Case study: Upgrade of an existing sterile production room of freeze-dried vaccines to comply with the requirements of the new GMP annex 1
A B S T R A C T
Many pharmaceutical companies have Freeze Dryers in their plants with manual loading and unloading procedures. For most cases, they are using old but reliable equipment. This means that the loading of the containers from the filling line to the freeze dryer and the unloading from the freeze dryer to the capping machine is done manually in an ISO 5 clean room with the main door of the lyophilizer open and with trays containing the primary containers (normally vials or ampoules). With the expected new release of GMP Annex 1, there is an increasing need to upgrade these processes to guaranty the strictest conditions in all operating phases inside the sterile rooms. Instead of relying on the clean room classification, the use of passive or active laminar airflow trolleys together with RABS (restricted area barrier systems) for the movement of the trays with the product containers, avoids product exposure to operators and reduces the operator’s movements. Still the interface with these loading devices and the lyophilizer shelves through a full open door is a potential issue. The solution set out below has helped to ensure that from the outlet of the filling line to the freeze dryer loading/unlading door and from there to the capping machine, the vial trays are always inside an open RABs with particle contamination control and never in contact with the production operators.
Parenteral Product Manufacturer
The pharmaceutical company, a European vaccine producer, currently had one LYOMEGA LM100-ST Freeze Dryer installed in 1995 with a big main door opening into the clean room, served by a filling machine and a capping machine in the same classified ISO5 room.
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