SGquality

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#1
We are in discussion with a pharmaceutical manufacture for manufacture of plastic primary drug containers.

The customer wants these plastic injection molded primary containers to be molded in ISO Class 7 area as the Class 7 clean rooms have lower particulates while we feel that ISO Class 8 would suffice. The molded plastic containers would be molded, washed, and then sterilized, and the customer would fill drug product aseptically in these containers.

Are there any regulations / standards that would help me in this direction? Also are there are testing criteria for the molded plastic containers to be used exclusively by the drug industry?

Appreciate your help.
 
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chris1price

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#2
Hi
To answer your last part first, I don't believe there are any regulations or standards that would give you guidance or any specific testing. I would suggest a great deal depends on your validation of the processes, Washing, packaging and sterilisation.

I was ok with saying Class 8 until you mentioned aseptic filling by the pharma company. The regulatory expectations for aseptic filling are increasing continuously, a complete revision is expected this year. Consequently, I am not surprised they are asking for Class 7, or more likely Grade C.

One final thought, if this is an existing product and the customer wants you to upgrade from Class 8 to 7, that's always an opportunity to pass a cost increase to the customer.

Chris
 

SGquality

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#3
Hi
To answer your last part first, I don't believe there are any regulations or standards that would give you guidance or any specific testing. I would suggest a great deal depends on your validation of the processes, Washing, packaging and sterilisation.

I was ok with saying Class 8 until you mentioned aseptic filling by the pharma company. The regulatory expectations for aseptic filling are increasing continuously, a complete revision is expected this year. Consequently, I am not surprised they are asking for Class 7, or more likely Grade C.

One final thought, if this is an existing product and the customer wants you to upgrade from Class 8 to 7, that's always an opportunity to pass a cost increase to the customer.

Chris
Thanks Chris.

This is a new product and the client is a startup company and they want us to mold in Class 7 based on what they heard from someone in their circle. Volume 4, Annex 1 (Manufacture of Sterile Medicinal Products), states that "Components after washing should be handled in at least a grade D environment". I was banking on this statement that the plastic containers can be molded in Grade D and also after washing be handled in the same environment.

When you say, a revision in the aseptic filling document is expected this year, which document are you referring to?

Thank you for your help :thanx:
 
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chris1price

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#4
Hi, The revision to Eudralex Vol 4, Annex 1 (GMP Guidelines, Manufacture of Sterile Medicinal Products) was published for comment at the end of Dec 2017.

https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf

Revision of Annex 1 "Manufacture of Sterile Medicinal Products" published for Comments - ECA Academy

It still requires substantial editing, but is likely to come into effect in the next 6 months or so. There is a lot of debate about the content, but it is a lot more coherent then than the existing Annex 1. While the final version may be watered down a little, is is likely to be significantly tighter than the 2008 version.

I appreciate this doesn't directly affect US regulations today, but it shows the general ratcheting-up of compliance requirements.

Unfortunately, there is nothing here that directly answers your question. It is just the continuous tightening of regulations that makes me suspect class 7 would be the preferred option in the long term.

Chris
 
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chris1price

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#5
Since writing my previous response, I discussed this with colleagues. A consensus was that class 8 would probably be acceptable provided that the processes were fully validated.

Chris
 

SGquality

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#7
Since writing my previous response, I discussed this with colleagues. A consensus was that class 8 would probably be acceptable provided that the processes were fully validated.

Chris
Is final rinse with WFI after plastic drug containers are molded and before wrapping for sterilization, an absolute requirement ?
 

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