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Loading and unloading of freeze-dryers: Airborne contamination risks for aseptically manufactured sterile drug products
KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
2007 (English)In: PDA journal of pharmaceutical science and technology, ISSN 1079-7440, E-ISSN 1948-2124, Vol. 61, no 1, 44-50 p.Article in journal (Refereed) Published
Abstract [en]

In pharmaceutical manufacturing, freeze-drying processes can be adversely affected by temperature differences relative to the surrounding air. Loading and unloading of freeze-dryers are performed either without or with temperature differences between the cleanroom and the chamber of the freeze-dryer. This operation can cause a flow of room air through the opening, creating a contamination risk, especially when manual handling of material is performed in this area. To minimize this risk, a high-efficiency particulate air (HEPA) filter unit should be installed above the opening to provide clean air and protect the opening. Here the theoretical relationships are discussed and design criteria are presented.

Place, publisher, year, edition, pages
2007. Vol. 61, no 1, 44-50 p.
Keyword [en]
Airborne contamination, Aseptic loading/unloading, Contamination risks, Freeze-dryer
National Category
Engineering and Technology
Identifiers
URN: urn:nbn:se:kth:diva-75224PubMedID: 17390703Scopus ID: 2-s2.0-33847609165OAI: oai:DiVA.org:kth-75224DiVA: diva2:490340
Note
QC 20120302Available from: 2012-02-05 Created: 2012-02-05 Last updated: 2017-12-08Bibliographically approved

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