Page 21 - Laboratory manual for students FAR222 2019 20

FAR 222 Dosage Form II Laboratory Manual

vii. Filling and sealing

Only clarified formulation is transferred to a final container except for aseptic filtration as
sterilisation method. The type of container available in the School’s Compounding Laboratory
is shown in Table 8. The filling process can be done in two ways, either using a measuring
equipment or filling directly to a final container. Topping up to the final volume in a final
container can happen if the container is pre-calibrated. It is highly recommended to rinse the
measuring equipment and the final container with some parts of the clarified formulation.
The types and treatment to the container or closure should be specified. For instance, rubber
closure for injection can absorb a significant amount of preservatives and antioxidants. The
rubber closure should be soaked overnight with a solution with twice the strength of the
preservatives and/or a similar strength (or recommended strength) of antioxidant.
The container is sealed accordingly with a proper closure.

Table 8 Type of container available in the School’s Compounding Laboratory

Type of Volume of
formulation Container Closure container (mL)
Amber glass eye Glass dropper with
Eye drops 30
drops bottle rubber teat
Amber/clear glass
Eye lotion Plastic cap 50, 100, 200
bottle
Multiple dose Clear multiple dose Rubber closure and 20
injection glass vial metal cap
Amber glass ampoule
Ampoule - 1, 2, 5
vial
Intravenous Clear glass infusion Rubber closure and
infusion vial metal cap 500

viii. Sterilisation

Sterilisation method is usually stated in monograph. Otherwise, a compatible sterilisation
method should be used based on the properties of the ingredients. The condition of the chosen
sterilisation method should be detailed. Leak test for ampoules is usually conducted together
with sterilisation.

ix. Labelling

Product is to be labelled after sterilisation. Products should be allowed to cool to room
temperature prior to labelling if sterilisation involves heat.

19