Page 11 - Laboratory manual for students FAR222 2019 20

FAR 222 Dosage Form II Laboratory Manual

PROTECTION

By protecting the product from contamination and degradation we are also protecting the
patient. It is necessary to protect the product from:

 chemical contamination
 particulate contamination
 microbiological contamination
 pyrogenic contamination
 physical damage during sterilisation and subsequent handling

i. Parenteral containers

A parenteral container should be completely sealed. Most official compendia make no
reference to leak testing and until recently there was little published guidance.
Leaks are most commonly due to, thermal or mechanical cracks or faulty seals. One of the
common types of test in use to detect ampoule leakers is dye intrusion challenge test. This
will be performed in the practical classes for ampoules preparation.

ii. Eye drop containers

Eye drops should be dispensed in glass or suitable plastic containers capable of being closed
so as to exclude microorganisms. Glass bottles usually used are amber coloured, vertically
ribbed, and made of either neutral glass or soda glass. These containers are fitted with a
phenolic plastic screw cap which incorporates a neutral glass dropper tube fitted with a natural
or synthetic rubber teat; alternatively, the complete dropper closure may be sterilised and
supplied separately in a sealed package, the bottle being closed with a plain phenolic plastic
screw cap fitted with a suitable liner. Applicator bottles made of a suitable plastic, or of a
combination of glass and a suitable plastic may also be used.

As the rubber teats may be incompatible with benzalkonium chloride, it is advisable, unless
their suitability has been established, to use silicone rubber teats for those eye drops in which
this antimicrobial substance is included.

When the eye drops are dispensed for domiciliary use, the closure should be covered by a
readily breakable seal. When the eye drops are dispensed for use in hospitals the closure
should always be covered with a readily breakable seal to distinguish between opened and
unopened containers. When eye drops are to be used in operating theatres, the complete unit,
including the external surface, must be sterile and enclosed in a sterile overwrap.

Not more than 10 mL of solution should be supplied in each container. If more than 10 mL is
dispensed at one time, the total quantity of solution should be distributed into an appropriate
number of containers.

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