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Some observations on airborne particles in the pharmaceutical blow-fill-seal environment
KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
2009 (English)Licentiate thesis, comprehensive summary (Other academic)
Place, publisher, year, edition, pages
Stockholm: KTH , 2009. , 112 p.
Series
Meddelande. Installationsteknik, 72
Identifiers
URN: urn:nbn:se:kth:diva-10533OAI: oai:DiVA.org:kth-10533DiVA: diva2:218890
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
List of papers
1. Some observations on airborne particles in blow-fill-seal filling rooms
Open this publication in new window or tab >>Some observations on airborne particles in blow-fill-seal filling rooms
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.

Keyword
Airborne particles, Aseptic filling, Blow-fill-seal
National Category
Civil Engineering
Identifiers
urn:nbn:se:kth:diva-25729 (URN)17722481 (PubMedID)2-s2.0-34547736423 (Scopus ID)
Note
QC 20101029Available from: 2010-10-29 Created: 2010-10-29 Last updated: 2017-12-12Bibliographically approved
2. Some observations on airborne particles in the critical areas of a blow-fill-seal machine
Open this publication in new window or tab >>Some observations on airborne particles in the critical areas of a blow-fill-seal machine
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.

Keyword
Airborne particles, Aseptic filling, Blow-fill-seal
National Category
Civil Engineering
Identifiers
urn:nbn:se:kth:diva-25735 (URN)19455943 (PubMedID)2-s2.0-66349134725 (Scopus ID)
Note
QC 20101029Available from: 2010-10-29 Created: 2010-10-29 Last updated: 2017-12-12Bibliographically approved

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