Filling activity in grade c

(jegan) #1

Is there possible to run filling activity under LAF with background of garde c area?

(Ankur Choudhary) #2

No, LAF must be placed in class B area.


Can we Reuse seal which falls Around Seal m/c but under LAF while sealing operation when we have shortage Qty .

(Manoj Singh) #4

As per cGMP you should not use sterilized fallen seals.

(Anil Khule) #5

Terminally sterilized products can be filled under LF with class C background area.
But aseptically filled products cannot be filled under LF with class C background.
It needs Class B surrounding area.

(Anil Khule) #6

No, the seals fallen around the machine can’t be used.

(Dr. Ahmed Mohamed Awad) #7

Quoted from WHO Annex 6:

β€œ4.18 The handling and filling of aseptically prepared products, as well as the handling of exposed sterile equipment, should be undertaken in a Grade A environment with a Grade B background.”

β€œ4.13 The filling of products for terminal sterilization should generally be done in at least a Grade C environment.
4.14 Where the product is at unusual risk of contamination from the environment (e.g. because the filling operation is slow, the containers are widenecked or are necessarily exposed for more than a few seconds before sealing), the filling should be done in a Grade A zone with at least a Grade C background.”