation areas of the rapid transfer port (RTP) chamber during the pharmaceutical manufacturing processes. The RTP chamber is normally tested for airflow velocity, particle counts, pressure decay of leakage, and sterility. The air flow balance of the RTP chamber is affected by the airflow quantity and the height above the platform. It is relatively easy to evaluate the RTP chamber's leakage by the pressure decay, where the system is charged with the air, closed, and the decay of pressure is measured by the time period. We conducted the determination of a vaporized H₂O₂ of a sufficient concentration to complete decontamination. The performance of the RTP chamber will improve safety and can be completely tested at an ISO Class 5 environment.
authors.affiliation: Department of Energy and Refrigerating Air-Conditioning Engineering, National Taipei University of Technology, Taipei 10608, Taiwan. schu.ntut@gmail.com.
authors.forename: Shih-Cheng
authors.initials: SC
authors.lastname: Hu
authors.affiliation: Department of Energy and Refrigerating Air-Conditioning Engineering, National Taipei University of Technology, Taipei 10608, Taiwan. angusshiue@gmail.com.
authors.forename: Angus
authors.initials: A
authors.lastname: Shiue
authors.affiliation: Air System Enterprise Co., Ltd., Taoyuan 326, Taiwan. asecoltd@ms27.hinet.net.
authors.forename: Han-Yang
authors.initials: HY
authors.lastname: Liu
authors.affiliation: Air System Enterprise Co., Ltd., Taoyuan 326, Taiwan. asentco@ms63.hinet.net.
authors.forename: Rong-Ben
authors.initials: RB
authors.lastname: Chiu
mesh_terms: D061808:Air Filters; D000395:Air Pollutants, Occupational / Q000032:analysis*; D016902:Air Pollution, Indoor / Q000032:analysis / Q000517:prevention & control*; D003666:Decontamination / Q000295:instrumentation / Q000379:methods*; D004340:Drug Contamination; D004345:Drug Industry; D006801:Humans; D006861:Hydrogen Peroxide / Q000032:analysis*; D016273:Occupational Exposure / Q000032:analysis / Q000517:prevention & control*; D014691:Ventilation / Q000295:instrumentation / Q000379:methods
chemical_list: D000395:Air Pollutants, Occupational; D006861:Hydrogen Peroxide
keywords: airflow pattern; cleanroom; contamination; particle image velocimetry; rapid transfer port