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#1 shagenbaugh

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Posted 17 December 2015 - 06:15 PM

Is it necessary to contract a professional microbiologist to create a testing program, or is it something we can design on our own (assuming it is scientifically sound)? 

 

I am attempting to develop our Environmental Monitoring swab program and was wondering if anyone had specific pathogen agars they exclusively worked with. We are a dietary supplement ingredient/food and beverage ingredient facility. 



#2 Charles.C

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Posted 17 December 2015 - 07:30 PM

Is it necessary to contract a professional microbiologist to create a testing program, or is it something we can design on our own (assuming it is scientifically sound)? 

 

I am attempting to develop our Environmental Monitoring swab program and was wondering if anyone had specific pathogen agars they exclusively worked with. We are a dietary supplement ingredient/food and beverage ingredient facility. 

 

Hi Shagenbaugh,

 

I would say you can do it in-house provided that you have adequate technical resources and appropriate sampling/analysis procedures for yr specific product/process/target micro parameters.

 

Many generic models exist in the literature (and on this forum) with foci on various pathogens like Listeria spp, Salmonella spp and indicators like Enterobacteriaceae, the choice often related to the product/process. No doubt  models for the food & beverage industry have also been published.

 

The usual sampling approach is via zones based on a risk assessment for the particular product/process layout. The agar media will obviously depend on the choice of target micro. species/indicator/procedure.

 

Just as an example, a general Canadian sampling procedure is attached in this post  –

 

http://www.ifsqn.com...wab/#entry96582

 

There are many other, some pictorially rich, more detailed examples on this forum.

 

PS - Welcome to the Forum ! :welcome:


Kind Regards,

 

Charles.C


#3 BrummyJim

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Posted 18 December 2015 - 09:09 AM

Be aware that many customers won't accept the results unless the lab is ISO17025 accredited. M&S in the UK (and us) for example. ISO17025 accreditation is achievable, but most internal manufacturing labs prefer not to due to the strict regime required (I believe you need to have a resident microbiologist). It's often easier to test internally for TVC, Ents and Yeasts & Moulds and put the rest out to an accredited lab.



#4 Simon

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Posted 18 December 2015 - 09:35 AM

I agree with Brummy Jim.  You can do it if you have the in-house competence; however, demonstrating competence is usually through some sort of formal accreditation such as ISO17025.  It’s what customers and 3rd part auditors look for.

 

Good luck and welcome to the forums.

 

:welcome:

 

Regards,

Simon


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#5 Charles.C

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Posted 18 December 2015 - 09:42 AM

But, afaik, if yr customer will accept certification  to BRC7, the latter does not require laboratory accreditation to  iso17025

(5.6.2.3)

 

IMO, capability to safely do pathogen testing in-house vastly expands yr monitoring power. But it's a potential 2-edged sword.


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Charles.C


#6 Simon

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Posted 18 December 2015 - 09:47 AM

Can you copy the contents of 5.6.2.3 Charles?


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#7 BrummyJim

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Posted 18 December 2015 - 09:58 AM

I suppose the first question to ask is does your proposed pathogen lab conform to the BRC requirements in section 5.6? Is it fully segregated with procedures to prevent any risk of cross contamination? 

 

Then you have to ask if you want to have pathogens present in your factory to complete the daily testing required in a lab. These are the positive/negative daily tests to demonstrate that the tests used are valid. You need to have samples of every bug you're testing for, kept under controlled conditions.

 

Then there's the swabbing of the lab to show that there's no potential for pathogen cross contamination.

 

Ring testing shouldn't be an issue as LGC and similar support that. You will need to have qualified staff to run the lab with access to a microbiologist.

 

And finally (probably not, there,s always more) you need the quality manual, which needs to be maintained with the associated records and training.

 

Most companies look at the above and decide that an external lab is less effort!



#8 Charles.C

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Posted 18 December 2015 - 09:59 AM

Can you copy the contents of 5.6.2.3 Charles?

 

Hi Simon,

 

Where the company undertakes or subcontracts analyses which are critical to product safety or
legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or
operate in accordance with the requirements and principles of ISO/IEC 17025. Documented
justification shall be available where accredited methods are not undertaken.


Kind Regards,

 

Charles.C


#9 Charles.C

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Posted 18 December 2015 - 10:04 AM

I suppose the first question to ask is does your proposed pathogen lab conform to the BRC requirements in section 5.6? Is it fully segregated with procedures to prevent any risk of cross contamination? 

 

Then you have to ask if you want to have pathogens present in your factory to complete the daily testing required in a lab. These are the positive/negative daily tests to demonstrate that the tests used are valid. You need to have samples of every bug you're testing for, kept under controlled conditions.

 

Then there's the swabbing of the lab to show that there's no potential for pathogen cross contamination.

 

Ring testing shouldn't be an issue as LGC and similar support that. You will need to have qualified staff to run the lab with access to a microbiologist.

 

And finally (probably not, there,s always more) you need the quality manual, which needs to be maintained with the associated records and training.

 

Most companies look at the above and decide that an external lab is less effort!

 

Hi Brummy Jim,

 

It  likely depends on factors like location / product / process / destination.

 

eg Japanese customers often  demand full micro. data on every batch.

 

No data = no business. It's a strong motivation to invest in analytical techniques.

 

Also for some Companies, it's simply a question of Policy.

 

But I agree you do need microbiologists, etc. = Technical Resources.


Kind Regards,

 

Charles.C


#10 BrummyJim

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Posted 18 December 2015 - 10:11 AM

Charles,

 

I agree. If the business justifies it, then do it. However, it's not a simple job, and there are risks involved such as holding samples of Listeria, Salmonella etc. to demonstrate that your lab results are valid for that day. I spent 3 years in a food testing lab, and its no fun if one of your tests fails as you must re-test everything for that method. Would a smaller lab find it easy to supply the resource to do that? It's not reading the plates that take the time, it's preparing the sample.



#11 trubertq

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Posted 18 December 2015 - 12:52 PM

It's a costly and potentially dangerous road to go down in a manufacturing facility, bearing in mind that you must hold live cultures of pathogens for positive controls. 

 

By all ,means carry out the routine TVC etc... stay well away from the pathogens unless you have a dedicated separate facility with the required level of containment.

 

Don't carry out microbiology without a trained technician, there is a reason we have been trained, ..... would you let an accountant do your plumbing?

 

The outlay for a dedicated pathogen testing laboratory will in the end prove prohibitive I would have thought, never mind the added Quality Manuals, ring testing, proficiency testing calibrations etc...

 

I set up a testing laboratory in the early 90's and it was no joke, it's still going by the way....I doubt equipment has become any cheaper!!


I'm entitled to my opinion, even a stopped clock is right twice a day




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