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M-b-368: GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System and Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster

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HHS:PHS:FDA:CFSAN:OFS:DPDFS:DEB:MST

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-b-368

November 13, 2012

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

FROM: Dairy and Egg Branch/Milk Safety Team (HFS-316)

SUBJECT: GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System and Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster

The GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System and Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster functions as an unconventional single bodied mix proof valve used to separation teat dipping/backflush system chemicals and raw milk. These GEA Farm Technologies Milk Safety Valves are designed for usage only with conventional milking systems and are not acceptable for use with Automatic Milking Installation (AMI) systems due to this unconventional single bodied mix proof valve having a visual leak detection rather than an instrumented leak detection system required for AMI systems.

In accordance with M-I-00-2, Milk and Milk Product Equipment – A Guideline for Evaluating Construction, FDA's Central Region Milk Specialists and CFSAN's Dairy and Egg Branch/Milk Safety Team have specifically evaluated the GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System and Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster, and have validated and confirmed the technical information submitted by GEA Farm Technologies and the review findings of the Atlantic/Midwest Region Dairy Equipment Review Committee (AMDERC).

When the GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System and Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster are installed, operated and maintained in accordance with and as described in the Apollo™MilkSystem Automatic Teat Dipping and Backflush System Instruction Manual number 7750-9015-088, dated April 27, 2012, Section 5.5.1, page 50 and Section 9.4.12, page 207, for usage only with conventional milking systems and are not acceptable for use with Automatic Milking Installation (AMI) systems, have been found to meet the applicable provisions of Item 9r-Utensils and Equipment - Construction and Item 14r-Protection From Contamination of the Grade "A" Pasteurized Milk Ordinance (PMO).

The technical information that was submitted and reviewed addressing the GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System and Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster constitutes AMDERC's Engineering Design and Technical Construction File (EDTCF). The material in the EDTCF is the property of the manufacturer and may be provided at their discretion.

For additional information regarding this equipment and to request a copy of the documents listed, please contact:

Mr. Bob Buck
Product Manager − Sanitation and Vacuum Equipment
GEA Farm Technologies, Incorporated
20903 West Gale Avenue
Galesville, Wisconsin 54630-6659
Phone: 1-608-582-2221 ext 3512
Fax: 1-608-582-3165
Mobile: 1-630-240-5826
bob.buck@gea.com
www.gea.com disclaimer icon  | www.gea-farmtechnologies.us disclaimer icon 

FDA's review and acceptance of the GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System and Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster 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" would be considered as 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.
 

/s/

Donald R. Goldsmith
FDA Regional Dairy Specialist
 

/s/

CAPT Robert Hennes
FDA/MST Milk Sanitation Officer

Attachments:

Picture of the GEA Farm Technologies Milk Safety Valve #7750-0121-961 as Part of the Apollo™MilkSystem Automatic Teat Dipping and Backflush System
Picture of the GEA Farm Technologies Milk Safety Valve #7025-2620-040 as Part of the GEA IQ Milking Claw Cluster
Apollo™MilkSystem Automatic Teat Dipping and Backflush System Instruction Manual Number 7750-9015-088, dated April 27, 2012 and back flush manual number 7750-9015-088 dated April 27, 2012 cover page

 GEA Farm Technologies Milk Safety Valve #7025-2620-040

GEA Farm Technologies Milk Safety Valve #7025-2620-040 as part of the GEA IQ Milking Claw Cluster
 

 GEA Farm Technologies Milk Safety Valve 7750-0121-961

GEA Farm Technologies Milk Safety Valve 7750-0121-961
 

Cow automatic teat dipping
 

GEA Farm Technologies

ApolloMilkSystem

Automatic teat dipping and backflush system

Instruction Manual / Installation Instructions / Parts List (Original instructions)

7750-9015-08827Apr-2012