Design for Sterilization Companies - The design of sterilization validation programs

  • Thread starter E. Madsen - 2012
  • Start date
E

E. Madsen - 2012

#1
Does design only apply to "products"? Let me explain... I performed a sterilization supplier audit. The company is registered to 13485 and ON THEIR CERTIFICATE it says "The design of sterilization validation programs". The certifcate is a corporate document and not all their sites perform the design service. The dilemma is that in their quality manual it states that their company is exempt from design requirements because they don't perform design.

My question: Does design pertaint even if it is for services provided, especially since it is mentioned on their certificate?:confused:

Thank-you!!
 
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S

SilverHawk

#2
Re: Design for Sterilization Companies - The design of sterilization validation progr

The Sterilization Company should be certified to ISO 11135 for ETO or ISO 11137 for Gamma radiation. If the sterilization company is registered to ISO13485 alone, it has not fulfil any of the EU's MDD requirements.
 
E

E. Madsen - 2012

#3
Re: Design for Sterilization Companies - The design of sterilization validation progr

Yes, you are right, they are also certified to ISO 11135.

Do you have any ideas or opinions about the design controls?

Thanks!!
 
M

MIREGMGR

#4
Re: Design for Sterilization Companies - The design of sterilization validation progr

A sterilization company is in essence a contract manufacturing-service provider...not conceptually different from other contract manufacturers.

As such, a certain parallelism of definitions must exist.

Normally, a contract manufacturer is (by contract and by FDA definition) not responsible for the design of the product, per se...unless they also were contracted to provide product design services. A 13485/MDD analysis, I think, would generally be similar.

However, a contract manufacturer usually is responsible for the design of the process that they will use to manufacture whatever they were contracted to make.

This usually includes making engineering decisions as to how to successfully validate that process. The product's marketer usually has primary regulatory responsibility for the validation of the contract manufacturer's processes, to the extent that such validation is required...but usually it's the contract manufacturer that actually does that validation.

A sterilization company usually is responsible for the design of the process they use to accomplish sterilization. That process design is non-trivial, both practically and from a regulatory perspective. This usually includes making engineering decisions as to how to successfully validate that process.


Thus I'd think that design controls do apply.

Of course, that process design/engineering work might be concentrated at one or a few locations of a multi-location company.

In this instance, I'd think the company's current quality manual is incorrect.
 
M

MIREGMGR

#5
Re: Design for Sterilization Companies - The design of sterilization validation progr

On the other hand...I'm not a 13485-legalisms expert, which I think is the nature of the question you might really be asking. My answer is based on FDA-thinking, which tends to be more practically oriented.

In that regard, you should see this current thread http://elsmar.com/Forums/showthread.php?t=32016.
 

Doug Tropf

Quite Involved in Discussions
#6
Re: Design for Sterilization Companies - The design of sterilization validation progr

A sterilization company usually is responsible for the design of the process they use to accomplish sterilization. That process design is non-trivial, both practically and from a regulatory perspective. This usually includes making engineering decisions as to how to successfully validate that process.
We are a contract sterilizer and have excluded design and development from our QMS. While we do offer guidance on sterilization cycle development, the responsibility for approving the use of the resulting validated cycle rests with our customer(s) - the product manufacturer.
 
M

MIREGMGR

#7
Re: Design for Sterilization Companies - The design of sterilization validation progr

We're a customer of a multi-state sterilization contract-services provider. We're just completing a re-validation with them...negotiating some wording in the final report. Both we and they will sign off on it.

My perception is that we have shared responsibility for regulatory compliance, including process design and validation. Based on the both-parties-sign-off approach, which is their standard corporate practice, I think they perceive that as well.

It's clear that the FDA regards contract sterilization-services providers as a special case of the contract manufacturer class, in that they are subject to regular FDA inspection and oversight when a regular fabricate-and-assemble contract manufacturer would not be. I've been under the impression that that "special case" status extended to a regulatory expectation that such service providers were "the experts" on sterilization process design and validation, and as such had shared responsibility for those necessary elements of the sterile-product manufacturing process.

My understanding has always been that if you have shared responsibility for something, it has to be included in your QMS. But, that's theoretical.

A few months ago, we (peripherally) participated in an audit of our sterilization-services provider by our largest customer. I guess I should check with our Quality Manager and see if he paid attention to that aspect of their QMS.
 

Doug Tropf

Quite Involved in Discussions
#8
Re: Design for Sterilization Companies - The design of sterilization validation progr

It's clear that the FDA regards contract sterilization-services providers as a special case of the contract manufacturer class, in that they are subject to regular FDA inspection and oversight when a regular fabricate-and-assemble contract manufacturer would not be. I've been under the impression that that "special case" status extended to a regulatory expectation that such service providers were "the experts" on sterilization process design and validation, and as such had shared responsibility for those necessary elements of the sterile-product manufacturing process.

My understanding has always been that if you have shared responsibility for something, it has to be included in your QMS. But, that's theoretical.
We are certified to 13485 and have been through numerous FDA inspections and the way we address cycle validations has never been an issue. I am presently doing a gap analysis on the requirements of the new ISO 11135 so it will be interesting to see what comes out of that.

I believe the operative portion of your thread (quoted above) is "shared responsibility". We have always clearly stated in our contracts and other documentation that the ultimate responsibility for the effectiveness of a validated cycle rests with the customer. That being said, I can appreciate your interpretation on the issue as well.
 
J

jscholen

#9
Re: Design for Sterilization Companies - The design of sterilization validation progr

I don't think the word "design" as they use it is applicable to Design Controls. They are not designing the product, they are designing a process for customers. This would fall under process validation and not design controls.

The customer would have a sterilization requirement for thier product and have a responsibility to validate their packaging to that requirement. The Sterilizer would help design the process(since they are the experts) around the packaging configuration and then do a process validation for the sterilization process, then the customer would have to Validate their Design of Packaging to ensure their product is sterilized, etc... hence sterilizer is not responsible for design of product, just process validation to meet the customer requirement for sterilized product. Whether the packaging can maintain a sterile barrier is the customer problem, but one that the sterilizer could help them design better.

make sense?
 

Doug Tropf

Quite Involved in Discussions
#10
Re: Design for Sterilization Companies - The design of sterilization validation progr

In our case, we do not assume responsibility for the process (cycle) validation - we do have the responsibility to meet the parameters established during the cycle validation when subsequently sterilizing the family of product the customer indicates can be sterilized using the cycle.
 
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