Validated to ensure batch after batch consistency

!
validated to ensure batch after batch
consistency...
plus...
!
each person knowing what to do...
and...
!
doing it correctly ....
!
first time...
!
every time...
to assure [to give assurance] that the product will
be completely fit [always] for its intended use.
7
Notes

GMP/M-024
'
Copyright 1999 Micron Video International Limited. All rights reserved.
°UNDERSTANDING STERILE PRODUCTION± Summary
Introduction
1. Contamination during the manufacture of
pharmaceutical products is minimized by
working to the principles of cGMP - ²current
Good Manufacturing Practice³ .
2. For a product to be sterile there must be a
complete absence of any living organism.
3. All injectable products, preparations for
use on open wounds or body cavities, eye
preparations and medical device implants
must be sterile.
4. Tests cannot be made on every unit of
every batch of every product, therefore
extra discipline , care and attention is
needed to control contamination during
the manufacturing process.
The Contaminants
MICROORGANISMS
5. Microorganisms are very small and invisible
to the naked eye.
6. They are viable, living organisms which will
flourish in warm and moist conditions such
as the human body.
7. Environments which are cool and dry will
help to control their reproduction.
8. Some may be harmless to healthy people but
can be harmful or fatal to the sick or injured...
9. ... therefore the complete absence of micro-
organisms is essential in sterile production.
PARTICLES
10. Particles range from visible to sub-micron
sizes.
11. They are the non-viable or inert particulate
matter which floats in the atmosphere or is
suspended in liquids.
12. Particles can be harmless if ingested through
the mouth, but may be harmful if injected or
are present in eye preparations.
13. Particles enable microorganisms to live and
colonize on them and must therefore be
eliminated from sterile production areas.
CHEMICALS
14. Chemicals can cause hazardous cross-
contamination from one process to another
through insufficient cleaning.
Sterile Environments
15. Cleanrooms provide the first line of defence
against environmental contamination.
16. They are designed to minimize the risk of
contamination reaching the product during
manufacture.
17. Air passes through HEPA filters to remove
particles and thus viable organisms before
entering the cleanroom.
18. Airborne contamination is maintained
at a low level due to the higher pressure
cleanroom air being recirculated and
refiltered continuously.
19. Incoming air is controlled to moderate
temperature and low humidity to inhibit
the growth of microorganisms.
20. Cleanroom design ensures that no aspect
of the environment will generate or hold
contamination.
21. Non-contaminating materials are used for the
room and the equipment contained within
it.
22. Every aspect is designed to be cleaned easily
and effectively.
8

GMP/M-024
'
Copyright 1999 Micron Video International Limited. All rights reserved.