RLAF/LAF pre conditioning before execution of Sampling Activity

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Please refer/guide me any regulatory document for starting of RLAF/LAF prior to sampling/Dispensing in an OSD facility.

Presently we have mentioned in our SOP that booth shall be started prior to 15 minutes of sampling/Dispensing
activity to maintain the required class in the booth.

Is it right or wrong ? and what should be the exact time for an OSD facility ??

please also give any reference guideline or any SOP for the same.

Thanks
Parveen Garg

2

Please refer/guide me any regulatory document for starting of RLAF/LAF prior to sampling/Dispensing in an OSD facility.

Presently we have mentioned in our SOP that booth shall be started prior to 15 minutes of sampling/Dispensing
activity to maintain the required class in the booth.

Is it right or wrong ? and what should be the exact time for an OSD facility ??

please also give any reference guideline or any SOP for the same.

Thanks
Parveen Garg

3

Anyone please guide me. And give me some reference,if you have.

Parveen

4

[quote=parveen.garg]Please refer/guide me any regulatory document for starting of RLAF/LAF prior to sampling/Dispensing in an OSD facility.

Presently we have mentioned in our SOP that booth shall be started prior to 15 minutes of sampling/Dispensing
activity to maintain the required class in the booth.

Is it right or wrong ? and what should be the exact time for an OSD facility ??

please also give any reference guideline or any SOP for the same.

Thanks
Parveen Garg[/quote]

Hi Parveen

There is no such stipulated time / duration mentioned in any of the regulatory documents and it should be based on the recovery study performed for that particular RLAF/LAF unit.

Shankar Narayan

5

Hi Praveen,
The time the LAF is started prior to use should be based on the recovery time for the area beneath the LAF to achieve it’s required classification.
Regards

6

thanks dear,

But please guide, if my recovery study is 12 min. Is it possible to hav the start up time upto 30 minutes.

Thanks
Parveen garg