Dear All,
Can any body clarify,
in the dispensing area for OSD (Oral SOlid Dosage i.e. Tablets), it is better to have bubble type air locks or cascade type ?
Will it be acceptable to do some operation like dedusting of material containers in the air lock before they are taken out to the clean corridor ?
Regards…
Ajay
In cascade air lock there will be effective movement of air and praticulate matter in one direction. In this case either movement of air from adjescent corridor into dispensing zone or Dispening zone towards corridor is not accepted by GMP.
A Bubble air lock will be good for such operation. Suppose you have 15pa in corridor and 15pa in your dispensing area you should have a Bubble airlock with 30pa pressure. This prevents the dust from either way to enter into respective areas.
corridor 15pa <----- 30pa-----> 15pa Dispensing zone (its an Ideal situation)
I do not think airlocks are used for dedusting procedures. If you want an airlock for such purpose you have to build a SINK AIR LOCK.
30pa-----> 15pa Sink airlock<------- 30pa
Regards
Thanks…
Is it acceptable if additional gowning is to be done in the bubble type airlock before entering into the dispensing room and degowning to be done while coming out from the dispensing room ??
Regards,
Ajay
My reply on Gowning Airlocks is NO.
I meant only for material movement.
Materials must enter an airlock different from man power.
Its a different flow.
For men to enter into airlocks you need cascade system.
Where High pressure flows from the cleaner area towards Non-Classified areas.
When we talk about Dedusting or any material handling , Bubble airlock or Sink airlocks are acceptable.
One side men enter the Dispensing rooms and exactly 90 degree to them the material exit out.
You must programme that way.
You can make it better by drawing your men movement on paper first with Blue ink.
Then put your material movement on the same paper with a green ink.
Make sure they never criss cross or come back.
Regards