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Some observations on airborne particles in the critical areas of a blow-fill-seal machine
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.
2009 (English)In: PDA journal of pharmaceutical science and technology, ISSN 1079-7440, E-ISSN 1948-2124, Vol. 63, no 1, 71-80 p.Article in journal (Refereed) Published
Abstract [en]

Regulatory authorities set requirements on factors such as maximum allowed airborne particle concentrations in critical areas and the surrounded environment. An important issue when producing sterile drugs by aseptic processing with blow-fill-seal technology is to achieve Class 100 (ISO Class 5) in the critical area. To meet these requirements high efficiency particulate air (HEPA)-filtered airflow is used to dilute and remove airborne particles. The required airflow is dependent on the quantity of generated particles. The purpose of this paper is to present the measures taken to reduce airborne particle concentrations at critical areas of a blow-fill-seal machine. The methods being used in the experimental studies are smoke visualization and particle measurements. The results show that particle concentrations can be reduced by minor changes of process variables. By changing the process variables, particle concentrations - number of particles (≥0.5 μm) per cubic foot - in the shroud (filling zone), extrusion zone, and the filling room were approximately reduced as follows: ∼90% in the shroud (filling zone), ∼90% in the extrusion zone, and ∼40-60% in the filling room. It should be noted that the presented results are limited to one type of blow-fill-seal machine and this paper is a continuation of an earlier published paper by the authors in the PDA journal.

Place, publisher, year, edition, pages
2009. Vol. 63, no 1, 71-80 p.
Keyword [en]
Airborne particles, Aseptic filling, Blow-fill-seal
National Category
Civil Engineering
Identifiers
URN: urn:nbn:se:kth:diva-25735PubMedID: 19455943Scopus ID: 2-s2.0-66349134725OAI: oai:DiVA.org:kth-25735DiVA: diva2:359670
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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