ISO 11737 - Bioburden testing for non-sterile products

C

Cec28007

#1
What type of microbial testing is required for non-sterile product containers before filling? I have not found any regs. that require testing for incoming containers. Does anyone do any microbial testing on their non-sterile product containers? We are planning on following the ISO 11737 for bioburden and then simply disregarding the information on sterility, since our products are not claiming sterility. This will give us a good indication of what microbial load our containers are coming in with, then we just monitor as we would any environmental monitoring. Any input is appreciated.


Clint Christensen
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Bioburden testing for non-sterile products

Out of curiousity, what product type are you making?

I have not found any regs. that require testing for incoming containers.
I don't know of any such regs either, but my focus is primarily medical devices for which the sterile/non-sterile regulatory division is rather absolute.

Does anyone do any microbial testing on their non-sterile product containers?
We don't. Non-sterile for us means that the product's intended use involves contact with normal unbroken skin at most, and that there is no expectation on the part of the clinical user or the patient of absence of typical environmental microorganisms on surfaces.
 
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C

Cec28007

#3
Re: Bioburden testing for non-sterile products

Out of curiousity, what product type are you making?
We manufacture a variety of dental products. Some of which include hemostats, bleaching gels, toothpastes and fluoride treatments. All intended for use in the oral cavity of course.
 
J

Jimmy the Brit

#4
Re: Bioburden testing for non-sterile products

We manufacture a variety of dental products. Some of which include hemostats, bleaching gels, toothpastes and fluoride treatments. All intended for use in the oral cavity of course.
Whoa - I had no idea hemostats were non-sterile - doesn't this fly in the face of the requirements of ANSI/AAMI ST67 Annex B? Even tongue depressors are expected to be supplied sterile, albeit with an SAL of just 10 x -3.

I speak from a position of no-knowledge of dental supply requirements, I am just surprised that a "device" that is required to have blood and mucosal contact as part of its function is not even required to have a bioburden limit.

Anyway, back to your original question, no I don't believe that there are limits for bioburden for non-sterile devices, other than those limits that you may choose to impose yourself to demonstrate control of process. Bioburden is really only useful to ascertain the magnitude and resistance of the challenge to the sterilization process.

Since toothpastes, gels and treatments are quite close to pharmaceutical oral dosage forms you could always use the USP2007 limits defined in section <1111> Microbiological Examination of Non-Sterile Products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use. Table 1 states a limit of 100 cfu/ml total aerobic microbial count and 10 cfu/ml for yeasts & moulds (combined). It also includes a test for two objectionable microorganisms in that dosage form Staph. aureus and Pseudomonas aeruginosa - pathogens which have the potential for human infection - easy enough to exclude from the process, but by monitoring you can protect yourself from legal claims from patients/dentists trying to pass the responsibility.

Not sure if this helps at all, or if I have just made your world much more complicated than it needs to be,

Jimmy
 
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Ajit Basrur

Staff member
Admin
#5
Re: Bioburden testing for non-sterile products - ISO 11737

What type of microbial testing is required for non-sterile product containers before filling? I have not found any regs. that require testing for incoming containers. Does anyone do any microbial testing on their non-sterile product containers? We are planning on following the ISO 11737 for bioburden and then simply disregarding the information on sterility, since our products are not claiming sterility. This will give us a good indication of what microbial load our containers are coming in with, then we just monitor as we would any environmental monitoring. Any input is appreciated.

Clint Christensen
Welcome to the Cove, Clint :bigwave:

Jimmy has given great advise. To add on, some of the guidleines that have mentioned about the Bioburden in dental devices are -

Guidelines for Infection Control in Dental Health-Care Settings - 2003

Additonal info also available at Infection Control in Dental Settings

Hope this is useful to you - should you have more queries, pl revert back :)
 

6thsense

Involved In Discussions
#7
well I work for a beverage making concern and The owners of the company have a requirement for Bioburden analysis of Bottles and Closures. the procedure is really good and i strongly recommend that u do it.
 
C

Cec28007

#8
well I work for a beverage making concern and The owners of the company have a requirement for Bioburden analysis of Bottles and Closures. the procedure is really good and i strongly recommend that u do it.
I would be interested to know what procedures you follow. Are you rinsing the interior of the bottle with an extraction solvet? How do you validate the testing? Any more information on the testing procedure you use would be helpful. Thanks!!
 

6thsense

Involved In Discussions
#9
The Bioburden Method

Preparing the extraction fluid

Requirements are:
1 ml Tween 80 (polysorbate 80)
1 ltre deionized water
2.5g peptone

Place all the above in an Autoclavable Flask (can use aluminium foil/cap to close the the top of the flask) and Autoclave the flask at 121 degrees celcius for 15mins.

When you have the Extraction fluid you can proceed. for the bottles we approximate 50ml of extraction fluid/bottle that you pour inside the bottle and swirl. then membrane filteration to plate the sample:
;)
 
E

eeckler

#10
Re: Bioburden testing for non-sterile products

Whoa - I had no idea hemostats were non-sterile - doesn't this fly in the face of the requirements of ANSI/AAMI ST67 Annex B? Even tongue depressors are expected to be supplied sterile, albeit with an SAL of just 10 x -3.

I speak from a position of no-knowledge of dental supply requirements, I am just surprised that a "device" that is required to have blood and mucosal contact as part of its function is not even required to have a bioburden limit.

Anyway, back to your original question, no I don't believe that there are limits for bioburden for non-sterile devices, other than those limits that you may choose to impose yourself to demonstrate control of process. Bioburden is really only useful to ascertain the magnitude and resistance of the challenge to the sterilization process.

Since toothpastes, gels and treatments are quite close to pharmaceutical oral dosage forms you could always use the USP2007 limits defined in section <1111> Microbiological Examination of Non-Sterile Products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use. Table 1 states a limit of 100 cfu/ml total aerobic microbial count and 10 cfu/ml for yeasts & moulds (combined). It also includes a test for two objectionable microorganisms in that dosage form Staph. aureus and Pseudomonas aeruginosa - pathogens which have the potential for human infection - easy enough to exclude from the process, but by monitoring you can protect yourself from legal claims from patients/dentists trying to pass the responsibility.

Not sure if this helps at all, or if I have just made your world much more complicated than it needs to be,

Jimmy
I've been very interested in this area myself. We'll be manufacturing a single-use disposable with vaginal mucosal contact. It has been our read of AAMI ST67 that it applied only to devices claiming sterility, not as a supply mandate. Most vaginal specula are sold clean, non-sterile. I have been looking for cleanliness standards/allowable microbial count similar to the USP standards for drugs,but for nonsterile medical devices.
 
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