Aseptic processing

FffluentQuality. The criteria to be met by the effluent or filtrate must be clearly defined. Eor aseptic processes a typical requirement is sterilization through... 

A. Lopez, ed., A Complete Course in Canning Book II Packaging Aseptic Processing Ingredients, The Canning Trade, Inc., Baltimore, Md., 1987. 

Aseptic Processing and Packaging of Foods, lUFoST Symposium, Tylosand, Sweden, Sept. 1985. 

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. 

Aseptic processing systems have found wide use for packing juices and milk products for the retail market and for the bulk preservation of tomato paste and fmit sHces for use as ingredients. Further information on aseptic processing can be found in the Hterature (2). 

Aseptic harvesting is necessary to overcome the need for medium re-sterilisation before recycling. Sterilisation costs are high. If biomass can be recovered by an aseptic process, the medium can be recycled without re-sterilisation. This excludes centrifugation, which cannot be operated under aseptic conditions. 

Both fungi will grow at pH 2.5, at which non-aseptic processes can be operated (that is without sterilisation). However, the SCP grown in non-aseptic systems is suitable only as feed. The SCP from both organisms can be used as a high-protein food additive, but Fusarium sp. must be ground up (powdered) for this. In addition, the filamentous fungus can be used to make meat substitutes. For this the SCP must be prepared deep-frozen and not dried. 

Sterilization of the finished drug delivery formulation is an important consideration often overlooked in the early design of lactide/glycolide delivery systems. Aseptic processing and terminal sterilization are the two major routes of affording an acceptably sterile product. Both of these methods are suitable for products based on lactide/glycolide polymers if proper care is exercised in processing or selection of the treatment procedures. 

Aseptic processing is particularly useful with microencapsulated products, which almost always involve solutions of the polymer in organic solvents. Occasionally, bioactive molecules sensitive to... 

All laboratory operations are carried out in laminar flow cabinets in rooms in which filtered air is maintained at a slight positive pressure relative to their outer environment. Operators wear sterilized clothing and work aseptically. Antibiotic fermentations are, of strict necessity, pure culture aseptic processes, without con-tamirrating orgarrisms. 

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 ... 

The techniques discussed in this chapter comprise an attempt to achieve, as far as possible, the continuous monitoring of a particular sterilization process. The sterility test on its own provides no guarantee as to the sterility of a batch however, it is an additional check, and continued compliance with the test does give confidence as to the efficacy of a sterilization or aseptic process. Failure to carry out a sterility test, despite the major criticism of its inability to detect other than gross contamination, may have important legal and moral consequences. 

Schwartz, S.J. and Lorenzo, T.V., Chlorophyll stability during continuous aseptic processing and storage, J. Food Sci., 56, 1059, 1991. 

All production processes, such as ampoule washing and sterilization, solution filtration, equipment set-up and operation, sorting, and freeze-drier cleaning and operation, should be covered in detail in a procedure manual to ensure that all operations are understood as well as carried out properly and uniformly. Cleaning, sterilization, sterile filtration, filling, and aseptic processing operations must be validated. 

Particular attention should be paid to nonstandard production technologies including nonstandard methods of sterilization, sterile filtration and aseptic processing, lyophilization, microencapsulation, and certain critical mixing and coating operations. With such processes pilot-scale manufacture may not be predictive of industrial scale manufacture, and data on three full-scale production batches may be required in the application. 

Aqueous products moist heat at 121°C/15 minutes then moist heat to achieve a F0 value of not less than 8 minutes to achieve a sterility assurance level of 10 6 then aseptic filtration and aseptic processing then the use of presterilized components and aseptic compounding and assembly... 

Where terminal processing is not possible, the justification for alternative sterilization methods will be included in the EPAR, or at least a statement to the effect that sterile filtration/aseptic processing will be used. Presterilization bioburden issues that arose during the assessment will be included in the EPAR. 

Aseptic Core (Grade A) Aseptic Process Area (Grade B) Clean Preparation Area (Grade C) Support Area (Grade D)... 

The production of drugs under GMP conditions is costly, especially for protein-based drugs, which require aseptic processes. Manufacturers have looked to... 

The BFS technology is an advanced aseptic processing technique which allows plastic containers to be formed by means of molded extruded polymer granules, filled, and sealed in one continuous process. This differs from conventional aseptic processing where container formation, preparation, and sterilization, and container filling and closiu e are all separate processes. 

---