2 replies to this topic

[RazM4tt]

Im currently re-evaluating the program at my company and the APC limits that we are adhering to. Right now we are doing zone 1 <100, zone 2 <100 and Zone 3 <100.

 

We are a near-pharmaceutical grade production facility (powders/liquids/encapsulation) and want to maintain tight standards however zone 3 keeps failing in routine areas (such as right at the entrance to a production room). I understand we want to catch zone 3 before it spreads, but having the same standards for zone 1 as zone 3 seems a little off to me. I dont want to just stop swabbing that spot knowing that it will fail (most recently got 220). We work with mostly plant materials and adhere to mostly "green" production (ie, we use simple green to do our cleaning and other environmentally friendly chemicals). Its also frustrating that if someone simply steps into a room or doesnt wipe a certain item on the wall, I am now dealing with corrective action reports. How absurd would it be for me to propose raising the zone 3 limit (im thinking 200 or 250), what limits have you seen in similar production facilities? Thanks, have a great week yall!

[Evans X.]

Greetings RazM4tt,

 

It depends if zone 3 is high or low risk. That's the first you need to work out first.

Assuming that it is low risk, I have seen many examples of having the limit for APC up to 1000 cfu / cm². The reasoning is that APC is a hygiene indicator and not an actual health risk source, meaning that if you are off limits from the set value you should start checking for other microorganisms also, like Enterobacteriaceae, E. coli, Yeasts - Molds, maybe even Listeria. There are only suggestions on this and nothing specific in legislation.

 

Regards.

[RazM4tt]

Greetings RazM4tt,

 

It depends if zone 3 is high or low risk. That's the first you need to work out first.

Assuming that it is low risk, I have seen many examples of having the limit for APC up to 1000 cfu / cm². The reasoning is that APC is a hygiene indicator and not an actual health risk source, meaning that if you are off limits from the set value you should start checking for other microorganisms also, like Enterobacteriaceae, E. coli, Yeasts - Molds, maybe even Listeria. There are only suggestions on this and nothing specific in legislation.

 

Regards.

 

So currently Im performing after sanitation swabs and in a small (140 sq ft) room, I have it set to minimum of 5 (we were doing 10 but it was overkill and expensive) swabs for zone 3. For zone 3 we do APC/coliform/salmonella + Listeria. APC Limit is 100, and Coliform limit is 50. I think I will leave the limits alone and simply stop swabbing the entryway of the rooms. Deeper into the rooms may be more logical for me, so that if something is detected I know how far into the room it is making it. Thank you for the feedback and advice!

Edited by RazM4tt, 26 February 2024 - 01:41 PM.