Microbial Standard for Bacteria, Fungus & Mold for Equipment

S

sidmishra - 2008

#1
hi

can anybody tell me about the microbial standard for bacterias, fungis & molds for the equipments used in a personal care manufacturing unit?
 
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J

Jimmy the Brit

#2
Re: microbial standard

hi

can anybody tell me about the microbial standard for bacterias, fungis & molds for the equipments used in a personal care manufacturing unit?
Hi Sidmishra,

It depends what equipment you are talking about: If you mean manufacturing equipment/environment then ISO14644-1 sets the limits for non-viable particulate levels based on the room classification. USP states the suggested microbial limits for pharmaceutical manufacturing facilities based on the room classification in General Chapter 1116 and for the EU Eudralex Volume 4 Annex 1 does the same. These limits apply to process equipment as well (surface count limits)

The different references use different classification names/numbers, but if you reconcile the particulate limits you can work out which is which easy enough.

I don't know of any specific microbial limits for medical device manufacturing, but the limits in USP and Eudralex for class 10,000 and 100,000 rooms are generous and I believe easy to meet in a well designed cleanroom.

If you mean the actual bioburden on items for sterilization then that is set by your sterility assurance program and validated sterility assurance level.

Let me know if I have misunderstood your question,

Jimmy
 

YellowQCPro

Starting to get Involved
#4
This post most resembles the forum to post my question, please let me know if there is another place!! Anyways, I just received my lab report for bioburden. The results is "samples with "<" numbers indicate 0 cfu were recovered". Now, it's hard to believe that products sent non-sterile to the lab, actually came back with 0 bioburden???? Does this mean that we are producing sterile devices, and there is no need to sterilize? Does this mean that we can state non-pyrogenic? we are validating our sterilzation cycle with PCD's, so i don't think that this result will damage the validation, just wondering how to interpret the information. Thank you in advance for your help!
 

Ajit Basrur

Staff member
Admin
#5
This post most resembles the forum to post my question, please let me know if there is another place!! Anyways, I just received my lab report for bioburden. The results is "samples with "<" numbers indicate 0 cfu were recovered". Now, it's hard to believe that products sent non-sterile to the lab, actually came back with 0 bioburden???? Does this mean that we are producing sterile devices, and there is no need to sterilize? Does this mean that we can state non-pyrogenic? we are validating our sterilzation cycle with PCD's, so i don't think that this result will damage the validation, just wondering how to interpret the information. Thank you in advance for your help!
Just because the device has 0 cfu does not indicate it could be always sterile. 0 cfu could be due to multiple reasons - the main being, the material being inert does not give chance for bacteria and others to grow.

If the device is intended to be sterile, it should be sterilized through one of the known sterilization methods. Therefore, even if your device has 0 cfu, you can not be sure of those results "consistently".

You should also remember that even if an article is intended to be sterile, the bioburden prior to sterilization should be low enough to assure a Sterility Assurance Level (SAL) based on the criticality of the device.
 
M

MIREGMGR

#6
Another way to get an apparent 0 CFU datum--not likely your problem, but worth mentioning so that you can rule it out--is to have a tested material turn out to be non-biocompatible, and in fact sufficiently toxic (or using other language, anti-microbial) that it cannot be evaluated using normal methods.

Materials containing silver or copper at their surface, or sometimes other metals, will do this at times even if not designed to do so. So might a material that contains significant levels of certain other elements, or of course intentionally antimicrobial additives.

So, less favorably, can materials containing certain flame retardants, heat stabilizers, preservatives and flexibilizers.
 

Ajit Basrur

Staff member
Admin
#7
You are absolutely right - sometimes, the microbiological media may inhibit growth and thus the analytical method needs to be validated for Recovery Test.
This is a prerequisite for carrying out the microbiological testing.
 
S

siju234

#8
Dear Sir,

I request your help regarding total plate counts in Bottled water:

Occasionally, I am getting a Total plate counts bacteria of more than 300 cfu/ml from our Bottled mineral water. As per specification the maximum limit is 25cfu/ml. Because of this problem a huge quanity of finished products have been rejected and destroyed. Whether the bottled water with high total plate counts consumption will cause any serious harm to the consumer? What are the main bacteria used to present in total plate count ? Can you please name some examples for plate count bacteria?
 

Ajit Basrur

Staff member
Admin
#9
Dear Sir,

I request your help regarding total plate counts in Bottled water:

Occasionally, I am getting a Total plate counts bacteria of more than 300 cfu/ml from our Bottled mineral water. As per specification the maximum limit is 25cfu/ml. Because of this problem a huge quanity of finished products have been rejected and destroyed. Whether the bottled water with high total plate counts consumption will cause any serious harm to the consumer? What are the main bacteria used to present in total plate count ? Can you please name some examples for plate count bacteria?
Pls give more details on your water generation system and your past investigation done subsequent to high bacterial counts.
 
S

siju234

#10
Our plant is equippped with Reverse Osmosis Filter system, located in Saudi Arabia..The source water in this area contains high amount of bromide ions result of that high amount of bromate contents in product water, because of that we are treating our product water with very less quantity of Ozone (0.03mg/l). If we increase Ozone that leads to the formation of Bromate in Product water ,so we need to maintain ozone lessthan 0.03mg/l. Our factory is already warned by the Health department for the high amount of Bromate in product water in the past, So we are not in a position to increase the ozone quantity . I have found that this ozone quantity is enough to get rid off the bacteria but not 100 % , I meant occasionally we are getting high aerobic microbial counts. Usually we are getting 1 or 2 aerobic counts only (from the pour plate method).
 
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