5 replies to this topic

[sprout.derek]

Hello, currently trying to put together a RA for a plastic packaging plant. Not sure where to start. As I understand it, plastic surfaces are not condusive to bacterial growth, so I do not believe we have any actionable risk. Just not sure where/how to justify this.

 

Currently conducting air sampling for Yeast/Mold and TVC's, and used to test for Salmonella (before we realized there was no risk). 

Edited by sprout.derek, 08 December 2023 - 07:48 PM.

[nguyen191086]

Hello; 

You should have a standard for your product (reference the National standards, and customer's requirements). Based on this standard, you define all hazards that could contaminate your products. 

[aldehit75_murat]

Hello, the contamination is not in-process, it can also be human-induced. You should first check whether the production environment is dry or humid and accordingly which pathogenic or non-pathogenic micro-organisms are present. 

Edited by aldehit75_murat, 10 December 2023 - 05:10 PM.

[aldehit75_murat]

Hello sprout.derek , the contamination is not in-process, it can also be human-induced. You should first check whether the production environment is dry or humid and accordingly which pathogenic or non-pathogenic micro-organisms are present. 

Edited by aldehit75_murat, 10 December 2023 - 05:07 PM.

[Scotty_SQF]

Work on having and referencing scientific information that shows no growth on plastic.  Ask your suppliers for their answer and information on Microorganism growth and their product.  You can use that as part of your risk assessment.  No water used in the process and dry cleaning?  Another item that can be used to risk assess.  I have gone as far as swabbing some of the product contact surfaces, receiving results ( all negative or below specified limits) and used that as a basis to prove there is no risk (Slightly risky to do because if you find something there goes your risk assessment out of it).  For staff focus on GMP's.  Use a standard risk assessment matrix, to show there is virtually no risk and then follow up with a statement saying because of X,Y, & Z you feel there is no risk thus there is no need for a scheduled environmental swab.  I would also throw in that should the process, raw materials, etc. changed that this will be reevaluated.  Hope that helps.

[jfrey123]

My development of the EM would depend on your historic data of those air plates.  Good indicator data coming from them if they're all clean, limits the potential of airborne concerns and leaves you free to determine if equipment swabbing reveals trends of concern.  You can bundle a summary of that data together and, if it's showing no issues over a period of say 6 months to a year, I'd justify no EMP program or at least a quarterly check at worst.