Aseptic filling broth fill contamination

There is no appropriate defined sterility confidence level which can be translated directly into acceptance criteria for broth fill contamination for BFS processes. The most commonly recognized acceptance criterion is a sterility assurance level (SAL) of 10 although modem aseptic filling techniques such as BFS can achieve a higher SAL. This should be reflected by broth fill results and acceptance criteria for this advanced technology. 

Prequency and size of broth fills must be clearly defined. The size of fill is usually based upon the statistical probability of detecting an acceptably low incidence of microbial contamination. Tables have been published to this effect [4], but the BPS operator has to decide both size and frequency of broth fills based upon their speeifie facility, routine product batch sizes, and operation. Por high speed BPS maehines used for filling routine produet batehes in excess of 100,000 units, broth fill batehes larger than traditional aseptic filling lines are both feasible and appropriate. 

Broth fills should be carried out under conditions that are representative of those during normal operation. If there is to be a deviation from routine processes, it should only be in the direction of presenting a greater, rather than a lesser, challenge to the process. Due to the level of automation of BFS technology, it is extremely difficult to take extra care in order to reduce the chance of container contamination during a broth fill therefore, results are not as operator-dependent as other less automated aseptic manufacturing processes. 

The broth fill is a validation procedure that challenges both operator and facilities. The purpose of broth fills is to simulate routine aseptic operations in such a way as to produce broth filled units that can be tested for microbiological contamination. 

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