Allergen Testing
What is everyone doing for allergen testing? Are you testing in-house? Or sending a sample to a lab?
Both in-house and lab. You need to start with an appropriate validation study that your cleaning methods are doing the job of removing allergens from your equipment. Once you have quantitative data to support your methods, inhouse qualitative tests can be used. Annually I send out to a lab just to make sure that all is still in the same scope. Take note that all swabs collected are prior to a sanitizer step.
Both. Lots of lateral flow kits used in-house for the quick results turn around to verify sanitation, with some finished goods samples sent to third parties for validation.
Do you mind sharing which in house kits you are using? I have a great lab that I send other samples to.
Do you mind sharing which in house kits you are using? I have a great lab that I send other samples to.
Hygiena and/or Neogen/3M all lateral flow qualitative.
They're all 3M/Neogen internally.
The labs are largely using the ELISA kits from the same suppliers. Some of those details came out when the shortage on them was bad.
Always sent them off site for validation (also with a positive spike sample to ensure the allergen can be recovered). Note that Neogen themselves recommend validating what level the lateral flow can detect in your product. Don't assume it will be at the "typical" levels on the paperwork. I would only use the rapid swabs for some level of monitoring or verification of cleaning, but unless your process or product is particularly sensitive, I would be less reliant on rapid testing than a good inspection with eyes, nose etc! I know, old fashioned, but if you have trace levels on a surface, a rapid swab might not detect it and if you have gross levels you can often see it.
Where I have found them useful is the lab swabs can have slow turnaround times so with new equipment as you're trialling cleaning processes, I've often used rapid swabs as a quick and "dirty" check for gross failure before sending off the ELISA tests. Not all that scientific, RSSL did not approve I'm not going to lie but it did help a little bit.
Both tests me also... One or two per year to the lab and 6 to 8 in house
Daft question... I trawled the UK retailer standards years ago and came up with a best practice process for allergen validation which included the following:
A "spike" positive control product sample
First sample off the line post clean product sample
A positive control swab pre cleaning
Negative swabs in triplicate post cleaning (I think I chose 2-3 points)
All by ELISA. So not cheap but also seemed to be the requirements we were expected to meet. But the point being it's validating that "visually clean" is actually "allergenically clean". So not doing loads of rapid swabs.
It might seem excessive but as allergen is one of the leading reasons for recalls (albeit more likely to be wrong ingredient or wrong packaging) I've never struggled to get senior leaders to approve the spend.