Why we select 0.5micron, 5 micron

GOOD VALIDATION PRACTICE (cGVP) HVAC VALIDATION
1

Dear all

  1. Our HEPA filter particle size 0.3micron, while during Particle count monitoring, why we are selected 0.5micron, and 5micron particles, as per ISO guidelines 0.1micron, 0.2micron, 0.3micron also available.

  2. Why we using 95% Upper confidence limit?

Please post any guidelines regarding this?

Regards
Sivakumar A

2

[quote=sivakumara]Dear all

  1. Our HEPA filter particle size 0.3micron, while during Particle count monitoring, why we are selected 0.5micron, and 5micron particles, as per ISO guidelines 0.1micron, 0.2micron, 0.3micron also available.

  2. Why we using 95% Upper confidence limit?

Please post any guidelines regarding this?

Regards
Sivakumar A[/quote]

Dear Mr.Siva Kumar

0.5 micron size particles are common in all classess, So that was taken as specification for all classess. Any other view from forum…

3

[quote=jyopravel]Dear Mr.Siva Kumar

0.5 micron size particles are common in all classess, So that was taken as specification for all classess. Any other view from forum…[/quote]

Dear Prasad sir

Even 0.1micron also common for all classes, so we can take 0.1micron?

regards//
Sivakumar
09894114092

4

This post is being repeated again and again.
I advice Mr.Sivakumar to refer IEST guidelines.
You company might be having them.
Its best guidance you can look.

5

Dear Mr.Prasad Sir,

Thanks for Guidance, Please if u have IETS guidelines please post it sir.

Regards//Sivakumar

6

You need to purchase them from their site.
I have no right to post or send in electronic mails.

7

Dear Mr. SivaKumar,
HEPA filters are meant/capable to retain 0.3 micron & above particle sizes.
As on today no any guideline other than ISO suggess to monitor 0.1 & 0.2 micron particle sizes.
why 0.5 & 5 micron?
we can perform monitoring for 0.1 & 0.2 micron particle sizes also no any guideline denies to perform but rational behind performing 0.5 micron is that, any micriorganism requires some medium/carrier to travel from one place to another & 0.5 micron is the minimum size require to travel any microb. Hence it is necessory to monitor 0.5 micron particles in classified areas. Moreover how many bigger sizes we should monitor ? there should be some limitations, hence 5 micron size is choosen.
Above all are my understandings tilll today.
If any budy realize that its wrong, then please comment.

regards,
Kishor D. Patawar

8

Bacteria generally range from a few microns to about 0.5 micron in size. It’s that simple. If you look at what the filters are filtering out, it’s pretty logical that you’d pick a pore size below that. Helps if you have some microbiology experience I guess.

9

generally hepa filters retain particles 0.3 microns and above the concept behind 0.5 and 5.0 micron is based on worst case and above gentlemens microbial concept is a fact

regards
benny