Our manufacturing site was recently upgraded and includes the following:
A class 10,000 unit (Grade C) for oral liquid production
Two class 10,000 cleanrooms (Grade C) for the filling of parenteral products
Vial Wash Room
Bottles/Vials are washed in a dedicated Class 100,000 Room using purified water (WFI) and then dried with filtered air. The vial wash machine has the capability to wash glass vials ranging in size from 10mls to 500mls.
After raw materials have been QC approved/released, they are weighted out and packaged in an environmentally controlled area – the Dispensary. Each employee exercises the exact safety protection measures to handle and weigh materials as specified by their individual MSDS’s.
Subsequent to Raw Materials being dispensed, they are then transferred through the Relevant Materials Entry to the Bulking Room. Once bulked, an in-process sample is then approved by Q.C. Laboratory.
Suite 1 – Oral production Suite
Filling of oral products occurs in the Class 10,000 Filling Room of Suite 1, using suitable filling equipment. Pack sizes currently vary from 100mls to 1000L IBC’s.
Suites 2 & 3 Injection suites
Parenteral products are filled, bunged and capped under Laminar Airflow Units within Class 10,000 rooms. Vials are either glass or plastic and range in size from 10ml to 500ml.
Injectable products are terminally sterilised under specific conditions using an SBM Vakutherm air/steam steriliser. This is located in a dedicated class 100,000 room.
Product is visually inspected, labelled and packaged in the labelling hall. The labelling machine is used to overprint batch number and expiry date onto labels and cartons of varying sizes.