Nov 1, 2007

Handling samples

As part of our company growing up, and failing a sterility test, we've put the quality department in charge of samples instead of manufacturing. In most companies I've seen, quality generally handles various samples and installs things like biological indicators (spore strips) and other special sample conditions. For us, manufacturing was doing it because the QA/QC department was stretched thin, but now somehow we have acquired more quality personnel than manufacturing personnel. A situation which immobilizes manufacturing at least 2 out of every 5 days and has 50% of them threatening to quit regularly.

Anyway, I mentioned spore strips because I wanted to detail the fun of using them. First off, if you can, use the ones in the glassine envelopes. However, for some reason, they make smaller and different shaped spore indicators, but leave them in the large envelope. This means you may have to use a type that does not come in the envelope or open the envelope and insert the sample into your product. If you own a BI company I see a market opportunity, or maybe I just can't find them and everyone else knows about them.

Because nothing is ever easy, we of course have to use the non-enveloped indicators. My first instinct is that you don't want to do this in the clean room, that seems to be just asking for trouble. (ASFAIK not a problem with the enveloped ones) One of the afore mentioned "quality" personnel will drop one on the floor and then step on it and track it around the room and we'll have to spend the next week disinfecting. Instead, manufacturing is going to bag the product and remove it from the clean room and masked and gloved QA will insert the spore indicators under a fume hood with sterile instruments as needed. They will then rebag the product and seal it immediately outside of the clean room. I ruled out using a clean bench instead of a hood because the air blowing out (instead of up) is more likely to disperse bacteria, most likely right on to the person doing the indicator placement, although I'm not sure how much I should be worried about that. I'm not very happy with this procedure and might rework it on a whim as I think more about it. Moving the product out of the clean room for the prep is likely to add some bioburden to it, although it shouldn't be much and surface bioburden is probably easier to kill, its still better not to have it in the first place.

PS I might sometimes sound mean and sarcastic to readers, but those who know me know I'm only sorta joking and don't take myself too seriously!


Anonymous said...

You can ask your sterilization company to inoculate your samples for you at their facility. This will eliminate the chance of contaminating your controlled environments and/or fume hoods.

Anonymous said...

why do you have to inoculate the products? i understand in the case of a avlidation, but routine control only needs to place the PCD at challenging positions throughout your pallet (hard to reach areas for tÂș and Rh)