Grade D Laboratory Environment Airlock Requirements

[maryacton]

I was just wondering if you knew if to achieve a Grade D laboratory environment 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?

Not sure if I posted in the correct thread but would really apprecaite some hekp or guidance as to where I can source the information.

Thank you

 

[harry]

I was just wondering if you knew if to achieve a Grade D laboratory environment 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?

Not sure if I posted in the correct thread but would really apprecaite some hekp or guidance as to where I can source the information.

Thank you

Hi Mary,

I am not sure if this is what you want....

Pharmaceutical Cleanroom Classification

The most recent set of standards for Europe has come into operation on the 1 January 1997. This is contained in a 'Revision of the Annexe to the EU Guide to Good Manufacturing Practice-Manufacture of Sterile Medicinal Products'.

The following is an extract of the information in the standard that is relevant to the design of cleanrooms:

'General

The manufacture of sterile products should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency.

The various operations of component preparation, product preparation and filling should be carried out in separate areas within the clean area. Manufacturing operations are divided into two categories; firstly those where the product is terminally sterilised, and secondly those which are conducted aseptically at some or all stages...........

More info from this link - CLASSIFICATION OF CLEANROOMS AND CLEANROOM STANDARDS

 

[maryacton]

Thanks Harry for your response and the great information,

From what I can see there is no special requirement that you need an air lock to achieve a Grade D compliant laboratory as long as you conform with the airborne standards.

Thanks again Harry

 

[Ajit Basrur]

I was just wondering if you knew if to achieve a Grade D laboratory environment 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?

Not sure if I posted in the correct thread but would really apprecaite some hekp or guidance as to where I can source the information.

Thank you

Hi Maryacton,

You are probably referring to ISO Class 8 clean rooms (equivalent to Grade D or Class 100,000).

I would strongly recommend an air lock to the clean room. Also if you are handling laboratory chemicals, do take a look at the pressure differentials between the rooms.