What is the most appropriate Bioburden Test Method for Surgical Gloves

C

Chithra86

#1
Hi, i would like to know what is the most appropriate method for determining bioburden for powder free surgical glove? Currently we are using the enumeration method, and would like to switch to the membrane filtration method, but during the filtration, media used (DE), is unable to pass through the filter. Its taking ages for the media to be filtered. We stomach the glove pcs, with DE (100ml), and passed through the filter, but this seems not to be working. I would appreciate any feedback or suggestion to validate the new bioburden method.
 
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Ajit Basrur

Staff member
Admin
#2
C

Chithra86

#3
Hi, i am looking for the non-sterile bioburden method. The glove samples are non sterile and its for normal routine monitoring purpose.
 
C

Chithra86

#5
This method is not working, as when we tried the gloves got stuck in the blender and the blades are not moing. I think any gloves will stick to it. I am really helpless on what can be done here.
 

rangani_rj

Involved In Discussions
#7
Hi,

Generally, you should not use media for removing bacteria from gloves. Media is generally thick and it will never pass through 0.3 micron membrane filter.

Instead, generally, as what we do in Pharma, use sterile water (may be WFI) with surfactant (which have no bacteriostatic action) to remove bacteria, filter it and culture the membrane in plate.

The best method is direct culturing, in your case you can cut the glove in pieces and culture it, make sure both surfaces get exposed to media.

You can refer below standard which is particularly designed for medical device, gives good idea about sterility testing

Sterilization of health care products?Microbiological methods?Part 1: Determination of the population of microorganisms on product

Annex A of this standard gives general idea about methods to be used according to types of medical device (liquid, solid, foam, powder etc.)

Also go through Annex B - "B.2.2 Removal techniques" (for microorganism)
Stomaching
Ultrasonication
Shaking (mechanical or manual)
Vortex mixing
Flushing
Blending (disintegration)
Swabbing
Eluents, diluents, and transport media

Another thing - you have to use gentle mixing process (magnetic stirrer/ shaker) - not that high speed mixer.

In my opinion - mechanical shaking/sonification/vortex/flushing are good option.

Whatever you use, make sure it is reproducible.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
You can refer below standard which is particularly designed for medical device, gives good idea about sterility testing

Sterilization of health care products?Microbiological methods?Part 1: Determination of the population of microorganisms on product
It is ISO 11737-1.
 
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