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Requirements for Establishment of an In-House Laboratory


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#1 solrac

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Posted 15 January 2019 - 07:07 PM

Hi.

 

We are planning to establish our own lab.

 

What are the requirements that I need to consider?

 

Thank you.



#2 FSQA

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Posted 15 January 2019 - 07:26 PM

Hi.

 

We are planning to establish our own lab.

 

What are the requirements that I need to consider?

 

Thank you.

Hi,

 

Requirements can vary from the type of products, testing methods and equipment/chemicals that will be used in the lab.

 

However, following are just few of the considerations that you should look into:

  • Type of Lab (chemical/biological)?
  • Equipment and instrumentation to be used?
  • Calibration of equipment?
  • Test Methods and validity of the test?
  • Segregation of the lab from direct access/opening to the production site?
  • Employees professional ability to perform testing in the lab?

It is always a good idea to have written test methods and other procedures under a GLP (good lab practices ) Policy.


Edited by FSQA, 15 January 2019 - 07:26 PM.


#3 Scampi

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Posted 15 January 2019 - 08:10 PM

Depending on what your lab will be doing you may need to become accredited as well.

 

Lab equipment is VERY expensive and you may want to include an exhausted cabinet, so the lab would need to be located in an area where the hood could easily be vented outside

 

You'll also need lab furniture (cabinets and counters), plate readers, autoclave, incubators

 

Depending on annual cost of using an outside lab, you may very well find it's not worth having  (cost benefit analysis here)

 

The lab needs to be segregated AND capable of being locked

 

At the very least for salmonella and ecoli you'll need buffering solutions and swabs and petri dishes and a plate reader (unless you want to manually count colonies)


Because we always have is never an appropriate response!


#4 solrac

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Posted 15 January 2019 - 10:55 PM

Thank you so much for all your inputs.

 

We are planning to establish a micro lab: pathogen testing, TPC, molds and yeast and coliform using petrifilms

 

Thank you.



#5 Charles.C

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Posted 16 January 2019 - 01:29 AM

Nobody mentioned the handling of the waste material. It's not that simple.

 

Afaik, the risk (fear?) of cross-contamination has resulted in many companies in USA avoiding in house micro.laboratories.


Kind Regards,

 

Charles.C


#6 012117

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Posted 16 January 2019 - 03:02 AM

On top of what was mentioned above you need to also consider the following especially if your handling pathogen (Salmonella).

 

Flow of air. While not really an "air-borne", you want to avoid that your pathogen lab will contaminate your entire lab through air circulation of people flow. Normally HEPA filter is applied for air handling units for pathogen lab.

 

Decontamination room.

 

Media prep room and washing area separated from analysis room.

 

Depending on your sample, you may also invest in "stomacher".

 

Given that you will analyze for different parameters, you will need different incubators with different settings.

 

Refrigerators for your petri films and/or other media.

 

Large quantity of nalgene bottles.

 

On top of this, you will also invest in chemical storage area (to include safety) and flow for sample reception/waste disposal.

 

AS Scampi said, perform cost analysis especially if you dont have so many samples to begin with.



#7 trubertq

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Posted 16 January 2019 - 04:00 PM

Don't.

As a former manager of a Independent Laboratory the costs of equipping and maintaining a testing labortaory is prohibitive.

 

Plus the fact that it is preferred that pathogen analysis is performed off site to avoid risk of contaminating the production facilities with pathogens.

 

You need to employ trained personnel who won't come cheap. it's 7 days a week 52 weeks of the year, so you need staff to cover that.

 

I ran the lab on my own for the first year I never got a day off, it was not fun, or a good idea. 

 

 

I bet when you compare the cost of external analysis to that of setting up and running an internal lab the former will be the better value.


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

#8 MsMars

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Posted 16 January 2019 - 04:42 PM

Don't.

As a former manager of a Independent Laboratory the costs of equipping and maintaining a testing labortaory is prohibitive.

 

Plus the fact that it is preferred that pathogen analysis is performed off site to avoid risk of contaminating the production facilities with pathogens.

 

You need to employ trained personnel who won't come cheap. it's 7 days a week 52 weeks of the year, so you need staff to cover that.

 

I ran the lab on my own for the first year I never got a day off, it was not fun, or a good idea. 

 

 

I bet when you compare the cost of external analysis to that of setting up and running an internal lab the former will be the better value.

 

This. 

 

If you plan on doing anything more complicated than APC & coliform Petrifilm analysis, it gets tricky. WIth pathogen testing (even Petrifilm analysis) you'll want the lab to be off-site or out of the production facility. Growing pathogens in the same building you are trying to eradicate them from is a high-risk activity.  Consider what others have mentioned about personnel, training, equipment, etc. and make sure you conduct an accurate cost/benefit analysis.  I've only seen these in-house production facility labs make sense for large corporations with established regional laboratories that provide support to the production labs. 



#9 rain9878

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Posted 16 January 2019 - 05:06 PM

Is there a risk of contamination if we use test kits like hygiene test kits?



#10 Scampi

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Posted 16 January 2019 - 05:41 PM

you mean to contaminating your facility?

 

Is there a risk of contamination if we use test kits like hygiene test kits?


Because we always have is never an appropriate response!


#11 MsMars

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Posted 16 January 2019 - 07:14 PM

If the tests don't involve actually culturing pathogens, then no.



#12 rain9878

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Posted 16 January 2019 - 07:19 PM

We use test kits like this. https://www.hygiena....otal-other.html

 

There is an enrichment step but there shouldn't be a risk for contamination right?

 

you mean to contaminating your facility?

 

 

If the tests don't involve actually culturing pathogens, then no.



#13 MsMars

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Posted 16 January 2019 - 07:32 PM

We use test kits like this. https://www.hygiena....otal-other.html

 

There is an enrichment step but there shouldn't be a risk for contamination right?

 

Theoretically there is always a risk when you are culturing anything.  However, you aren't culturing specific pathogenic organisms and this looks to be a closed system, so as long as you keep preparations contained in your laboratory and dispose of the used tests properly, you should be OK.  Someone who's used these in the past correct me if I'm wrong, but I think these would be similar to the risk of using Petrifilm. 

 

Usually the biggest risk of testing for specific pathogens in a laboratory is related to the need to keep confirmation cultures. 



#14 Scampi

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Posted 16 January 2019 - 07:32 PM

We use test kits like this. https://www.hygiena....otal-other.html

 

There is an enrichment step but there shouldn't be a risk for contamination right?

 

You are correct. You aren't culturing anything....your simply testing for what might already exist.


Because we always have is never an appropriate response!


#15 Charles.C

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Posted 16 January 2019 - 08:15 PM

You are correct. You aren't culturing anything....your simply testing for what might already exist.

 

Enrichment = multiplication of bacteria = culturing


Kind Regards,

 

Charles.C


#16 Scampi

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Posted 16 January 2019 - 08:27 PM

My mistake..............i should have read further...............at first glance that swab kit looks like a swab and read, but it isn't, the samples need diluted and plated


Because we always have is never an appropriate response!


#17 Danica

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Posted 16 January 2019 - 09:08 PM

Also, if you are not affiliated with academics..things will get VERY expensive VERY fast as you will not have institutional discounts from suppliers. I used to work in research labs and costs are more than 40% higher for 'non-academic-affiliated' customers.

 

And the permits to operate a BSLII lab, including equipment that goes with it...inspections, etc. I highly doubt that your testing cost with an ISO 17025 lab will equal the investments for a lab.

 

In any case, best of luck to you!

Kindest Regards

Danica



#18 liberator

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Posted 16 January 2019 - 09:33 PM

To add to the discussion (also ex lab manager here) - we never did any pathogen testing on site - just the usual TPC, yeasts, moulds, coliforms etc. Pathogen analysis is very exact and really should be left to the experts. Always at risk if there is no critical hygiene controls in place that cross contamination could occur. As soon as you start to prepare samples and incubate you are growing up potential pathogens from low counts to huge numbers which are required to enable detecting by the test methods. This increases your risk. You also need to hold live pathogen cultures which are used as a control set to confirm your pathogen tests are working correctly.

 

Do you need to be certified to an ISO (17025) standard or are you using your results for in-house only, not for product release? If for product release then you have to have validation and verification processes in place to ensure your can "trust" the results being produced.(You need this for in-house as well.) If you are releasing/clearing product based on your results you have to be confident they are correct. There would be nothing worse than clearing product only to have a recall because it was positive for the exact pathogens your cleared the product on.

As you looking at micro testing then you will need to do some media preparation - unless you buy in pre prepared plates (eg petrifilm et.al) you will still need a diluent. This can also be bought in pre prepared but preparing in house can be cost effective. however you will still need a lot of equipment at a minimum you'll need: scales - to weigh to the samples and prepare the dilutions.  Stomacher for preparing the samples. Blender bags (for use in the stomacher). Pipettors - micro for preparing serial dilutions. Sterile pipettes, pipette tips, plate count reader (to read the results) - auto ones are available for Petrifilm. Manual ones with lit base and magnifying glass to aid in reading the plates, incubators ( how many will depend on the tests being performed and the temperatures required typically 30°, 37° 55° C,) water baths (to maintain the diluents/agars temperature), test tubes, test tube racks, test tube caps, media bottles and caps, refrigerator and above all an autoclave.

As trubertq, noted you will need trained staff - absolutely critical for pathogen testing.

 

As Charles commented: You would also need to check your state/country prescribe waste disposal regulations - micro waste can be classified as "prescribed medical waste" and this needs special waste collection and can't be just dumped into the usual waste stream.

 

Above all one of the biggest and most expensive piece of equipment you'll need will be an autoclave. This is needed to sterilize your media, to sterilise the used test plates, diluents etc and waste, lots of waste. You can get small bench top models but if you're serious go large, small never works.

 

It may well be worth a vist to an established food testig lab to see



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