I am in the process to establish the EMPQ protocol for sterile ophthalmic manufacturing facility. This facility have aseptic filling operation in Three Piece Bottles i.e. presterile bottles, droppers and caps.
Core filling zone is Open Restricted Access Barrier (ORAB) having unidirectional air flow which provides the Grade A environment. ORAB is surrounded by Grade B area (Filling Room)
Other adjacent rooms are Aseptic corridor, cooling room, sterile PPM storage , Filtration room.
Typically my query is related to defining the LAF/UDF unit installed in Cooling room -
This unit provides the unidirectional air flow. Cooling room is used to unload the sterlized (by steam sterilizer) articles (we are using double door steam sterilizer). This LAF unit provides the protection to the sterlized articles while unloading.
To unload, an operator with sterilized clean room gowning need to intervene with whole body under this LAF unit and than sterilized articles are loaded in Mobile LAF for further transportation to the Filling suit.
Earlier the concept was to classify this LAF unit as Grade A since our thought process is to provide the Grade A environment to the sterilized articles at the time of unloading hence to ensure the sterility assurance.
Discussion point is the impact of human intervention occurring in this LAF unit.
An operator although having sterilized clean room gowning is moving inside this Unit after travelling through Grade B change room, Grade B corridor and than Grade B Cooling room. This is ceiling mounted LAF unit where there is only barrier is curtain.
What should be the classification of this unit ?
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