Manufacturers - 2

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2. Drain valve, type, screened.
3. Water level indicators, type, use.
4. Air supply and control.
5. Method of water circulation, compliance with regulations, temperature distribution studies.
6. Cooling water supply.
7. Location of control temperature sensing probe.
3. Continuous agitating steam retorts
   1. Capacity and number of steps in reel.
   2. Vents and bleeders specifications and locations.
   3. Method of removing condensate, condensate bleeder.
   4. Retort speed timing method and frequency, tamper proof.
   5. Procedures for handling emergency stops and temperature drops.
4. Discontinuous agitating steam retorts
   1. Capacity and number of steps in reel.
   2. Retort speed timing method and frequency.
   3. Procedures for removing condensate.
   4. Vents and bleeder specifications, locations.
   5. Procedures for handling emergency stops and temperature drops.
5. Discontinuous agitating water retorts
   1. RPM's timing and control.
   2. Over-pressure supply and control.
   3. Method of heating water.
   4. Come-up steps to heat to processing temp.
6. Hydrostatic retorts
   1. Type, number of chains and number of flights in steam, timing of container carrier.
   2. Where the scheduled process specifies maintenance of particular temperatures in the feed and exit water legs, location of MIG thermometers and recording devices in the water legs.
   3. Vents and bleeders, specifications and location
   4. Disposition of stray containers.
7. Cascading/spray water retorts
   1. Method of heating water (e.g. heat exchanger, direct injection of steam into water, steam distribution pipes).
   2. Come-up steps in process.
   3. Water flow, measurement, (e.g. flow meter, pressure, none) is flow the same as that during temperature distribution studies.
   4. Method used to insure water distribution system is not clogged (e.g. examination of water distribution manifold and sprays, physical cleaning, chemical cleaning).
   5. Water Pump size, inlet diameter, and horsepower.
   6. Location of water inlet into shell.
   7. Timing of RPM's on rotational models.
8. Steam-air
   1. % steam/air mixture, is it the same as that used during temperature distribution studies.
   2. Fan operation, method of checking.
   3. Timing of RPM's on rotational models

III. Processing and Production Records

1. Production Records
   1. Frequency of measurement and recording of critical factors.
   2. Evidence of critical factors not within established limits.
2. Processing Records
   1. Thermal processing records maintained as per 21 CFR 113.100.
   2. Thermal processing charts and records can be correlated.
   3. Computer generated records, if used document that all information required by 21 CFR 113 is being captured. Document manufacturer of hardware and software, report procedures for validation/maintenance of equipment

IV. Finished Product

1. Warehouse
   1. Evidence and extent of spoilage and/or abnormal containers
   2. Incubation practices
2. Complaint Files - Evidence of under-processing and/or spoilage
3. Product Recalls
   1. Nature of recall, date of recall
   2. Disposition of product
4. Process Deviations
   1. Procedures for handling
   2. Disposition is documented.

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