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					Steven T. Sims
FDA Regional Dairy Specialist			FDA/MST Milk Sanitation Officer
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Attachments:
Pictures of Coupling Sleeve (Model 2250)
   LTI, Inc., Coupling Sleeve (Model 2250)-Table of Contents-EDTCF (PR-00-01)

 
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"
 
 
 
 
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M-b-333	1	November 16, 2001