M-b-358, Sup1: Supplement: Tuchenhagen Flow Diversion Device Type XKR and XWR, Equipped With Proximity Switches , Sizes 1”, 1.5”, 2.0”, 2.5”, 3.0”, 4.0” And 6.0”
Issuance Date: November 4, 2010
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Dairy and Egg Branch (HFS-316)
SUBJECT: Tuchenhagen Flow Diversion Device Type XKR and XWR, Equipped With Proximity Switches, Sizes 1”, 1.5”, 2.0”, 2.5”, 3.0”, 4.0” And 6.0”
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 Tuchenhagen Flow Diversion Device Type XKR and XWR, Equipped with Proximity Switches, Sizes 1”, 1.5”, 2.0”, 2.5”, 3.0”, 4.0” and 6.0” and have validated and confirmed the technical information submitted by Tuchenhagen Flow Components, LLC.
The Tuchenhagen Flow Diversion Device consists of two (2) Tuchenhagen non-slamming compression-type divert valves (Type XKR and XWR) welded together to form an assembly. The assembly is used to enable the “Divert Flow”, “Leak Detect” or “Forward Flow” positions. The Tuchenhagen Flow Diversion devices are available with either vertical down (Type XKR) or horizontal (Type XWR) divert ports to suit the installation requirements. M-b-358 (Supplement 1) addresses the use of control top Module T.VIS® M-1 FDD with a proximity switch as the position detection device instead of a micro-switch as reviewed and referenced in M-b-358.
When constructed, installed, operated and maintained as described in this memorandum, the Tuchenhagen Flow Diversion Device Type XKR and XWR, Equipped with Proximity Switches, Sizes 1”, 1.5”, 2.0”, 2.5”, 3.0”, 4.0” and 6.0” has been found to meet the applicable provisions of Item 16p-Pasteurization and Aseptic Processing of the Grade “A” Pasteurized Milk Ordinance (PMO). Compliance with the PMO is based upon construction, installation, operation and maintenance as described in the Manufacturer’s Operating Instruction Manual, Issue 2010-03/Revision 13, and the Operating Instructions for Control Module T.VIS® M-1 FDD, Issue 2010-03, as well as the following provisions:
- The installation shall comply with applicable tests in Appendix I of the PMO.
- Appendix I, Test 5.4, Device Assembly, shall be conducted in accordance with the testing procedures outlined in the installation and operation manual provided by the manufacturer. The manufacturer shall provide a gap gauge to facilitate conducting this Test in the required manner.
For information regarding this equipment, and to request copies of the documents listed, please contact:
90 Evergreen Drive
Portland, ME 04103
Attn: Mr. Dave Harding
Telephone: (207) 797-9500
FDA’s review and acceptance of this flow diversion device does not constitute FDA or State Regulatory Agency 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 CFSAN 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 CFSAN Web Site, please e-mail your request to Robert.Hennes@ fda.hhs.gov.
FDA Regional Dairy Specialist
CAPT Robert Hennes, RS, MPH
MST Senior Milk Sanitation Officer
Cover Page-Manufacturer’s Operating Instruction Manual, Flow
Diversion Device with Proximity Switch, Issue 2010-03/Revision 13,
Part no. 430-455
Cover Page-Operating Instructions, Control Module T.VIS® M-1
FDD, Issue 2010-03, Part no. 430-539
Flow Diversion Device with Proximity Switch
Figure 1: XKR & XWR
Issue 2010-03 / Revision 13
Part no. 430-455
Control Module T.VIS® M-1 FDD
Made by GEA Tuchenhagen
Part no. 430-539
GEA Mechanical Equipment