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Some observations on airborne particles in blow-fill-seal filling rooms
KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
2007 (English)In: PDA journal of pharmaceutical science and technology, ISSN 1079-7440, E-ISSN 1948-2124, Vol. 61, no 3, 147-153 p.Article in journal (Refereed) Published
Abstract [en]

Pharmaceutical products produced by blow-fill-seal (BFS) technology are manufactured in clean rooms of different cleanliness classes. Regulatory authorities set requirements on factors such as the maximum allowed airborne particle concentration in filling rooms with BFS machines. To meet the requirements of the authorities, the supply air is HEPA-filtered. The necessary flow of HEPA-filtered air depends on the particle generations from the BFS machines (source strength). One method of reducing the airborne particle concentration in the filling rooms is to install local exhaust systems in order to remove generated particles. Knowledge of particle dispersion and source strength are necessary to enable correctly dimensioned airflows. In this paper, the dispersion pattern of particles was studied at one filling machine. The partial source strength was determined for four different filling machines. The source strength is the total number of airborne particles per second generated by the BFS machine and the process. The value of the partial source strength will be dependent on the efficiency of the local exhaust system. Partial source strength is defined as the estimated theoretical quantity of particles per second emitted from the filling machine into the filling room. The results show that the partial source strength varies widely between the different filling machines. The source strength levels vary between 102 and 10 7 particles (≥ 0.5 μm) per second. Furthermore, the results show that the efficiency of the local exhausts can be improved by design adjustments.

Place, publisher, year, edition, pages
2007. Vol. 61, no 3, 147-153 p.
Keyword [en]
Airborne particles, Aseptic filling, Blow-fill-seal
National Category
Civil Engineering
Identifiers
URN: urn:nbn:se:kth:diva-25729PubMedID: 17722481Scopus ID: 2-s2.0-34547736423OAI: oai:DiVA.org:kth-25729DiVA: diva2:359668
Note
QC 20101029Available from: 2010-10-29 Created: 2010-10-29 Last updated: 2017-12-12Bibliographically approved
In thesis
1. Some observations on airborne particles in the pharmaceutical blow-fill-seal environment
Open this publication in new window or tab >>Some observations on airborne particles in the pharmaceutical blow-fill-seal environment
2009 (English)Licentiate thesis, comprehensive summary (Other academic)
Place, publisher, year, edition, pages
Stockholm: KTH, 2009. 112 p.
Series
Meddelande. Installationsteknik, 72
Identifiers
urn:nbn:se:kth:diva-10533 (URN)
Presentation
2009-04-06, V1, KTH, Teknikringen 76, Stockholm, 13:00 (English)
Opponent
Supervisors
Available from: 2009-05-25 Created: 2009-05-25 Last updated: 2010-10-29Bibliographically approved
2. Airborne Contaminants in the Pharmaceutical Blow-Fill-Seal Environment
Open this publication in new window or tab >>Airborne Contaminants in the Pharmaceutical Blow-Fill-Seal Environment
2010 (English)Doctoral thesis, comprehensive summary (Other academic)
Place, publisher, year, edition, pages
Stockholm: KTH, 2010. 151 p.
Identifiers
urn:nbn:se:kth:diva-27388 (URN)
Public defence
2010-12-15, V1, Teknikringen 76, KTH, Stockholm, 14:00 (English)
Opponent
Supervisors
Note
QC 20101213Available from: 2010-12-13 Created: 2010-12-13 Last updated: 2010-12-13Bibliographically approved

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