Cleaning Validation Protocol in a Cosmetic company

[Rlongwell83]

Hi I am new to this site and new to Industry, all industry, I worked as a validation technician for a year at a cosmetic company and my new company wants me to start validating EVERYTHING. I have always had templates before and I did a total of 5 validations the year I was at the other company, however 3 of them were process and 1 was software and 1 was equipment.

Anyway I was wondering if anyone had any template or examples for a cleaning validation protocol.

 

[Marc]

Do you have a list of everything you must validate?

 

[Rlongwell83]

I don't have a list of EVERYTHING that needs to be validated, mainly because I don't know everything that needs to be validated. The other company I was in validated EVERYTHING from Mixers to Tanks to all of their filling machines, the HVAC system, Compressed Air System, DI water system, Software System, hand held scanners. I also remember they had a cleaning validation and it was one or two binders and it just said cleaning validation. So I am assuming it was one validation for everything, but then they had a separate one for the DI system. So basically I am not sure where to begin, I figured it would be a cleaning validation for the Tanks and mixers, then go on to sanitization?

Also do you have to do a seperate cleaning validation for each Machine?

 

[achorste]

Apologies if this is a silly question - slight clarification required - Are you referring to validation of a cleaning process (i.e. a process the parts go through as part of the manufacturing route)?

 

[Rlongwell83]

Yes, sorry if I wasn't very clear, I am a bit frazzled.

So in answer to your "silly" question: Yes I am attempting to do a validation of the cleaning process, but I am not sure where to begin. The only validations I have done are process validations of an OTC product (3 to be exact), and two IQ OQ, and PQ validations of filling machines and one IQ OQ on a handheld scanner. NEVER a cleaning validation.

Any form of help would be....well helpful

 

[ScottK]

I've performed cleaning validations.
I suggest, if at all possible, you hire a 3rd party to help you develop the protocols.
When I joined a contract packager that filled food, drug, and cosmetic packages I had only done equipment validations. In order to learn cleaning validation I needed outside help...
most customers that required such validation were happy to supply protocols. All I did was buy swabs and media, follow the directions in the protocol, and send it to a lab for analysis on what the protocol called out.

The hardest part is determining what you're checking for... biologicals? Chemicals? Residuals from past runs? all of the above? I definately needed help with that and still would today. My degree is manufacturing engineering, not microbiology or chemistry.

Unfortunately I no longer have the protocols to share but I remember we had to take swabs of every piece of equipment that came into contact with the media - pots, mixers, piping, filling nozzels, re-useable hoses, pump innards, etc. And we kept a cleaning log book for every on of these.

 

[Rlongwell83]

I am at a Cosmetic company that manufactures their own products. They haven't changed anything since 1990 and they don't think they should have to change. All they know is that they need to have their OTC products validated and they think it can happen in one day. I am the only person here that even has the slightest concept on what a validation protocol actually is. So a third party might be the right move.

I mean I graduated from college 2 years ago so my experience is certainly minimal but I have a BS is Zoology (odd I know). And I am finding that since I am the youngest person here no one will listen to me, they think I am a "know it all" even though I do all the research and tell them the rules and show them where they can find it and why they have to change. grr ok I will get off my soap box.

Anyway, yes validation with a third party, thank you for the advise.

 

[Rlongwell83]

Oh and yes Here is what I know of the cleaning validation,

Everything needs to be swabed for microbial load, and everything needs to be taken apart and looked into and checked for product residue. I know we have to coordinate with manufacturing, and I know I have to describe the cleaning process and write a protocol with tables and whatnot for the test results.

 

[ScottK]

I am at a Cosmetic company that manufactures their own products. They haven't changed anything since 1990 and they don't think they should have to change. All they know is that they need to have their OTC products validated and they think it can happen in one day. I am the only person here that even has the slightest concept on what a validation protocol actually is. So a third party might be the right move.

I mean I graduated from college 2 years ago so my experience is certainly minimal but I have a BS is Zoology (odd I know). And I am finding that since I am the youngest person here no one will listen to me, they think I am a "know it all" even though I do all the research and tell them the rules and show them where they can find it and why they have to change. grr ok I will get off my soap box.

Anyway, yes validation with a third party, thank you for the advise.

The most useful thing a third party can do right now is show the management the scale of the product.

I recommend getting one in ASAP just to give a quote. An itemized quote may open managements' eyes.

 

[iansawyer]

First up, I have been in your situation before, and I don't envy your task. Life is tough at an OTC/cosmetic company, and I'm willing to bet that your budget for this project is non-existent.

To be thorough, you will need to prove that your cleaning process:
1) removes all traces of previous product
2) removes all traces of cleaning products used in the cleaning process
3) leaves you equipment microbiologically clean

This is a lot of work when you consider all the products and equipment that you manufacture/use in your facility. Here is how you can reduce the workload:

1) Start by grouping similar equipment types so that if you validate one tank with a mixer type "A", and a valve type "B", you can justify considering all tanks within that group to be in a validated state.
2) Also group your products with similar active ingredients and matrices (e.g. water-based, oil in water emulsion, water in oil emulsion, etc). After you have validated the worst case, you can justify considering the rest of that group to be in a validated state.

If you send me an email (see my profile), I can send you a couple of templates to get you started.

Good luck