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M-b-333: Coupling Sleeve (Model 2250)

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

200 C Street, SW
Washington DC 20204

M-b-333

November 16, 2001

TO: All Regional Food and Drug Directors

Attn: Regional Milk Specialists

FROM: Milk Safety Team (HFS-626)

SUBJECT: Coupling Sleeve (Model 2250)

In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guide for Evaluating Construction, the Pacific Region Dairy Equipment Review Committee (PRDERC), composed of State Rating and Regulatory Officials, has evaluated this Coupling Sleeve (Model 2250). FDA's Pacific Region Dairy Products Team (DPT) has validated and confirmed the technical information submitted. When constructed as described in this memorandum, this equipment 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 in conformance with the following criteria:

Coupling Sleeve (Model 2250), is intended for use as a seal of the transition point between the external surface of the Titan (SP-330) hose and the internal surface of the Sani-Seal coupling assembly (see attached diagrams).

Note: It is recommended that a thin film of food grade silicon sealant or similar material be applied between the external surface of the Titan (SP-330) hose and the internal surface of the coupling sleeve.

The technical information that was reviewed addressing the Coupling Sleeve (Model 2250) constitutes the PRDERC's Engineering Design and Technical Construction File (EDTCF) PR-00-01. The table of contents for this file is attached and is also on file with the PRDERC.

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:

LTI, Inc.
12009 N.E. 99th St.,
Suite 1402
Vancouver, WA 98682
Attn: Brad Williamson
Phone: (360) 256-2577
Fax: (360) 256-4068

FDA's review and acceptance of this equipment does not constitute agency endorsement or approval. Any representation on a label or in printed literature citing or indicating as, "FDA Approved" is false and misleading.

Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies and State Milk Sanitation Rating Officers in your region. This memorandum will also be available on the FDA Web site at http://www.cfsan.fda.gov at a later date and should be widely distributed to representatives of the dairy industry and other interested parties.

Randy Elsberry
FDA Regional Dairy Specialist Officer

Steven T. Sims
FDA/MST Milk Sanitation

Attachments:
Pictures of Coupling Sleeve (Model 2250) LTI, Inc., Coupling Sleeve (Model 2250)-Table of Contents-EDTCF (PR-00-01)

Pictures of Coupling Sleeve (Model 2250)

LTI, Inc.
Coupling Sleeve

Model 2250 Coupling Sleeve

Engineering Design and Technical Construction File (EDTCF)

Table of Contents

  • PRERC Dairy Equipment Submission Form
  • Cover Letter
  • Photos, "Coupling Sleeve Components"
  • Photos, "Coupling Sleeve Assembly Instructions"
  • Photos, "Coupling Sleeve Assembly Instructions, continued"
  • Photos, "Complete Coupling Assembly Example"
  • 3A Certificates, "Hose Assemblies"