A programme of work has been initiated to further the understanding of the impact of the environment surrounding a Blow/Fill/Seal (BFS) machine upon the microbiological quality of processed product. A dedicated facility (Challenge Room) has been constructed and qualified to provide for the production and containment of dispersions of micro organisms in air of a room housing an operating BFS machine of a given style and configuration. The facility achieves homogeneous distribution of generated dispersions throughout the Challenge Room air, including that within and close to the critical area in which aseptic BFS operations occur. Generated microbial dispersions can be maintained in the room over extended time periods (up to 600 min) at a desired concentration within the range 10(1) to 10(7) cfu m(-3). They can also be produced employing different cell types, including bacterial endospores, Gram-positive and Gram-negative vegetative cells and yeast cells. Effective containment of dispersions is achieved while 'cards of product' (vials in sets) are conveyed from the Challenge Room to an adjacent Packing and Storage Area. Decontamination of the room and the housed BFS machine is accomplished through exposure to chlorine dioxide gas at a concentration of 1.0 mg dm(-3) for 120 min at room temperature (approximately 23 degrees C).

Air Microbiology↗

PubMedDate not supplied

Airborne microbial challenges of Blow/Fill/Seal equipment: a case study.

Controlled microbial challenges, comprising air-dispersed spores of Bacillus subtilis var niger, have been generated within a containment room (around 54 m3 in volume) housing a Blow/Fill/Seal machine. 'Stirred-settling' conditions were created throughout the room and the airborne spore challenge was monitored to ensure homogeneity within the room for extended periods of time. The Blow/Fill/Seal machine was set to fill 2 cm3 ampoules with Tryptone Soya Broth at each of three airborne challenge levels of 10(4), 10(6) and 10(7) spores m-3 (about 10(2), 10(4) and 10(5) spores ft-3 respectively). A relationship has been established between the level of airborne micro-organisms in the machine operating environment and the extent of product contamination. This relationship allows prediction of operating conditions under which a level of sterility assurance, equal to that demanded of terminal sterilization, is attained. It is stressed that the findings apply only to the particular Blow/Fill/Seal machine and to the specific conditions of machine operation.

Air Microbiology↗

PubMedDate not supplied

Performance of blow/fill/seal equipment under controlled airborne microbial challenges.

Fundamental investigations have been carried out into the effectiveness of aseptic fill using Blow/Fill/Seal machinery. Techniques have been developed to generate and to maintain over prolonged periods, controlled microbial challenges of spores of Bacillus subtilis var. niger dispersed within the air of a containment room housing a Blow/Fill/Seal machine set-up to undertake medium fill studies. The range of spore concentrations that have been generated extends from as low as 3 x 10(2) to as high as 10(7) spores m-3. Responses to controlled microbial challenges have defined the relationship between product contamination and microbiological quality of the machine environment. The relationship is regular and amenable to extrapolation, so that it is now practicable to specify the microbiological quality of the machine environment, together with machine operating conditions, needed to attain a Sterility Assurance Level comparable to that targeted for terminal sterilization (i.e. 10(-6)). The impacts of mould configuration, air shower operation and location of point of fill on product contamination have also been examined.

Air Microbiology↗

PubMedDate not supplied

Blow/fill/seal process.

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Air Microbiology↗