Hi All,
I'm yet another person looking for guidance on microbiological sampling plans...I've done my best to review previous topics on the board but I still don't have a solid grasp on how to design a representative system. I'll hash out some info about our process:
We are a dietary supplement facility focused on freeze-drying plants to create powders. These powders are then bottled as loose powder (ie for smoothies), or encapsulated into HPMC capsules. We currently have 3 points of sampling:
- Raw Material delivered to plant
- Batch of freeze-dried powder after the drying process
- Finished product, bottled and labeled
Currently we take one 50g sample at each of these points, for each lot. In other words, each lot of raw material, in-process material, and FG gets one sample. Of course, this presents an issue because the sample size does not vary depending on the batch size. And as always, a big challenge for us is the lack of resources to significantly increase our testing.
We test:
APC, Coliform, Ecoli, Yeast, Mold, and Salmonella on these samples. Soon, for the powders we will test water activity. Sal/Ecoli have zero tolerance for detection in our product, while APC/Coli/YM are based on spec limits.
To increase testing but stay within our means, I'm thinking of increasing the sample size of in-process material and raw-material testing based on poundage of material. FDA standards require that representative samples are being collected (111.105[f]). Given that the number of samples would vary based on batch size, is this compliant? For example, if 1 sample is collected per 100lbs of freeze-dried material, we'd collect 3 samples from 300lb run. Guidance on compositing these samples would be appreciated too...if we could composite the three samples as one test that would be great.