Services
Filling
Filling area is separated into three independent filling lines. The first line is tube filler one, the second line is tube filler two and the third line is the bottle/jar filler.
Product can be transferred from formulation suite one and filled either on tube filler one or on the third filling line jar/ bottle filler depending on presentation.
Secondly, product can be transferred from formulation suite two and filled on either tube filler two or on the third filling line jar/ bottle filler.
The third formulation suite does not have a transfer line; the product is transferred manually into the vats located on top of the filling machines.
All tubes/ jars/ bottles are unscrambled from cardboard boxes in the transfer airlock into polypropylene boxes prior to filling.
No cardboard boxes are transferred into the filling rooms.
All products in the filling rooms are sealed and capped prior to transferring into the packing room.
Packing
Packing area has three segregated area, as the product can be transferred via conveyor belts to packing station one, two or three.
The product can be labelled and cartoned as individual units or can be shrink wrap in accordance to requirements.
Expiry dates/ Date of manufacture/batch number can be printed on the product for identification via a jet-printer.
Quality Systems
Quality system is in place incorporating SOP/ Support documents/ Word Instruction/ Validation Protocols/ training matrix.
The organization has a site master file which identifies its operational systems.
All equipment has undergone Operational/ Instrumental/ Process Qualification (OQ/ IQ/ PQ).
All mixing/filling processes are validated in accordance to requirements for AUSTL and AUSTR products; similarly, cleaning processes are validated as required.
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