Processing Equipment Audits

IEH staff can conduct a complete process equipment audit of food processing and pharmaceutical manufacturing facilities. Both FDA and USDA/FSIS have certain equipment requirements and/or recommendations that manufacturers must or should meet. IEH will evaluate the process equipment to make sure clients produce a safe and wholesome product.
For many clients, the thermal process, aseptic process or sterilization procedures are the most important unit operation of producing a product. IEH will thoroughly evaluate the retort, autoclave, aseptic processing, or aseptic packaging system to determine if the systems are in compliance with all pertinent FDA and/or USDA/FSIS regulations and that the equipment will not produce an under-processed or adulterated product.

IEH will evaluate product batching equipment and instrumentation, product conveying systems, product warehousing systems, and, most importantly, the product sterilization systems. The design of piping and valving pathways that convey product, ingredients or other utilities; the sterile zones of aseptic processes or fillers will be evaluated for the appropriateness of design and the soundness of concept. Special attention will be given to inspecting equipment components or areas that affect critical product or process parameters.

IEH will also evaluate FDA product process filings, when applicable, and ascertain if all system critical factors have been identified. In addition, operating guidelines documents for retort/autoclave or aseptic processing and aseptic packaging systems willbe reviewed.
After completion of the audit, IEH will issue a detailed report with comments and recommendations and follow-up with a phone call for additional discussion of the findings and recommendations.