{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T20:03:53Z","timestamp":1762459433670,"version":"build-2065373602"},"reference-count":27,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2016,11,12]],"date-time":"2016-11-12T00:00:00Z","timestamp":1478908800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJERPH"],"abstract":"<jats:p>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\u2032s 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.<\/jats:p>","DOI":"10.3390\/ijerph13111129","type":"journal-article","created":{"date-parts":[[2016,11,14]],"date-time":"2016-11-14T11:39:50Z","timestamp":1479123590000},"page":"1129","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Validation of Contamination Control in Rapid Transfer Port Chambers for Pharmaceutical Manufacturing Processes"],"prefix":"10.3390","volume":"13","author":[{"given":"Shih-Cheng","family":"Hu","sequence":"first","affiliation":[{"name":"Department of Energy and Refrigerating Air-Conditioning Engineering, National Taipei University of Technology, Taipei 10608, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angus","family":"Shiue","sequence":"additional","affiliation":[{"name":"Department of Energy and Refrigerating Air-Conditioning Engineering, National Taipei University of Technology, Taipei 10608, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Han-Yang","family":"Liu","sequence":"additional","affiliation":[{"name":"Air System Enterprise Co., Ltd., Taoyuan 326, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rong-Ben","family":"Chiu","sequence":"additional","affiliation":[{"name":"Air System Enterprise Co., Ltd., Taoyuan 326, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2016,11,12]]},"reference":[{"key":"ref_1","unstructured":"ISO 14644-1 Cleanrooms and Associated Controlled Environments\u2014Part 1: Classification of Air Cleanliness. Available online: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14644:-1:ed-1:v1:en."},{"key":"ref_2","unstructured":"Bioquell Inc. Bio-Decontamination of Material Transfer Systems. Available online: http:\/\/www.pharmaceuticalonline.com\/doc\/bio-decontamination-material-transfer-systems-0001."},{"key":"ref_3","first-page":"113","article-title":"Use of the HACCP concept for the risk analysis of pharmaceutical manufacturing processes","volume":"2","author":"Jahnke","year":"1997","journal-title":"Eur. J. Parenter. Pharm. Sci."},{"key":"ref_4","first-page":"43","article-title":"The use of a risk assessment in the pharmaceutical industry\u2014The application of FMEA to a sterility testing isolator: A case study","volume":"8","author":"Sandle","year":"2003","journal-title":"Eur. J. Parenter. Pharm. Sci."},{"key":"ref_5","first-page":"32","article-title":"The validation of a rapid sterile transfer port (RsTP) system used in barrier filling lines\u2014An Improved Strategy for Materials Handling in the Pharmaceutical Industry","volume":"27","author":"Tingley","year":"2003","journal-title":"Pharm. Technol."},{"key":"ref_6","first-page":"1","article-title":"Current Practices in the Validation of Aseptic Processing 2001. Technical Report No. 36, PDA","volume":"56","author":"Agalloco","year":"2002","journal-title":"J. Pharm. Sci. Technol."},{"key":"ref_7","unstructured":"Michael, A., Szatmary, F.T., and Worth, T.X. (2004). Rapid Transfer Port. (6779567 B1), U.S. Patent."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"6777","DOI":"10.1016\/j.vaccine.2009.08.056","article-title":"Measurement of neutralizing antibody responses against H5N1 clades in immunized mice and ferrets using pseudotypes expressing influenza hemagglutinin and neuraminidase","volume":"27","author":"Tsai","year":"2009","journal-title":"Vaccine"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1305","DOI":"10.3168\/jds.S0022-0302(92)77881-3","article-title":"Ventilation system to minimize airborne bacteria, dust, humidity, and ammonia in calf nurseries","volume":"75","author":"Hillman","year":"1992","journal-title":"J. Dairy Sci."},{"key":"ref_10","unstructured":"Allen, J.R., Burgess, M., and Aiken, S.C. (2009). Container Lid Gasket Protective Strip for Double Door Transfer System. (0212054 A1), U.S. Patent."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1128\/CMR.4.2.207","article-title":"Biological safety cabinetry","volume":"4","author":"Kruse","year":"1991","journal-title":"Clin. Microbiol. Rev."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1017\/S0950268800048780","article-title":"Physical protection against airborne pathogens and pollutants by a novel animal isolator in a level 3 containment laboratory","volume":"107","author":"Wathes","year":"1991","journal-title":"Epidemiol. Infect."},{"key":"ref_13","unstructured":"Huang, R. (2005). Isolator of Using Negative Pressure for Big Animals. (1625942A), CN Patent Publication."},{"key":"ref_14","unstructured":"Tattershall, S.F. (2006). Enclosure for Handling Hazardous Material. (7077486 B2), U.S. Patent."},{"key":"ref_15","unstructured":"Advisory Committee on Dangerous Pathogens (1983). Categorisation of Pathogens According to Hazard and Categories of Containment."},{"key":"ref_16","unstructured":"Runkle, R.S., Allendale, N.J., Marsh, R.C., and Albuquerque, N.M. (1969). Unit for Providing Environmental Control of Animals. (3630174), U.S. Patent."},{"key":"ref_17","unstructured":"ISO 14644-7 Cleanrooms and Associated Controlled Environments\u2014Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini Environments) 2004. Available online: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14644:-7:ed-1:v1:en."},{"key":"ref_18","unstructured":"ISO 10648-2 Containment Enclosures\u2014Part 2: Classification According to Leak Tightness and Associated Checking Methods, Available online: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:10648:-2:ed-1:v1:en."},{"key":"ref_19","unstructured":"ASTM E2930 Standard Practice for Pressure Decay Leak Test Method 2013. Available online: https:\/\/www.astm.org\/Standards\/E2930.htm."},{"key":"ref_20","unstructured":"ISO 14644-3 Cleanrooms and Associated Controlled Environments\u2014Part 3 Test Methods, B.4 Airflow Test 2005. Available online: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14644:-3:ed-1:v1:en."},{"key":"ref_21","unstructured":"ISO 14644-3 Cleanrooms and Associated Controlled Environments\u2014Part 3 Test Methods, B.13 Containment Leak Test 2005. Available online: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14644:-3:ed-1:v1:en."},{"key":"ref_22","unstructured":"ISO 14644-3 Cleanrooms and Associated Controlled Environments\u2014Part 3 Test Methods, B.5 Air Pressure Difference Test 2005. Available online: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14644:-3:ed-1:v1:en."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Doyle, D.F. (2013). Gas System Leakage Pressure Decay. J. Pressure Vessel Technol.","DOI":"10.1115\/1.4007190"},{"key":"ref_24","unstructured":"Baumeister, T., Avallone, E.A., and Baumeister, T. (1978). Marks Mechanical Engineering Handbook, McGraw Hill Co.. [8th ed.]."},{"key":"ref_25","unstructured":"ISO 14644-3 Cleanrooms and Associated Controlled Environments Part 3 Test Methods, C.4 Airflow Test 2005. Available online: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14644:-3:ed-1:v1:en."},{"key":"ref_26","unstructured":"USP 797: Pharmaceutical Labs & Sterile Compounding. Available online: http:\/\/www.portafab.com\/usp-797."},{"key":"ref_27","unstructured":"Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u2014Current Good Manufacturing Practice, Available online: http:\/\/www.fda.gov\/downloads\/Drugs\/...\/Guidances\/ucm070342.pdf."}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/13\/11\/1129\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T19:35:25Z","timestamp":1760211325000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/13\/11\/1129"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,11,12]]},"references-count":27,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2016,11]]}},"alternative-id":["ijerph13111129"],"URL":"https:\/\/doi.org\/10.3390\/ijerph13111129","relation":{},"ISSN":["1660-4601"],"issn-type":[{"type":"electronic","value":"1660-4601"}],"subject":[],"published":{"date-parts":[[2016,11,12]]}}}