Milk Safety References
National Conference on Interstate Milk Shipments (NCIMS)

Tetra Pak Aseptic Product Valve (APV) (Commonly Known as the ABC Valve) Used to Separate Cleaning Solutions from Pasteurized and/or Aseptic Milk and Milk Products (M-b-349)

 

TO:	All Regional Food and Drug Directors Attn: Regional Milk Specialists
FROM:	Milk Safety Branch (HFS-626)
SUBJECT:	Tetra Pak Aseptic Product Valve (APV) (Commonly Known as the ABC Valve) Used to Separate Cleaning Solutions from Pasteurized and/or Aseptic Milk and Milk Products

When constructed, installed and operated as described in this memorandum, the Tetra Pak Aseptic Product Valve (APV) (commonly known as the ABC valve) has been found to comply with Section 7, Item 15pB 1.C. of the Grade "A" Pasteurized Milk Ordinance (PMO) for separating cleaning solutions from pasteurized and/or aseptic milk and milk products on Tetra Pak and Tetra Rex packaging machines.

The valve consists of three valve actuators and seats that control the flow of product, steam and cleaning solutions through a common area. This valve has been used for many years at the product inlet piping of Tetra Pak and Tetra Rex packaging machines. The steam trace exits at the top of this valve, contrary to the requirements of Section 7, Item 15pB 1.C.1 of the PMO. (Refer to the attached diagram.)

If the attached SOP titled "Intermediate Cleaning Standard Operating Procedure--Tetra Pak Aseptic Product Valve (APV)", dated April 20, 2005, is complied with, FDA finds this valve to be in compliance with Section 7, Item 15pB 1.C of the PMO.

Also attached is an example of a mechanical cleaning chart indicating a normal intermediate wash and an intermediate wash in which a steam barrier alarm has occurred. If an intermediate wash is observed to contain a steam barrier alarm, plant records shall be reviewed to assure that the "Intermediate Cleaning Standard Operating Procedure--Tetra Pak Aseptic Product Valve (APV)", dated April 20, 2005, was followed.

For additional information regarding this piece of equipment please contact:

Brian Thane
Director - Aseptic Technology
Tetra Pak Inc.
Packaging Systems
3300 Airport Road, Bldg. 900-A
Denton, Texas 76207 USA
Tel: (940) 565-8910
Fax: (940) 565-8931

FDA's review and acceptance of this piece of equipment does not constitute FDA 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 .

/ss/

Stephen T. Sims
Milk Sanitation Officer FDA/MST

Attachments:

• Diagram of ABC Valve (In the intermediate cleaning position)
• The Tetra Pak "Intermediate Cleaning Standard Operating Procedure --- Tetra Pak Aseptic Product Valve (APV) ", dated April 20, 2005
• Example of a mechanical cleaning chart (Showing the difference between a normal intermediate wash and an intermediate wash containing a steam barrier alarm.)

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April 20, 2005

Intermediate Cleaning Standard Operating Procedure
Tetra Pak Aseptic Product Valve (APV)

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1. Prior to the start of an Intermediate CIP the Operator will physically inspect the product pipe-work for leaks in the Tetra Pak Aseptic Product Valve (APV) cluster with the steam enabled and before connecting the intermediate CIP piping.
2. If there is no steam leak, the operator will record the observation in the filler log or other appropriate document that the C-valve was intact. The CIP preparation can continue and the intermediate CIP cycle started.
3. If a condensate leak is detected, the operator will stop CIP preparation and take the filler off-line until maintenance repairs the problems.
4. If during an Immediate CIP cycle, the steam barrier temperature alarm is activated, the cleaning sequence will be disengaged and cannot be restarted until the integrity of the APV cluster is verified. The verification of the integrity of the APV valve is necessary only if the filler is in series with other operational fillers. When an Intermediate CIP steam barrier alarm occurs on the ABC valve during the production of shelf-stable, commercially sterilized products, the alarm event is treated as a Process Deviation with a Process Authority.
   
   In the case of refrigerated products, the following points (5-10) shall apply:
5. The Operator will physically inspect the product pipe-work for the presence of steam escaping from the C-valve when the steam is enabled.
6. If there is no steam leak, the operator will record the observation in the filler log or other appropriate document that the C-valve was intact and recorded on the CIP chart the reason for the short or incomplete intermediate CIP cycle. The intermediate CIP cycle can be restarted.
7. If there is a stream leak at the C-valve, the operator will discontinue use of the filler and confirm the A-valve seat integrity. To check the integrity of the A-valve seat, first disable the steam flow to the steam chamber. After the steam flow is stopped, open the C-valve seat and inspect the area for the presence of product.
8. If there is no product leak, the operator will record the observation in the filler log or other appropriate document that the C-valve was intact and record on the CIP chart the reason for the short or incomplete intermediate CIP cycle. The intermediate CIP cycle cannot be restarted until the C-valve has been repaired.
9. Following the repair of the C-valve, the operator will physically inspect the product pipe-work for the presence of steam escaping from the C-valve when the steam is enabled. If there is no steam leak, the operator will record the observation in the filler log or other appropriate document that the C-valve was intact and the CIP cycle can be restarted.
10. When a product leak is detected at the A-valve, the operator discontinues use of the filler, and the entire production produced on downstream fillers, 5 minutes before the time the intermediate CIP started until 5 minutes after the cycle was terminated, is segregated for final disposition.

Tetra Pak Inc.
3300 Airport Road, Building 900-A, Denton Texas 76207 U.S.A.
Telephone: 940-565-8800 Telefax: 940-565-8931