Challenges to a blow/fill/seal process with airborne microorganisms having different resistances to dry heat.

Controlled challenges with air dispersed microorganisms having widely different resistances to dry heat, carried out on 624 BFS machine processing growth medium, have shown that higher the heat resistance, the greater the extent of vial contamination. Differences in heat resistance affected also the extent of vial contamination when parison and vial formation were knowingly manipulated through changes made to each of three process variables, provision of ballooning air, mould vacuum delay, and parison extrusion rate. The findings demonstrate that, in this investigational system, exposure of challenge micoorganisms to heat inherent in the process has a controlling influence on vial contamination, an influence that could also control microbiological risk in production environments.

Impact of Blow/Fill/Seal process variables in determining rate of vial contamination by air dispersed microorganisms.

Controlled challenges of air dispersed spores of Bacillus subtilis NCIMB 8649 have been generated in a custom-built challenge room housing a Blow/Fill/Seal machine filling filter-sterilized trypticase soy broth into 5.5 cm3 low density polyethylene vials. The effects on the rate of vial contamination of systematic changes in the process variables, rate of provision of ballooning air, delay in the application of mould vacuum and duration of transfer of the open vial, have been examined.

Design, development and qualification of a microbiological challenge facility to assess the effectiveness of BFS aseptic processing.

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.

Evaluation of Blow/Fill/Seal extrusion through processing polymer contaminated with bacterial spores and endotoxin.

A study has been carried out to further the understanding of the extrusion process and its impact upon the quality of Blow/Fill/Seal product. Controlled challenges to the extrusion system, comprising low-density polyethylene granulate contaminated with characterized levels of Bacillus atrophaeus (ATCC 9372) endospores and Escherichia coli 055:B5 bacterial endotoxin, have been conducted. Batches of spore contaminated polymer, at challenge levels varying from 10(3) to 10(6) spores g(-1) polymer with derived D160 values ranging from 1.

Air Sampling System for use in monitoring viable and non-viable particulate air quality under dynamic operating conditions of blow/fill/seal processing.

An Air Sampling Link (ASL), employed in conjunction with an Air Sampling Device (ASD) or a laser particle counter, has been developed for sampling flowing air for viable and non-viable particulate analyses. Typically, the ASL could be used to sample filtered air supplied to an air shower of a Blow/Fill/Seal machine operating in the dynamic state. The ASL allows sample volumes of air to be taken from flowing air without significant loss from the sample flow of airborne particles possessing aerodynamic sizes relevant to those found in practice.