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Int. J. Environ. Res. Public Health 2016, 13(11), 1129; doi:10.3390/ijerph13111129

Validation of Contamination Control in Rapid Transfer Port Chambers for Pharmaceutical Manufacturing Processes

1
Department of Energy and Refrigerating Air-Conditioning Engineering, National Taipei University of Technology, Taipei 10608, Taiwan
2
Air System Enterprise Co., Ltd., Taoyuan 326, Taiwan
*
Author to whom correspondence should be addressed.
Academic Editor: Yu-Pin Lin
Received: 18 September 2016 / Revised: 2 November 2016 / Accepted: 8 November 2016 / Published: 12 November 2016
View Full-Text   |   Download PDF [1575 KB, uploaded 12 November 2016]   |  

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. View Full-Text
Keywords: rapid transfer port; contamination; cleanroom; airflow pattern; particle image velocimetry rapid transfer port; contamination; cleanroom; airflow pattern; particle image velocimetry
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MDPI and ACS Style

Hu, S.-C.; Shiue, A.; Liu, H.-Y.; Chiu, R.-B. Validation of Contamination Control in Rapid Transfer Port Chambers for Pharmaceutical Manufacturing Processes. Int. J. Environ. Res. Public Health 2016, 13, 1129.

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