Aseptic processing source

Surprisingly little is known about the resistance of yeasts, fungi and fungal spores to disinfeetants and preservatives. They are a major source of potential contamination in pharmaceutical product preparation and aseptic processing since they abound in the environment. It is, however, possible to make some general observations ... 

Instmction on the basic principles of aseptic processing and the relationship of manufacturing and handling procedures to potential sources of product contamination... 

The major source of microbial contamination of controlled environments is personnel. Since the major threat of contamination of product being aseptically processed comes from the operating personnel, the control of microbial contamination associated with these personnel is one of the most important elements of the environmental control program. Personnel training should be conducted before the qualification and validation practice [13]. 

It is common practice for firms to interrupt their aseptic processes when atypical total particulate excursions are observed so that the scientists and engineers can determine the source of the foreign material. Monitoring frequency and expectations in the less critical environments is always reduced relative to the critical aseptic environments. 

Table 1 Most likely sources of microbial contamination in aseptic processing ...

Although this procedure is necessary for production of samples of pure virions it is usually unnecessary if a viral preparation is only required for subsequent infections. In such circumstances the cells should be harvested aseptically and processed to step e, omitting the DNase and RNase. The debris from the disrupted cells is pelleted at 15,000g for 30 min and the supernatant used as a source of virus. It should be tested for bacterial contamination with brain-heart infusion broth and Saboraud fluid medium (Appendix 4). The virus should be stored at -70°C at about 1010 p.f.u./ml. 

Scharpf et al extensively review the production of aroma compounds by fermentation processes. Of particular interest to those interested in this technology is the discussion on the factors to be considered in scale-up and the potential problems. They conclude that aseptic fermentation is appropriate when the product has a value of 100 to 800 per kg. They describe and reference a issued patented procedure for the production of y-decalactone by aseptic fermentation using castor oil as the carbon source. 

To control these sources of contamination, the critical processes of aseptic filling are done on machines or at work stations that have been designed to protect the previously cleaned and sterilized components from contamination. These work stations or filling machines must themselves be located in contamination-protected areas. These are usually clean rooms. 

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