Microbial Filtration CCP
At one point, we are filtering hydrogel through 0.2 micrometer filter in order to sterilize the hydrogel for using in Bioprocessing. I am highly confused if it is CCP or OPRP or just PRP. Can someone give very logical input here? I would highly appreciate. Thanks.
my take would be this.
if your hazard analysis indicated a biological risk and filtering is the method to control the risk, it is a ccp.
Hi Thanks for your answer. We are using o.2 micron filter for removing microorganisms. In this sense, it is for Biological hazard elimination. But, if mark it as CCP, what will be the critical limit? Because, here no parameters is for real time monitoring.
Are there specific organisms you're targetting with the filtration? If these are spoilage rather than pathogenic, then arguably it isn't a CCP as it's not related to food safety.
It's generally fairly well accepted that there are some CCPs for which real-time monitoring isn't feasible, so that element shouldn't be a problem as long as the associated checks and actions are sufficient to address the problem if a failure is found (e.g. checking at the end of the batch, before the product is released from production).
As for how to test, what type of filter is it?
I'd suggest discussing this with your filter supplier, as for various types of filters of this size there are a range of potential ways to test integrity - e.g. pressure hold/decay, flow tests, bubble point tests etc.
Hi thanks for your answer. But one think is really confusing. it is the concept of pathogenic and spoilage/non pathogenic bacteria. But, to my understanding, spoilage point should also be a CCP. Because, when spoilage occurs, certainly there is above the limit of aerobic plate count/mesophilic bacteria. A per regulatory rules, we must have to control it. So, why it will not be CCP?
HACCP is generally focussed on things that could potentially cause harm to consumers, and spoilage organisms wouldn't typically fall into this category - these are generally bacteria/yeasts/moulds that might make something unpleasant, but won't hurt someone.
Similarly, the EU regulation relating to microbiological limits (2073/2005) generally sets limits for pathogens, with the exception of "indicator" organisms that might not themselves be pathogens, but could be indicative of a broader microbiological issue such that pathogens may be present at unacceptable/dangerous levels.
You are in an interesting position in that theoretically your 0.2μm filter should address both pathogens and spoilage organisms, so if you do have any spoilage then that in itself indicates that the process almost certainly hasn't worked correctly, but I wouldn't consider the spoilage organisms themselves to be a hazard. If the product is not capable of supporting growth of pathogens (e.g. due to pH, water activity, alcohol level etc) then spoilage is an operational problem for you, and potentially a shelf-life problem, but not generally a HACCP-related problem.
If you're new to HACCP then I'd very much recommend taking a course on it to get a better feel for it, as it is much easier to get to grips with it once you've got more training and understanding behind the idea of what it is used for an how to best apply it.
Is this Codex HACCP or iso-haccp ?
It matters.
Since we are not going to get any certification for ISO standards, but for a regulatory reason. So, it's Codex HACCP.
Kind Regards
Mazid