4.11.6 Cleaning in Place, Need Help with Format for Validation?
Started by FS consultant, Aug 30 2012 02:31 PM
Hi,
can anyone help me with the validation to be done for CIP? Any format for the same?
Rgds
Poulami
can anyone help me with the validation to be done for CIP? Any format for the same?
Rgds
Poulami
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Dear Poulami,Hi,
can anyone help me with the validation to be done for CIP? Any format for the same?
Rgds
Poulami
Not sure whether you mean verification? Validation is typically providing specific evidence that your proposed system (???) can be expected to work when implemented, eg via documented references ormaybe your own pilot study. if the latter it becomes more like a mini-verification IMO but equally acceptable auditorially if properly done.
Link below (there are others searchable also) gives some formatting ideas, eg if you replace the "manual setup" in post #1 by your CIP system / CIP-SOP
http://www.ifsqn.com...dpost__p__50554
Rgds / Charles.C
Dear Poulami,
CIP would involve automatic cleaning with chemicals of known concentration, specified time and flow rate(turbulence) and temperatures. Thus to ascertain whether a given CIP regime works well, then you need to carry out the process and make a follow up by taking microbial swabs(surfaces) or rinse water.
Similarly, visual inspection of the cleaned equipment should be done. This whole exercise should be documented.
The micro results should be indicative of the efficiency of the regime applied.
I hope this suffices.
Agwanda.
CIP would involve automatic cleaning with chemicals of known concentration, specified time and flow rate(turbulence) and temperatures. Thus to ascertain whether a given CIP regime works well, then you need to carry out the process and make a follow up by taking microbial swabs(surfaces) or rinse water.
Similarly, visual inspection of the cleaned equipment should be done. This whole exercise should be documented.
The micro results should be indicative of the efficiency of the regime applied.
I hope this suffices.
Agwanda.
Thanks for the info. That was helpful.
Rgds
Poulami
Rgds
Poulami
When it comes to Validation of any program or system in a food safety system I always try to start with a very simple question to myself....what is the system intended to do? I know this sounds obvious but the answer will inform you what validation should be conducted.
In terms of CIP the simple answer is to 'Clean'. From here we ask 'Clean what and why?'
Are we cleaning to control a specific pathogen, to remove residual food colours, odours, flavours or remove specific allergens prior to producing another product. In other words you need to define the specific intended purpose of the CIP system and only then can you fully validate it.
For example:
1. Which microorganisms are to be targeted? E. Coli, Salmonnella, yeasts and moulds etc? This will drive the temp, time, chemical concentration specifcation
2. Which allergens need to be controlled? RA should be conducted.
3. Any other physical or chemical demands to be meet by the CIP system. For example I am familiar with one beverage operation producing a basic favoured soft drink. The CIP system worked perfectly...no problems. They then decided to produce a juice product with real fruit 'bits'. These bits adhered to the enclosed pipework, tanks, equipment and the same CIP system proved totally inadequate. Also consider the need to remove residual cleaning chemicals.
Next set up validation program. This may involve micro testing of product, rinse waters, and internal surfaces. Make sure you swab sufficient surfaces throughout the plant and this may require dismantling pipework etc.Confirm your target pathogens are being addressed and counts are acceptable.
Validate the system for allergens. This will include validating the procedure for cleaniing, CIP and parameter followed by protein or specific allergen testing if required.
The validation exercise may tell you you need to change or redesign the process. For example temp, time and chemcial conc specifications, the nature of flow (laminar or turbulent) redesign of plant and removal of 'dead legs', effectiveness of spray balls, frequency, chemcials used, product change over plan and so on.
Also the BRC in Issue 6 introduced new specific requirements for CIP. You should take a look at these.
George
In terms of CIP the simple answer is to 'Clean'. From here we ask 'Clean what and why?'
Are we cleaning to control a specific pathogen, to remove residual food colours, odours, flavours or remove specific allergens prior to producing another product. In other words you need to define the specific intended purpose of the CIP system and only then can you fully validate it.
For example:
1. Which microorganisms are to be targeted? E. Coli, Salmonnella, yeasts and moulds etc? This will drive the temp, time, chemical concentration specifcation
2. Which allergens need to be controlled? RA should be conducted.
3. Any other physical or chemical demands to be meet by the CIP system. For example I am familiar with one beverage operation producing a basic favoured soft drink. The CIP system worked perfectly...no problems. They then decided to produce a juice product with real fruit 'bits'. These bits adhered to the enclosed pipework, tanks, equipment and the same CIP system proved totally inadequate. Also consider the need to remove residual cleaning chemicals.
Next set up validation program. This may involve micro testing of product, rinse waters, and internal surfaces. Make sure you swab sufficient surfaces throughout the plant and this may require dismantling pipework etc.Confirm your target pathogens are being addressed and counts are acceptable.
Validate the system for allergens. This will include validating the procedure for cleaniing, CIP and parameter followed by protein or specific allergen testing if required.
The validation exercise may tell you you need to change or redesign the process. For example temp, time and chemcial conc specifications, the nature of flow (laminar or turbulent) redesign of plant and removal of 'dead legs', effectiveness of spray balls, frequency, chemcials used, product change over plan and so on.
Also the BRC in Issue 6 introduced new specific requirements for CIP. You should take a look at these.
George
5 Thanks
Hi poulami
How you are doing? Did u got assistance or not?
Thanks
Gorti
How you are doing? Did u got assistance or not?
Thanks
Gorti
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