Page 10 - Laboratory manual for students FAR222 2019 20

FAR 222 Dosage Form II Laboratory Manual

3 CONTAINERS, CLOSURES AND PACKAGING

The general requirements for containers for sterile products can be summarised as:
 chemically compatible with the product
 withstand sterilisation
 maintain sterility of the product
 permit safe withdrawal of the product
The purpose of packaging is to contain and protect the product.

CONTAINMENT

The European Pharmacopeia (PhEur) definition of a container is:
‘A container for pharmaceutical use is an article which contains or is intended to contain a
product and is, or may be, in direct contact with it. The closure is part of the container’.

Types of container for different sterile products include:

 Large volume parenterals (LVP): Rigid and flexible, glass and plastic
 Small volume parenterals (SVP): Ampoules, vials, prefilled syringes, novel devices
 Irrigations: Glass and plastics, sachets
 Eye drops: Glass and plastics
 Eye ointments: Plastics

A single-dose container holds a quantity of the preparation intended for total or partial use
as a single administration. lntraspinal injections, and intravenous injections greater than 15
mL must contain no bactericides and thus must be single use only.
A multi-dose container holds a quantity of the preparation suitable for two or more doses.
They must not contain an excessive number of doses and the period between first and last
doses should not be unduly prolonged. Multi-dose formulations require a bactericide.

In the case of parenteral products, a variety of materials have been used for containers.
Historically glass has been the most important but the use of plastics has increased
enormously in recent years. This topic is covered in the lectures of this course.

Glass ampoules are closed by fusion, but glass vials and bottles require some form of closure,
usually in the form of an elastomeric ‘bung’ or ‘wad’, coupled with a screw or crimp-on cap.
Plastics containers can also be closed by fusion but most use elastomeric components in ports
or septums.
No single closure formulation can meet all pharmaceutical needs and the relationship between
component supplier and dose-form manufacturer is very important.

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