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M-b-332: Anderson AV9900 Microprossor Based Safety Thermal Limit Recorder (STLR)

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HHS:PHS:FDA:CFSAN:OFP:DCP:MST

200 C. Street SW
Washington, DC 20204

M-b-332

DATE: August 16, 1999

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

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Anderson AV9900 Microprossor Based Safety Thermal Limit Recorder (STLR)

The Anderson AV9900 HTST Recorder Controller has been reviewed and found to comply with the applicable provisions of the Grade A Pasteurized Milk Ordinance (PMO) when used as a safety thermal limit recorder ONLY for continuous flow pasteurization and aseptic processing systems.

Compliance with the PMO is based upon installation and operat ion in conformance with manufacturers specifications and includes the following criteria:

  1. When installed the controller will comply with all applicable controls and test requirements outlined in PMO section 16p, Appendix H and Appendix I and specific procedures regarding the completion of PMO Appendix I tests detailed in Parts 3.0 and 4.0 of AV9900, Doc 1029, Rev. 2.0.

  2. The AV9900 is programmed using commands on two EEPROM chips identified U7 and U8.

  3. To program and/or confirm configuration values for the AV9900 a security shunt, located behind a chart plate must be positioned in the program mode. This will place the FDV in the divert position even if hot product rises above the set point.

  4. Configuration values are to be validated as outlined in the Anderson Instruction Manual AV9900 Field Setup Rev. 2.0 Doc.1029 using scroll arrow keys. The default parameters as detailed in sections 5.0 (5.1, 5.2, 5.3) must be set as specified to meet PMO requirements. These items shall not be accessible in the RUN mode.

    Key public health items are:

    STLR Function Set-Up

    5.1 Parameter 1:STLR shall be set as NORMAL, the system MUST NOT include simulated run mode.
    5.1 Parameter 3:RED (hold tube temp)
    5.1 Parameter 6:Shall have default parameter but is also accessible in RUN mode.
    5.1 Parameter 7:As set
    5.1 Parameter 8:Diversion set point recorder

    Recording Pen Set-Up

    5.2 Parameter 3: Starts scale on inside of chart
    5.2 Parameter 4: Ends scale at outside of chart
    5.2 Parameter 5: Start of scale on chart
    5.2 Parameter 6: End of scale on chart
    5.2 Parameter 7: Scale divisions
    5.2 Parameter 8: Season (Probe) default – automatic
    5.2 Parameter 9: Divert of FDV
    5.2 Parameter 10: Record set point
    5.2 Parameter 12-17: Same as 3-8 for second recording pen (i.e. cold milk temperature , etc.)

    Chart Set-Up

    5.3 Parameter 2: 12 hour chart
    5.3 Parameter 3 1 hour Major Scale Division
    5.3 Parameter 4: 4-15 Minute Chart Divisions
    5.3 Parameter 5: Allows major printing without printing scale information (overlap)
    5.3 Parameter 11: Default at NONE. Allows temperature trace without scale print on + 12 hour overlap.

  5. On installation the Configuration values for cut in/out temperature(s), chart parameters, recording pen colors, event pen parameters and other critical factors, along with chip identification shall be recorded for plant and regulatory files.

  6. After testing the software configuration, the Security Shunt shall be placed in the run mode, the chart cover plate positioned and a regulatory seal attached through the drilled cover bolts.

  7. The AV9900 prints the temperature pen and event pen traces every 12 seconds in red ink. Temperature at the hold tube is monitored twice each second and the FDV position is monitored once each second. Public health controls are in place continuously and chart tracing accurately reflect these controls. Sampling rate, data storage and printing rate are factory programmed and cannot be reprogrammed in the field.

  8. The temperature value and the event marker traces are pre-printed on circular charts which are pre printed with a set of concentric lines space at .04 inches apart. The temperature range is programmed with the configuration values at a range of 120 degrees F to 220 degrees F in one degree F divisions and a time span of 12 hours in 15 minutes divisions.

  9. The AV9900 can be programmed for multiple diversion points. The diversion set point must be recorded and is factory set using the green pen.

  10. Other traces, such as cold milk temperature, may be printed on the chart, only if they are scaled to maintain clarity of the pasteurization temperature trace.

  11. Time, date and chart label are printed on the outside perimeter of the chart. On changing charts the AV9900 will print a starting reference line at the beginning of an hour. Hold tube temperature trace will begin at true current time. It may take 3-5 minutes to print a new chart header. During this time all public health controls are monitored. All required chart data will be printed.

  12. The hold tube temperature sensor (RTD) is a sanitary dual element. The stainless steel conduit housing shall be sealed by the regulatory agency. Probe/sensor default results in automatic diversion of the Flow Diversion Device.

  13. The AV9900 shall not contain a communications option.

  14. Do not perform indicator/recorder thermometer check or cut in/cut out check while unit is in the accelerated print mode. The recording pen will pause at the outer edge of the chart between passes in real time and be in continuous motion while accelerated.

  15. The "hold" button will stop the recording pen to enable chart changes or manual entry by the operator. The "continue" button will restart the recording pen. All public health controls are in place during the "hold" period and the accelerated printing will update the chart when continued.</ P>

    Run mode parameters accessible to the user are detailed in Section 6.0 (6.1, 6.2, 6.3) of Doc 1029, Rev. 2.0. In 6.3, Operation Model RUN Key: Scroll under function Key STLR is provision that allows the operator to adjust the hot milk recording pen to agree with the reference thermometer without breaking the seal.

  16. LED lights are programmed to real time.

  17. While conducting PMO test 8, thermometric response, the STLR may default and indicate probe or sensor failure at the time the probe is placed in the hot solution bath. This is due to slight variances in the dual sensing elements. This, in itself, is not indicative of equipment malfunction. This occurrence is corrected by immediately pressing the DISPLAY key which will reset the controls and allow for completion of the test reading. If significant variance in the probes has occurred, the control will not reset and repairs are indicated. See test 4.4 in Doc 1029, Rev. 2.0 for additional test 8 criteria.

For further information, including a copy of the AV9900 Field setup Instruction manual, contact:

Anderson Instruments
150 Auriesville Road
Fultonville, NY 12072
Attn: Bill Wilson
Phone: (518)922-5315 ext 228
FAX: (518)922-8997

FDA's review of this equipment and our finding of compliance does not constitute agency endorsement or approval. Any representation on a label or in any printed literature as "FDA Approved" is false.

Charles D. Price
Steven T. Sims

Attach: AV9900 Brochure, October, 1997 AV9900 Field Set up Instruction Manual, Rev. 2.1 Doc.1029