Issuance Date: 6/29/2009
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Dairy and Egg Branch/Milk Safety Team (HFS-316)
SUBJECT: Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 (1”, 1½”, 2”, 2½”, 3”, 4” and 6”) With A Vent Cleaning Option
In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guideline for Evaluating Construction, FDA’s Pacific/Southwest Region Milk Specialists and CFSAN’s Dairy and Egg Branch/Milk Safety Team have specifically evaluated the valve vent cavity cleaning function of the Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 (1”, 1½ ”, 2”, 2½”, 3”, 4” and 6”) and validated the technical information reviewed and submitted by the Pacific/Southwest Regions Dairy Equipment Review Committee (PSRDERC).
The design of the Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 (1”, 1½”, 2”, 2½”, 3”, 4’ and 6”) provides the capability for the cleaning of the valve vent cavity and one (1) valve seat via seat lifting under normal operating conditions of 0.1 bar (1.45 psig) through ten (10) bar (145 psig), while milk or milk products are present in the opposite valve housing. In addition, the design of the Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 (1”, 1½”, 2”, 2½”, 3”, 4’’ and 6”) valve prevents impingement of liquids on the opposite valve seat gasket during seat lifting and provides for the pressure in the critical seat area of the valve vent cavity to be atmospheric or less at all times.
When constructed, installed and operated as described in this memorandum, the Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 (1”, 1½”, 2”, 2½”, 3”, 4” and 6”) With A Vent Cleaning Option has been found to meet the applicable provisions of the Grade “A” Pasteurized Milk Ordinance (PMO). Compliance with the PMO is based upon construction, installation and operation as described in the Manufacturer’s Operating Instruction Manual Issue 2009-03/ Revision 8, as well as the following provisions:
- All PMO installations must comply with the Manufacturer’s Operating Instruction Manual Issue 2009-03/Revision 8.
- The Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 shall be installed in compliance with Item 15p. Protection from Contamination, Administrative Procedures 15p.(B) of the PMO, as applicable, when the valve vent cavity cleaning option is utilized. During a seat-lift operation, the position of the seat opposite to the seat being lifted shall be monitored by a proximity switch that is interlocked with the cleaning pump or source of the Clean-in-Place (CIP) cleaning solution pressure such that if this opposite seat is determined to be other than fully closed, the cleaning pump or source of CIP cleaning solution pressure will be immediately de-energized.
- When installed, the Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 with the Vent Cavity Cleaning Option shall have an Automated Fail-Safe Control System and the Control System shall comply with applicable provisions of Appendix H. Pasteurization Equipment and Procedures, Section V. Criteria for the Evaluation of Computerized Systems for Grade “A” Public Health Controls of the PMO.
- Care must be taken to assure that the valve housing, the piping system and the leakage outlet system can drain properly.
The technical information concerning the Tuchenhagen 24/7 PMO Mixproof Tank Valve Varivent® Type MT/T_R 08 (1”, 1½”, 2”, 2½”, 3”, 4” and 6”) With A Vent Cleaning Option constitutes the PSRDERC’s Engineering Design and Technical Construction File (EDTCF) PR-08-01. The Table of Contents for this file is attached and is also on file with the PSRDERC. The material in the EDTCF is the property of the manufacturer and may be shown at their discretion.
For information regarding this equipment, and to request copies of the documents listed, please contact:
GEA Tuchenhagen US, LLC.
90 Evergreen Drive
Portland, ME 04103
Attn: Dave Harding
FDA’s review and acceptance of the option for the cleaning of the valve vent cavity for this piece of equipment does not constitute FDA endorsement or approval. Any representation on a label or in printed literature citing or indicating as “FDA Approved” is false and misleading.
An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies and State Milk Sanitation Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web Site at http://www.fda.gov at a later date.
If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.
FDA Regional Dairy Specialist
CAPT Robert F. Hennes
FDA/DEB Milk Sanitation Officer
Table of Contents
Photos of the Vertical and Horizontal Valve Mounting
TABLE OF CONTENTS
- 24/7 PMO Tank Valve - PRDERC Submission Form
- 2.24/7 PMO Tank Valve – Overall Drawing
- 24/7 PMO Tank Valve - Operations Manual
- 24/7 PMO Tank Valve - Control Module Operations Manual
- 24/7 PMO Tank Valve - Detailed Component Drawings
- 24/7 PMO Tank Valve – Laboratory Reports
- 3-A Symbol Authorization
- Manufacturing Quality Management Standards
- Independent Third-Party Test Documentation