Is there possible to run filling activity under LAF with background of garde c area?
No, LAF must be placed in class B area.
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Can we Reuse seal which falls Around Seal m/c but under LAF while sealing operation when we have shortage Qty .
As per cGMP you should not use sterilized fallen seals.
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.
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No, the seals fallen around the machine can’t be used.
Quoted from WHO Annex 6:
“4.18 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.”
“4.13 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.”