Hello there!
A) I wonder what it is the max allowed limit for glove 5 fingers test cfu/glove for microbial contamination in facility producing medical device products with ETO terminal sterilization. The ISO 13408 has not limit mentioned for grade D facility. How this test should not conducted ? based on what recommendations?
B) the standard recommend the time fro settle plates 4 hours. how we should consider how results if we made our tests for only one hour. has a linear just multiply by four or which else meaning?
Thanks for any clarifications
Eric:thanks:

Hello there!

A) I wonder what it is the max allowed limit for glove 5 fingers test cfu/glove for microbial contamination in facility producing medical device products with ETO terminal sterilization. The ISO 13408 has not limit mentioned for grade D facility. How this test should not conducted ? based on what recommendations?

B) the standard recommend the time fro settle plates 4 hours. how we should consider how results if we made our tests for only one hour. has a linear just multiply by four or which else meaning?
Thanks for any clarifications

Eric:thanks:

Hi Eric,

Answer A

By Grade D, I presume you are referring to ISO Class 8 (or Class 100,000) area, right ? I always prefer to refer to the United States Pharmacopeia (USP) section <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments.

If you refer to Table 5 in USP <1116>, it sets the following guidelines for the personnel gear (pl note these are only guides and expects the manufacturers to establish their own limit. But for all practical reasons, these are good enough) -

GLOVES CLOTHING and GARB

Class 100 3 5

Class 100,000 10 20

Theses tests are done by Contact Plate method where each of the contact plate area is between 24 cm and 30 cm square. If swabbing is used the total area covered should be between 24 and 30 square cm.

There is no mention of gloves monitoring / personnel garb monitoring for Class 100,000 (Class D) in European Pharmacopeia.

ANSWER B

Here again, I think you are referring to the 4 hour requirement under EU requirements, right ?

It doesnot mean that you should do a minimum exposure of 4 hours. Instead what it means is, the individual settle plates must be exposed for less than 4 hours.

I have attached EU Requirement - Annex 1 (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/pdfs-en/2008_02_12_gmp_annex1.pdf) for your information. Refer to Point 19 and Note (b) in that attachment.

Btw, do you perform volumetric air sampling like centrigual sampling ?

thanks you Ajit,
A) I 'm aware of these limits , I knew that for class 100000 no gloves or garments monitoring are requested ! but in fact we have been asked to measure and show and the results are not always like the limits that we are fixed, so lot on non conformance fro nothing had to be issued.
B) yes I m refered to the EU requirements, I m aware of this recommended publication. but the limits are mentioned for 4 hours so in facts if we did a measurement for only one hour what will be then the limits divide by 4?
This is not based on any other practice documents. the settles plates collection it is not linear function ? the products are assembly during all day long of production ( cardiology medical device terminal sterilization ).
C) we do not performed any other bio-test air sampling or volumetric .
Thanks you for your clarifications