BioSafety, Volume 1, Paper 7 (BY95007), June 24th 1995.
Online Journal, URL -
http://www.bdt.org.br/bioline/by
Biosafety Performance of Biotechnology Equipment:
Consideration of Performance Criteria and of Equipment
Categorisation.
Paul Hesselink (1), Brian Kirsop (2) and Ria Stoop (1)
(1) TNO Institute of Environmental Sciences, PO Box 6011,
2600
JA Delft, The Netherlands.
Draayer@tno.mw.nl
(2) Biostrategy Associates, Stainfield House, Stainfield,
Bourne,
Lincs PE10 0RS, UK.
bio@biostrat.demon.co.uk
Code Number: BY95007
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Text: 25K
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SUMMARY
This paper identifies leak tightness, cleanability and
sterilisability as the characteristics of biotechnology equipment
which are of primary importance in biosafety. Performance
criteria which assign equipment to one of three classes in each
of these respects are defined. Leaktightness classes have a
uniform definition over the range of biotechnology processes;
cleanability classification is recognised to depend on the nature
of the soil and of the cleaning protocol, and thus will vary with
the intended use. A distinction is drawn between equipment which
can be sterilised and that which cannot, but in which target
organisms can be destroyed. It is proposed that these criteria
could form the basis of biosafety classification of units of
equipment and of whole plant.
Copyright held by the author.
