| Specifications | Processing in Steam in Still Reports FORM FDA 3511a PSC Graphics |
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| Specifications | Processing in Steam in Still Reports FORM FDA 3511a PSC Graphics |
| Business section |
| Specifications | Processing in Steam in Still Reports FORM FDA 3511a PSC Graphics |
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| Content | FORM FDA 3511a (7/10)PAGE 1 of 10 Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: RETORT DESCRIPTION PROCESSING IN STEAM IN STILL RETORTS (Retort Survey) DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION INSTRUCTIONS 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 and attach it to the EIR as an exhibit. Measure and verify retort plumbing – record on this form. Report all pipe sizes as inside diameter (ID). 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. RETORT NO.TYPE OF RETORT Vertical Horizontal LENGTH OR HEIGHTDIAMETER FOR VERTICAL RETORTS, BOTTOM CRATE SUPPORTS ARE PRESENT. (SHALL REQUIREMENT) COMMENTS: ARE BAFFLE PLATES PRESENT IN THE BOTTOM OF THE RETORT? (SHALL NOT BE USED IN THE BOTTOM OF STEAM STILL RETORTS (113.40(a)(6)) – BAFFLE PLATES ARE UNDESIRABLE IN THE BOTTOM OF STILL STEAM RETORTS BECAUSE THEY CAN IMPEDE THE FLOW OF STEAM FROM STEAM INLETS OR PERFORATED STEAM DISTRIBUTOR PIPES.) COMMENTS: ARE THERE ANY PROTRUSIONS INSIDE THE RETORT OR THE RETORT DOOR CASING THAT COULD DAMAGE CONTAINERS DURING LOADING/UNLOADING OF CRATES? COMMENTS: COMPUTER CONTROLS DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? COMMENTS: PSC Graphics (301) 443-1090 EF .No Yes . YesNo . No Yes .No Yes |
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| Following Datasheets | UCM071581_1 (9 pages) UCM071587_1 (11 pages) UCM071605_1 (8 pages) UCM071615_1 (11 pages) UCM071640_1 (7 pages) UCM071653_1 (11 pages) UCM071661_1 (11 pages) UCM071670_1 (7 pages) UCM071977_1 (6 pages) UCM072017_1 (1 pages) |
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