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M-b-324: ABB Kent-Taylor C1900 Series Magnetic Flow Meter Recorder/Controller

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

200 C. Street SW
Washington, DC

M-b-324

DATE: September 19, 1996

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

FROM: Milk Safety Branch (HFS-626)

SUBJECT: ABB Kent-Taylor C1900 Series Magnetic Flow Meter Recorder/Controller

The C1900 series circular chart recorder/controller for magnetic flowmeter systems has been reviewed and found to comply with the applicable provisions of the Grade A Pasteurized Milk Ordinance (PMO) for continuous flow pasteurization and aseptic processing systems for milk and milk products. Compliance is based upon installation and operation in conformance with manufacturer specifications and the following provisions:

  1. This recorder/controller shall be installed in a system that complies with the criteria for COMPONENTS and PLACEMENT of COMPONENTS as detailed in PMO Appendix H, Magnetic Flow Meter Based Timing Systems for HTST Pasteurizers.
  2. The commander C1900 series program is stored on an EPROM chip. The chip is marked C1900-2001.
  3. The chart shall have a recording range of 0 - 100 or other zero based flow range and a chart speed of one revolution per 12 hours. Chart 5001225-3 complies with these criteria.
  4. Configuration values are set by the manufacturer but are operator adjustable. Attached are the Commander 1900 Series Programming Guide Set-up & Configuration (2 pages) which identify basic configuration values that will be found during verification. Items of regulatory concern are identified with an asterisk *.
  5. Configuration values identified as regulatory concerns along with the EPROM chip identification shall be recorded at verification and copies maintained by the operator and the regulatory agency. These values will be verified as a part of required tests by the regulatory agency.
  6. 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.
  7. The recorder shall have one pen to record actual flow rate and one event pen to indicate the position of the flow alarm with respect to flow rate.
  8. The high flow set point shall be at a level that can be verified by the operator or regulatory agency without breaking the regulatory seal.
  9. A sanitary magnetic flow meter shall be used which has been reviewed by USPHS/FDA or one that is equally accurate and reliable.
  10. When installed the system shall comply with all test requirements (2A-2F) of test 11, Magnetic Flow Meter Systems of Appendix I, PMO.
  11. When installed the systems shall comply with all applicable PMO requirements including criteria for use of Computers on Public Health Controls of Milk Pasteurizers (M-I-88-11).
  12. The flow rate recorder shall not contain a communications option.

Further information or copies of the material for this equipment 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:
Configuration Values Page 5 & Page 6, R. Howell (9/23/96)
Commander C1900/C1950 Seal/Lockout, (1 page)
ABB Kent-Taylor MBTS Brochure, (2 pages)