11 replies to this topic

[foodie13]

I work for an alcoholic and non-alcoholic beverage company where we pasteurize then cold fill into aluminum cans. Location is United States. 

 

Management is pushing to bring finished product micro testing in house to save costs on outside lab. The pathogen testing will be a fairly new program for us either way.  

We do currently have an in house micro lab testing for beer spoilage type organisms. 

 

I'm concerned with this proposal to bring in house due to:

• I assume we would need to grow positive controls to validate our testing
• Keeping positive controls isolated from the rest of the facility (and handling protocols)
• We aren't a certified lab, so would our results really hold any weight legally?
• I am not aware of any companies doing this testing in house

Our customers are all small brands that do not have their own specific requirements for testing. 

 

Does anyone have any input on doing in house finished product pathogen testing and if our results would even be worth the paper they're printed on from a regulatory standpoint? 

[Scampi]

Are you certified under a GFSI?  

 

If so, the lab cannot share a door with production and must be kept locked at all times

 

Do you have an autoclave?  If not you'll need one

 

You will also need an incubator, plate reader, plates pipettes etc and training on a standardized protocol (that needs to be validated annually) (none of this is inexpensive)

 

I worked at a facility where we did in-house pathogen testing, BUT it was designed that way so that it was physically separate from the production floor.  All plates were put in the autoclave once read for destruction.

 

QC employees were on a rotation, so if they were in the lab on any given week---they DID NOT go on the production floor for any reason

 

3M has a great system for this purpose--but again not cheap---it would be worthwhile giving management some hard facts/prices just on equipment and consumables so they can see if it will actually save them money in the long run

[foodie13]

We are working towards becoming SQF certified. 

The micro lab currently has an external entrance and is not connected to any production areas, however, we do have plans to move it into the main plant soon.. Which I already flagged as a no-go if we continue with pathogen testing.

 

We do have a incubators, pipettes, plates etc already as we do spoilage micro currently. All plates are counted by eye at this time, not using any automation. 

 

We definitely do not have the ability to have someone designated as "Micro lab only" on any given day or week. Our QA department is very small and we all go in and out of the plant on the regular. No uniforms are in use either, so changing clothes isn't even an option at this time. 

 

In your facility were you maintaining positive control samples or did you have a work around for that?

 

[Scampi]

No, we didn't keep any samples ever--we didn't need to (raw poultry)

 

So you've got some work to do before you can go ahead

 

Lab personnel need to have PPE for the lab---they cannot walk out on the floor after being in the lab

 

See the SQF requirements below---note**  As this is from Module 2, you cannot exclude the elements below

 

2.4.4 Product Sampling, Inspection and Analysis 2.4.4.1 The methods, responsibility, and criteria for sampling, inspecting, and/or analyzing raw materials, work-in-progress, and finished product shall be documented and implemented.

The methods applied shall ensure that inspections and analyses are completed at regular intervals as required and to agreed specifications and legal requirements.

Sampling and testing shall be representative of the process batch and ensure that
process controls are maintained to meet specification and formulation. 2.4.4.2 Product analyses shall be conducted to nationally recognized methods or company requirements, or alternative methods that are validated as equivalent to the nationally recognized methods.

Where internal laboratories are used to conduct input, environmental, or product analyses, sampling and testing methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses.

External laboratories shall be accredited to ISO/IEC 17025, or an equivalent international standard, and included on the site’s contract service specifications list (refer to 2.3.2.11).  2.4.4.3 On-site laboratories conducting chemical and microbiological analyses that may pose a risk to product safety shall be located separate from any food processing or handling activity and designed to limit access only to authorized personnel.
Signage shall be displayed identifying the laboratory area as a restricted area,
accessible only by authorized personnel. 2.4.4.4 Provisions shall be made to isolate and contain all hazardous laboratory waste held on the premises and manage it separately from food waste. Laboratory waste outlets shall at a minimum be downstream of drains that service food processing and handling areas. 2.4.4.5 Retention samples, if required by customers or regulations, shall be stored according to the typical storage conditions for the product and maintained for the stated shelflife of the product. 2.4.4.6 Records of all inspections and analyses shall be maintained.

[kingstudruler1]

if I was going to test for pathogens, I would definitely look into something like the 3M MDS.   

 

 

3m-molecular-detection-systems-full-line-brochure.pdf

 

 

One of my clients put one of these in their facility when we updated their EMP program.   they love it.   They have had no issue with auditors or regulators, but you do have to address the items Scampi has outlined.   

[Charles.C]

I work for an alcoholic and non-alcoholic beverage company where we pasteurize then cold fill into aluminum cans. Location is United States. 

 

Management is pushing to bring finished product micro testing in house to save costs on outside lab. The pathogen testing will be a fairly new program for us either way.  

We do currently have an in house micro lab testing for beer spoilage type organisms. 

 

I'm concerned with this proposal to bring in house due to:

• I assume we would need to grow positive controls to validate our testing
• Keeping positive controls isolated from the rest of the facility (and handling protocols)
• We aren't a certified lab, so would our results really hold any weight legally?
• I am not aware of any companies doing this testing in house

Our customers are all small brands that do not have their own specific requirements for testing. 

 

Does anyone have any input on doing in house finished product pathogen testing and if our results would even be worth the paper they're printed on from a regulatory standpoint? 

Hi Foodie,

 

The answers may depend on what pathogens you intend to handle and the subsequent Biosafety Level Classification, eg -

 

https://www.labmanag...s-1-2-3-4-19123

 

I anticipate yr current Level is 1 but would minimally change to Level 2  for pathogens like Staphylococcus aureus COP, L.mono and most (some are 3) Salmonella spp.

 

I'm not in USA but have experience where a sister Company was. Our lab routinely tested for some of the above food pathogens but US lab refused to initiate due concern over possible cross-contamination and related legislative aspects. This was stated to be typical of their Industry.

 

And yes, positive controls are usually unavoidable and in some cases, eg Vibrio spp, not always readily available.

 

There are obvious time advantages (and sometimes self-confidence) regarding analytical results but IMEX micro. work can sometimes be as much an Art as a Science. Laboratory is required to be located independently of Production Area. Waste disposal can be complicated if there is substantial throughput.

 

If yr lab. is doing routine micro testing with qualified personnel most of the above is probably already well known.

 

As previous Post, nowadays the documentation of implementation of ISO 17025 Principles is often GFSI/legally, minimally, required. Some in-house Labs go for full Accreditation.

[Charles.C]

if I was going to test for pathogens, I would definitely look into something like the 3M MDS.   

 

 

3m-molecular-detection-systems-full-line-brochure.pdf

 

 

One of my clients put one of these in their facility when we updated their EMP program.   they love it.   They have had no issue with auditors or regulators, but you do have to address the items Scampi has outlined.   

Hi ksr,

 

Looks very pretty but probably involves a small fortune ?

 

Surprisingly, the basic instrument has been around for 10 years and the original setup/Procedure looked far from simple. Seems current system is much automated/streamlined.

Note that a pre-enrichment stage seems necessary which usually adds a day.

[EagleEye]

if I was going to test for pathogens, I would definitely look into something like the 3M MDS.   

 

 

3m-molecular-detection-systems-full-line-brochure.pdf

 

 

One of my clients put one of these in their facility when we updated their EMP program.   they love it.   They have had no issue with auditors or regulators, but you do have to address the items Scampi has outlined.   

 

 

 

It would actually help as a second half of the whole analysis. MDS would cost itself a $ 20K if I am assuming.

 

First half still needs all conventional micro protocols until an enriched specimen on hand.

[PQAManager]

Are you certified under a GFSI?  

 

If so, the lab cannot share a door with production and must be kept locked at all times

 

Do you have an autoclave?  If not you'll need one

 

You will also need an incubator, plate reader, plates pipettes etc and training on a standardized protocol (that needs to be validated annually) (none of this is inexpensive)

 

I worked at a facility where we did in-house pathogen testing, BUT it was designed that way so that it was physically separate from the production floor.  All plates were put in the autoclave once read for destruction.

 

QC employees were on a rotation, so if they were in the lab on any given week---they DID NOT go on the production floor for any reason

 

3M has a great system for this purpose--but again not cheap---it would be worthwhile giving management some hard facts/prices just on equipment and consumables so they can see if it will actually save them money in the long run

Scampi, You said if GFSI certified that lab doors have to be locked?  We do brix, pH, refractive index, and yeast and mold testing on our products in our lab only.  We also do research and development, and do small batches for customers in lab.  We are SQF certified.

[Scampi]

Hi Penny

 

None of those are pathogens----the poster is talking about sampling and analysis for E.coli, salmonella etc. and pose a real risk to contaminating the finished goods and/or the plant itself

 

See 2.4.4.3 in my post above

[kingstudruler1]

Hi ksr,

 

Looks very pretty but probably involves a small fortune ?

 

Surprisingly, the basic instrument has been around for 10 years and the original setup/Procedure looked far from simple. Seems current system is much automated/streamlined.

Note that a pre-enrichment stage seems necessary which usually adds a day.

 

as i recall the price of the unit was based off of a agreement to purchase X many tests.   they were going to be doing so many tests the unit didn't cost much for the unit and the cost for test was around $10.   They made it sound very inexpensive.   

 

I think the vidas has been around for decades.  

 

it is pretty to use.   

 

yes, pre-enrichment is required.  

Edited by kingstudruler1, 08 March 2023 - 07:24 AM.

[Deanna G.V]

We use the 3M MDS, and have found it difficult to use all of the lysis tubes before the assay kits expire (60 days from the time of opening) or we run out of reagent controls. For perspective, each assay kit comes with 96 lysis tubes, each sample uses 1 lysis tube, and 1 lysis tube for the negative/reagent control (keep in mind you only need one lysis tube per pathogen reagent/negative control per run). The kits only come with 16 (yes, you read that correct) reagent controls so that means you can only complete 16 runs with each assay kit. That works out to 6 samples per reagent control, to be used within 60 days...if you complete a lot of internal testing then this unit may be the way to go! I just wanted to warn you if you do not complete a substantial amount of testing!