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Our manufacturing site is 1400 sq. metres in area and
contains three separate production units.
The recently
upgraded facility includes a class 100,000 unit for
oral liquid production and two class 10,000 cleanrooms
with class 100 Laminar Flow units. |
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| Materials Dispensary
All Raw Materials are dispensed
in a dedicated class 100 containment booth, within
a class 100,000 Dispensary Room. |
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| Vial Wash Room
Bottles/Vials are washed in a
dedicated Class 100,000 Room using the vial washing
machine. |
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Bulk Preparation
After the
Raw Material has been dispensed. The materials
are brought through the Relevant Materials Entry
to the Bulking Room. As appropriate - Class 100,000
room for oral products. Class 10,000 for parenteral
products. Post bulking an In-process sample is
approved by the Q.C. Laboratory |
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Suite 1
Filling Line Filling
of oral products occurs in the Class 100,000 Filling
Room of Suite 1, using an electronic 4 head Filling
machine. |
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Suites 2 & 3 Filling Lines
Parenteral products are filled, Bunged and capped
under Class 100 conditions.
This is achieved by
use of Laminar Airflow Units within Class 10,000
rooms. |
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Autoclave
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. |
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Labelling
Product is labelled and packaged in the labelling hall The labelling
machine is used to overprint batch number and expiry date onto labels
of varying sizes. All overprint is verified to be of good quality
during packaging. |
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