September 16. 2002
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Supplement to M-b-336, Bardiani ZL Mix-Proof Valve (2" inch)
This supplement to M-b-336, Bardiani ZL Mix-Proof Valve (2" inch) provides for the acceptance of larger valve sizes (2.5", 3", and 4") and the Giotto Control Top for networking capability.
In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guide for Evaluating Construction, FDA's Pacific Region Dairy Products Team (DPT) and CFSAN's Milk Safety Team have evaluated and validated the technical information submitted by the Pacific Region Dairy Equipment Review Committee (PRDERC) addressing the Bardiani ZL (2.5", 3" & 4"), Single-Bodied Double Seat Mix-Proof Valve and the Giotto Control Top for networking capability.
The Bardiani ZL Mix-Proof Valve (2", 2.5", 3" and 4") has been designed to comply with Item 15p. PROTECTION FROM CONTAMINATION, 15p.(B) of the Grade "A" Pasteurized Milk Ordinance. The valve may be used as part of a fail-safe system to separate milk and milk products from tanks or circuits containing cleaning and/or sanitizing solutions. This valve cannot be used to separate raw products (dairy, non-dairy or water) from pasteurized milk or milk products.
The technical information that was reviewed addressing the Bardiani ZL Mix-Proof Valve constitutes the PRDERC's Engineering Design and Technical Construction File (EDTCF) PR-02-06. The material in the EDTCF is the property of the manufacturer and may be shown at their discretion.
For additional information regarding this equipment, please contact:
Bardiani Valvole USA/ProTherm
4203 W. Alamos
Fresno, California 93722
Attn: Milos Cikara
Phone: (559) 271-2150
Fax: (559) 271-2151
FDA's review and acceptance of this piece of 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.
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.cfsan.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
Jonathan M. Gardner
FDA/MSB Milk Sanitation Officer