Processing in Water in Discontinuous Agitating Retorts \Retort Survey\ FORM FDA 3511e PSC Graphics

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Specifications	Processing in Water in Discontinuous Agitating Retorts \Retort Survey\ FORM FDA 3511e PSC Graphics
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FORM FDA 3511e (1/11)PAGE 1 of 11 COMPUTER CONTROLS DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? EXPLAIN: DOES THE FI

Specifications	Processing in Water in Discontinuous Agitating Retorts \Retort Survey\ FORM FDA 3511e PSC Graphics
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Content	FORM FDA 3511e (1/11)PAGE 1 of 11 COMPUTER CONTROLS DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? EXPLAIN: DOES THE FIRM HAVE DOCUMENTATION ON HAND WHICH INDICATES THAT THE COMPUTER SYSTEM HAS BEEN VALIDATED? EXPLAIN: IS RECORD KEEPING PART OF THE COMPUTER FUNCTION? IF YES, DOES THE RECORD KEEPING COMPLY WITH 21 CFR PART 11? COMMENTS: PSC Publishing Services (301) 443-6740 EF INSTRUCTIONS This report covers batch-type agitating retort systems pressure processing in water with overriding air or steam. This includes the traditional rotating systems specifically covered under 113.40(e) as well as other axial and end-over-end processing systems covered by 113.40(j), “Other Systems.” Complete the question blocks below. Narrative responses to each item can be entered in the item’s “comments” area or where otherwise prompted. Draw a diagram of the retort or obtain one from the firm. Attach the diagram to the EIR as an exhibit. Measure and verify retort plumbing – record on this form. Report all pipe sizes as inside diameter (ID). Refer to 21 CFR Part 113.40(e) and pp. 32-34 of LACF Guide, Part 2. Before entering the interior of the retort, you must confirm with the firm that you are following the firm’s Standard Operating Procedures designed to meet OSHA confined space requirements. If the firm insists that only plant personnel enter the retort, witness the measurement procedure and data collection. To obtain OSHA confined space information and safety procedures, see the confined space presentation on the FDA ORAU web site. If the firm is not aware of the OSHA confined space requirements or does not have a confined space program, DO NOT ENTER THE RETORT. If problems are found with the firm’s retort equipment or processing system, refer the reader to the Turbo EIR for a narrative description of specific problems with supporting evidence, under “Objectionable Conditions and Management’s Response.” Submit the completed form as an EIR attachment. PROCESSING IN WATER IN DISCONTINUOUS AGITATING RETORTS (Retort Survey) DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PROCESSING MODE Axial End-over-End RETORT NO. & DIMENSIONSCAN SIZECOOKER CAPACITYSTEPS/REEL List the can size covered during the inspection. RETORT DESCRIPTION Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: YesNo . YesNo . YesNo . No Yes.
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Following Datasheets	UCM071640_1 (7 pages) UCM071653_1 (11 pages) UCM071661_1 (11 pages) UCM071670_1 (7 pages) UCM071977_1 (6 pages) UCM072017_1 (1 pages) UCM072080_1 (1 pages) UCM072759_1 (2 pages) UCM072770_1 (1 pages) UCM072772_1 (1 pages)
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