Aseptic processing principles

P. E. Nelson, J. V. Chambers, andj. H. Rodrigue2, eds.. Principles of Aseptic Processing and Packaging The Eood Processors Institute, Washington, D.C., 1987. PackAlimentaire 89 Conference, Schotiand Business Research, Inc., Princeton, N.J., 1989. 

Instruction on the basic principles of microbiology, microbial physiology, disinfection and sanitation, media selection and preparation, taxonomy, and sterilization as required by the nature of personnel involvement in aseptic processing... 

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

Aseptic Assembly. The first interventions performed are those that prepare the equipment for the aseptic process. This entails the removal of sterilized materials and equipment items from the autoclave and transfer to the location where the aseptic processing activities will be performed. This is ordinarily followed by the assembly/preparation of the equipment for the process. Aseptic assembly in which sterilized parts are removed from protective materials, installed and adjusted in preparation for the aseptic process are perhaps the most potentially invasive of all of the activities which must be performed. The operator must be meticulous in their execution of these tasks to prevent the inadvertent contamination of product contact surfaces. Strict adherence to the principles of aseptic technique described earlier is essential. These interventions are a necessary part of every aseptic activity, and it is common to identify the first containers filled as they may be more indicative of potential problems with the aseptic assembly. For this reason, the validation program should include process simulations that include containers filled immediately after the set-up of the equipment. 

The regulatory requirements for validation of pharmaceutical aseptic processes are clear. Generally accepted quality assurance principles require initial... 

The impact of the proposal may reopen a debate on the way in which SALs appear to be applied to aseptic processing. The origins of the SAL concept lie in terminal sterilization and rest heavily on the extrapolated effects of uniform sterilization treatments to populations of contaminants defined in terms of resistance and of numbers of contaminants (biobuiden). The process of aseptic manufacture is a process of contamination control the frequency of occurrence of a contaminated item within a population of aseptically filled items is a measure of bioburden, not a measure of the SAL. The SAL is the probability of those contaminants surviving, and this is a function of the types of contaminants and the formulation of the product. Formulations can be made to be antimicrobial. In principle this is no different from chemical sterilization. 

Although aseptic handling differs significantly from aseptic processing, the principles for microbiological controls, like monitoring and process validation, are the same. As most aseptic work is done manually, the aseptic technique of the operators has to be checked with additional microbiological controls. 

Nelson, Philip E., ed. Principles of Aseptic Processing and Packaging. 3d ed. Lafeyette, Ind. Purdue University Press, 2010. A technical discussion of aseptic manufecturing methods and applications and government regulations establishing guidelines. 

The chemometric principle was used to derive a guideline for obtaining a simple yes or no answer about the sterility of food particulates heated at aseptic processing temperatures. A quadratic temperature pulse model was used to estimate bacterial destruction from the fractional yield of thermally produced chemical marker compounds (2,3-dihydro-3,5-dihydroxy-6-methyl-4(H)-pyran-4-one, M-1, and 4-hydroxy-5-methyl-3(2H)-furanone, M-2) and the rate constants and the activation energies of the chemical and bacterial systems. The model yielded a conservative estimate of lethality at the center of meat-balls heated under different time-temperature conditions. A scheme for determining the minimum marker yield for a designated F -value is provided. 

As is the case with all other pharmaceutical substances, all aspects of antisera production must be undertaken by means conducive to the principles of GMP. Most regulatory authorities publish guidelines which outline acceptable standards/procedures for the production of such blood-derived products. Donor animals must be healthy and screened for the presence of (particularly blood-borne) pathogens. They must be housed in appropriate animal facilities, and withdrawal of blood must be undertaken by aseptic technique. Subsequent downstream processing must be undertaken according to the principles of GMP, as laid down in Chapter 3. 

Rose, D., 1985, Guidelines for the processing and aseptic packaging of low acid foods. Part 1. Principles of design installation and commissioning. Campden Food Preservation Research Association. Chipping Campden. 

The underlying principles for premises for non-sterile stock preparations should be used for extemporaneous preparations as well. Preparation activities in a community pharmacy usually are confined to reconstitution, aseptic handling, manipulation of licensed medical products and non-sterile preparation firom raw materials. The avoidance of crossing process lines in small-scale situations is a... 

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