Sterile vs. PCR Performance Tested Plastic Products

[Rocke]

Quick question, because I am not really able to interpret the information my supplier is giving.

We have so far placed our liquid products in sterile plastic vials.
Our manufacturing dept. wants to change supplier of vials, to a product that is not sterile but PCR performance tested. The supplier states

"The PCR performance tested vials are cleaner than the sterile vials but have not been sterilized. We have refined the production requirements for non-sterile PCR products. Skilled personnel, clean room conditions along with automated production processes enable contamination-free manufacturing."

Our products are not sterile, but preserved liquids. We have used sterile vials to minimize bio burden, but sterility is not a requirement for the product.

Does anybody have any insight about the risk of contamination in PCR performance tested plastic ware opposed to sterilized plastic ware?

Any input appreciated.
Camilla

 

[Marc]

PCR = Polymerase Chain Reaction?

 

[Rocke]

PCR = Polymerase Chain Reaction?

Yes, sorry.

 

[pkost]

I'll clarify this by saying I am not a bio scientist and don't understand much about PCR

With that said...how important is excluding particulates from your vials? you say the sterility isn't an issue, but I would have thought it is as non sterile product may contain DNA, but that's just my ignorance of the process.

I would be wary of the marketing blurb..."contamination-free"?!?! if it's non sterile it obviously isn't contamination-free! if bioburden can be on the "contamination-free" vials, I'm pretty sure other things can be too!

 

[Rocke]

I'll clarify this by saying I am not a bio scientist and don't understand much about PCR

With that said...how important is excluding particulates from your vials? you say the sterility isn't an issue, but I would have thought it is as non sterile product may contain DNA, but that's just my ignorance of the process.

I would be wary of the marketing blurb..."contamination-free"?!?! if it's non sterile it obviously isn't contamination-free! if bioburden can be on the "contamination-free" vials, I'm pretty sure other things can be too!

OK, we do not offer our products as sterile. We do not have facilities to guarantee sterile production, and as the liquid is added preservatives, sterility is not required.
In terms of particulates, we are happy with "manufacture clean vials".
THe issue is that the product is a protein liquid, which is a suitabl growth media for a lot of microorganisms. The preservative added is effective up to a certain load of microbial challenge load. THe concern is that non-sterile vials could contain a load to high to render to preservation effective.

My question is whether viable microbes will be present on PCR-grade plastic?

Camilla

 

[pkost]

the definition of sterile is that there are zero viable microorganisms. Therefore if something is not sterile it may have viable microorganisms on it.

Sterility is an absolute, it either is, or isn't - there is no halfway. They say that they have not been sterilised, therefore they cannot claim the vial is sterile (which they don't)

 

[Rocke]

Thanks for your input.

I'm not looking for a definition of sterility, but for anybody with insight into PCR performance tested products. I would assume that absence of DNA would also mean that no viable organism could be present, but I am not sure.

Camilla

 

[Ronen E]

Thanks for your input.

I'm not looking for a definition of sterility, but for anybody with insight into PCR performance tested products. I would assume that absence of DNA would also mean that no viable organism could be present, but I am not sure.

Camilla

Hi,

Not a PCR expert either, but to me it is an issue of proper purchasing controls:

Ask the what levels of bioburden / DNA matter / "whatever" they are willing to commit to in a supply contract; Ask them to provide CoT's with every lot; and challenge them with your own preferred 3rd party lab for the first lots, until you gain confidence (5 lots minimum, 10 better, 15 or more - best).

Once something concrete is put into a contract, market-speak is eliminated and suppliers usually commit only to what they can really sustain.

Cheers,
Ronen.