Greetings
Im using manual capsule filling machine for supplements manufacturing.
The procedure is weighing the powder in the cup then empty it in the machine tray.
In this case, can we use any kind of plastic bottles during the production process so the powder gets in Contact with the plastic Bottles, is it allowed in the GMP? instead of using stainless steel cups?
Is there any reference available for allowing pvc use in pharma production?
It depends. While you are making a ‘Dietary Supplement’ you are still regulated by the FDA (Office of Dietary Supplements in fact). You can CYA by signing a ‘Confidential Disclosure Agreement’ with the plastic bottle supplier in order to obtain their extractable and leachable list.
In case of ‘cleaning validation’ I would use TOC in this case. However, the plastic scoop is dedicated and not a source of cross contamination.
It looks as though there are two discussions started about this topic on this forum right now.
Here is the FDA statement about material compatability - as you can see, they don’t state whether stainless or plastic is required.
Sec. 211.65 Equipment construction.
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
The only GMP requirement is that packaging and processing equipment do not add to, react with, or take from the product. How that happens is up to you. Each product is unique. I’ve had a product which Stainless reacted with the product, and so we had to go to plastic. I’ve had other products where the product would absorb into the plastic, and had to go to stainless.
Here is a FDA published discussion on that.
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM456371.pdf
So you might have to do a material compatability study to determine if plastic is OK. THis can be done via literature search, contacting the supplier of the material you are weighing, or a laboratory study. Also there are a variety of plastics. PVC, PTFE, etc. I suspect that a liquid would have more adsorobtion issues than a powder, but you’ll have to confirm for yourself.