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M-b-325 : ABB Kent-Taylor C1950 Series Safety Thermal Limit Recorder (STLR) for A use on Continuous Flow Pasteurization and Aseptic Processing Systems

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HHS:PHS:FDA:CFSAN:OFP:DCP:MSB

200 C. Street SW
Washington, DC 20204

M-b-325

DATE: September 20, 1996

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: ABB Kent-Taylor C1950 Series Safety Thermal Limit Recorder (STLR) for A use on Continuous Flow Pasteurization and Aseptic Processing Systems

The ABB Kent-Taylor C1950 series STLR has been reviewed and found to comply with the provisions of the Grade A Pasteurized Milk Ordinance (PMO) applicable to Safety Thermal Limit Recorders for continuous flow pasteurization and aseptic processing systems for milk and milk products. Compliance is based upon installation and operation in conformance with manufacturer specification and including the following provisions:

  1. When installed, the STLR will comply with all test requirements outlined in the PMO Section 16p, Appendix H and Appendix I, and the applicable FDA criteria of Computers on Public Health Controls of Milk Pasteurizers, (M-I-88-11).
  2. The C1950 Series STLR is programmed using a series of command instructions stores on an EPROM chip. The chip is marked C1900-2001.
  3. Attached is COMMANDER C1950 HTST/STLR PROGRAMMING reference chart which identifies basic configuration values that will be found during verification. Items of regulatory concern are highlighted with an asterisk *. For HHST and aseptically processed products the diversion set point(s) shall be modified appropriately.
  4. Configuration values are set by the manufacturer but are operator adjustable. They shall be set and verified on installation. Configuration values identified as regulatory concerns and the EPROM chip identification shall be recorded and maintained by the operator and the regulatory agency. These will be verified as a part of required tests by the regulatory agency.
  5. After configuration values are set the internal LOCK OUT SWITCH shall be engaged (see attachment). The chart plate shall then be sealed by the regulatory agency.
  6. On multiple diversion installations, the diversion set point shall be continuously recorded on the chart.
  7. The STLR shall not contain a communications option.
  8. The temperature sensor shall be a platinum RTD fast response tip that meets the requirements of test 8, Appendix I, of the PMO. The cap of this RTD shall be sealed by the regulatory agency to prevent switching of temperature sensors.
  9. The STLR circular chart has a range of 120-2200F for standard HTST operation and a 12 hour revolution. For HHST or aseptic processing applications alternate chart ranges shall be used.
  10. The hot milk temperature recording pen is adjustable in the Operator Level under the configuration SECOdE. This will enable the operator to make minor adjustments in the recorded temperature to compare with the indicating thermometer without a need to break the regulatory seal.

Further information or copies of manufacturer operation and programming guides may be obtained by contacting:

ABB Kent-Taylor, Inc.
P.O. Box 20550
Rochester, NY 14602-0550
Phone 716-272-6250
FAX 716-273-6207
Attn: Steve Frate, US Marketing Manager

FDA's review of this equipment and our findings of compliance with applicable PMO items does not constitute agency endorsement or approval and any representation of FDA "approval" is false.

Charles D. Price
Steven T. Sims

attach:
Commander C1950 Series HTST/STLR Programming (3 pages) (9/23/96)
Commander 1950 STLR & HTST (4 pages) (February 1996)
Commander C1900/C1950 Seal/Lockout Instructions (1 page)
Introduction - C1950 Series HTST Controller (2 pages)