Results of microbial validation studies are filed with CFSAN in support of scheduled process filings. Sterilization procedures are often validated by placing resistant microbial spores on adhesive strips at strategic locations in equipment or on container materials. Packaging equipment and packaging materials are sterilized with various medium or combination of mediums (i.e., saturated steam, superheated steam, hydrogen peroxide and heat and other treatments). In addition, the processing and packaging system must be cleaned and re-sterilized before processing and/or packaging operations can resume.Īseptic processing equipment sterilization procedures often use steam or hot water under pressure. Any breach of a scheduled process for the processing or packaging system means that the affected product must be destroyed, reprocessed or segregated and held for further evaluation. the product sterilization system (hold tube) and all equipment downstream from the holding tube including the filler ĭocumentation of production operations must be maintained by the firm showing that commercially sterile conditions are achieved and maintained in all these areas.The major difference between aseptic processing and the more "conventional" types of LACF processing is that a process authority(s) must establish a process that ensures commercial sterility not only of the product but also for: Inspections of aseptic processing and packaging systems for Low Acid Canned Food (LACF) are some of the most complex inspections of food manufacturing operations. TABLE 1: ADVANTAGES AND DISADVANTAGES OF HEATING SYSTEMSįigure # 5: Scraped Surface Heat Exchangerįigure # 6: Superheated Steam Metal Container Systemįigure # 9: Preformed Cup System.pg. THERMOFORM-FILLED-SEAL CONATINERS-PRE-STERILIZED BY HEAT OR CO-EXTRUSION Scheduled Process for Reprocessed ProductsĬONTAINER STERILIZING, FILLING AND CLOSING OPERATIONS Clean-up and Re-Sterilization After Process Deviation
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