U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

M-b-325 - ABB Kent-Taylor C1950 Series Safety
Thermal Limit Recorder (STLR) for use on Continuous Flow
Pasteurization and Aseptic Processing Systems
      HHS:PHS:FDA:CFSAN:OFP:DCP:MSB
 
                                           200 C. Street SW
                                           Washington, DC  20204
                                           M-b-325
 
DATE: September 20, 1996
 
REPLY TO
ATTN OF:Milk Safety Branch, HFS-626
 
SUBJECT:ABB Kent-Taylor C1950 Series Safety
      Thermal Limit Recorder (STLR) for
      use on Continuous Flow Pasteurization
      and Aseptic Processing Systems
 
TO:   All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
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)
 
                                     M-b-325 September 20, 1996