BioSafety, Volume 1, Paper 2, April 26th 1995
Online Journal, URL - http://www.bdt.org.br/bioline/by
Containment aspects of couplings and connections for
biotechnology plant
G Leaver, I W Stewart, and J S Deans
Code Number: BY95002
Size of Files:
Text: 58K
Graphics: Line Drawings (Gif) - 89K
SUMMARY
There is much interest in the design of bioprocess plant to
satisfy the biosafety requirements of regulations and
associated standards. This paper focuses on containment
testing of couplings and connections which are often critical
components of a bioprocess plant. Four couplings and four seal
types were investigated by repeated sterilisation/cooling
cycle duties together with preliminary work on the effect of
contact with cleaning agents. The overall result was that
containment was retained although seals distorted in many
cases which would make cleaning-in- place difficult. One
failure was noted on a coupling which was attributed to the
seal being unsuited for the intended application. The results
provided evidence that couplings used in bioprocess
applications should offer adequate protection for all levels
of containment requirements, provided that the seals are
routinely tested and replaced as part of an overall
maintenance schedule. It is suggested that the seals should
always be tested before use at higher containment
requirements.
