Automate CIP, track pipe status

Oh how much easier the manufacturing of pharmaceuticals, nutritional, and beverage products would be if the vessels, equipment, and pipes used in processing the product could be disassembled, dropped in a sink, vigorously scrubbed and then run through a sterilizer to remove contaminants. In reality it's impractical to use cleaning techniques commonly found in laboratories and kitchens in ...

12/01/2000


Oh how much easier the manufacturing of pharmaceuticals, nutritional, and beverage products would be if the vessels, equipment, and pipes used in processing the product could be disassembled, dropped in a sink, vigorously scrubbed and then run through a sterilizer to remove contaminants. In reality it's impractical to use cleaning techniques commonly found in laboratories and kitchens in large-scale production facilities. Vessels, equipment, and pipes must be cleaned where installed. The clean in place (CIP) process ensures that piping, vessels, and equipment are free of inorganic and organic contaminants. For processes where microbiological cleanliness is essential, CIP also encompasses steam in place (SIP) procedures.

Many production facilities do CIP manually, but history repeatedly indicates manual cleaning can be unsafe and the level of cleaning is typically much less effective and less consistent than fully automated CIP procedures provide. But what's eye opening to first timers is that automating CIP procedures is often more complex and requires greater efforts in design, testing, and validation than for automating "real" products.

How hard can it be?

For those who have never automated a CIP process, it seems simple and straightforward. After a vessel is drained of a product, all that's required is to rinse, clean, wash, and do a final rinse—how hard is that?

Not too hard if all that were required was to ensure cleaning and washing mixtures were correctly formulated and proper flows, temperatures, and pressures were maintained for one product or product family. But production facilities designed and hard-piped to produce a single product or family of products, are giving way to flexible facilities capable of producing multiple products and maximizing the use of vessels and equipment.

Key to achieving near maximum flexibility and asset utilization is the ability to move contents of one vessel to any other vessel with minimum effort. This requires replacing "hard-piping" with any one of several flexible transfer-piping methods, adding to the complexity of CIP automation. For example, vessel, transfer piping, and equipment path integrity must be maintained until cleaned, and each piece of equipment must be individually tracked for dirty , cleaning, clean, and cleaned but expired status.

Cleaned but expired?

Given time, some contaminants can reappear, so a vessel, pipe segment, or piece of equipment may require recleaning before being used to produce a product, thus the need for the cleaned but expired status.

In developing a product's control logic, it's important to "acquire" each piece of equipment as a prerequisite for introducing material. Usually vessels and pipe segments are exclusive use; meaning only one operational sequence can acquire the element at a time. Equipment, such as transfer pumps, are often available for shared use, meaning they can be acquired and used by more than one operational sequence as long as the materials passing through the shared resource are compatible.

When evaluating the next control system, be sure to investigate the system's ability to handle CIP (See sidebar). In the long run, it may be less effort to automate CIP than to ensure manual CIP activities provide contamination-free vessels, equipment, and piping segments.


Author Information
Dave Harrold, senior editor, dharrold@cahners.com


What to look for in a CIP 'aware' control system

Automating CIP procedures requires the control system provide capabilities to ensure:

Each piece of equipment, vessel, and piping segment can include dirty, cleaning, clean, and cleaned but expired status;

Each piece of equipment, vessel, and piping segment can include a reinforced resource counter that is decremented when the item is acquired and incremented when the item is released;

Each piece of equipment designated as a shared resource can include a placeholder that contains the product code of the first operational sequence to acquire it and prevent itself from being acquired by operational sequences with incompatible product codes;

Collections of equipment, vessels, and piping segments used to transfer a product, use reinforced path integrity monitoring and alarming until CIP is completed and each item's status is set to clean;

CIP units can ensure media solution flows, temperatures, and pressures are maintained for the designated time periods. Frequently this is accomplished using a resource counter that limits the number of transfer paths that can be cleaned at one time; and

CIP units can ensure the integrity of all wash and sanitizing media solutions.


Author Information
Dave Harrold, senior editor,dharrold@cahners.com


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