Grade D Laboratory Environment

GOOD LABORATORY PRACTICE (cGLP)
1

Hi Guys

I was just wondering if anyone knew if to achieve a Grade D laboratory environment if an air lock is required?

We had our air tested, however we were wondering if that is enough and does it matter how grade D is achieved?

Any guidance would be greatly appreciated

Regards

2

[quote=gokeeffe]Hi Guys

I was just wondering if anyone knew if to achieve a Grade D laboratory environment if an air lock is required?

We had our air tested, however we were wondering if that is enough and does it matter how grade D is achieved?

Any guidance would be greatly appreciated

Regards[/quote]

The entry in Grade D area should be through airlocks/ buffer for personnel, equipment and materials.The Grade D area should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency. Proper air flow pattern must be designed and complies.

Thanks

3

Hi Shahnawaz

Thanks for the reply, I take it so that without an airlock a laboratory

cannot achieve a grade D status?

Regards

4

[quote=gokeeffe]Hi Shahnawaz

Thanks for the reply, I take it so that without an airlock a laboratory

cannot achieve a grade D status?

Regards[/quote]

Dear Gokeeffe,
Most prefebly air lock must be present as a bearrier between two different areas/classes. or clean and unclean zone, if air lock are not present or not designed then at least maximum air changes are required at the entry of Grade D area which may segregate the two areas with positive differientail pressure.

Thanks

5

Thank you Sir

6

Dear Gokeeffe,

An air lock must be present at the entrance of a grade D lab which should be bubble type airlock in which air comes out from the air lock in both direction with the pressure differential of 5 - 20 Pa range.

The filtration efficiency should be minimum F9 according to filter grades EN 779 /EU 9 according to filter grade DIN 24185 part2 .

Thanks

7

Many thanks