Sterilization Standards
Sterilization Standards
Sterilization Standards
Standardisation of outcomes
Why do we need them: eg of a sterilization process
To ensure that what we want is
SINGLE USE PRODUCTS
Committees populated by experts from industry, academia, Eg CEN – Committees populated by delegates nominated from
user groups & regulatory bodies. each EU countries standards body.
¾ The new document is trying to be all embracing ¾ Sterilizationusing heat in the presence of
covering such diverse processes as: moisture is a well understood process with a
¾ Air ballasted processes used in the Pharma industry long reliable history dating back over 200
for flexible IV containers where residual chamber air years.
is essential to prevent product damage ¾ The sections covering
¾ To: ¾ Sterilizing
Agent Characterisation,
¾ Porous Load processes used in hospitals for reusable ¾ Sterilizing
Agent specification &
surgical packs where residual chamber air is ¾ microbicidal effectiveness
dangerous and can compromise attainment of ¾ appear redundant.
sterility.
1995 version covered type & works testing, Attempts were made to have the steam
IQ and some routine monitoring. quality tests and the Bowie and Dick Test
New standard focuses on design and factory deleted from the document.
testing. This was being driven by the US
Useful IQ and routine tests have been Pharmaceutical Industry who have
moved to an informative annex. questioned the relevance and applicability of
ISO 17665 will cover IQ,OQ, PQ & routine the steam quality and Bowie and Dick tests.
monitoring. The document still contains these valuable
daily tests.
A thin tube 1500mm long with a capsule at The German delegation tabled a proposal to modify
one end for placement of an indicator. the thermocouple arrangements in the small load
thermometric test to include additional sensors in
the pack.
Wall Thickness = 0.5 +/-
+/- 0.025mm The reason for this is that there is evidence to show
Internal Diam.
Diam. = 2.0 +/-
+/- 0.1 mm that if an air pocket forms in a textile pack it can be
off centre. Thus a sensor placed in the geometric
Length = 1500 +/-
+/- 15 mm centre of the pack may not detect the lowest
Capsule Mass = 10.0 +/-
+/- 0.1g temperature depression present.
Free Capsule Vol = 6 +/-
+/- 1% of tot int vol For this reason a new arrangement has been
introduced which places sensors at different
Material = PTFE locations positioned along the vertical axis.
An explanation of integrators
Explanation of integrators Class 5
ISO 11138-
11138-3, biological indicator for moist heat:
D 121 is not less than 1.5 mins
Population is not less than 1 x 10 5
z is not less than 6
For Geobacillus stearothermophilus z typically = 10.
To achieve a 10 -6 inactivation level in a BI having these
characteristics we need an exposure time of 16.5 mins at
121C
(11 log reductions , 11 x 1.5 = 16.5 mins).
mins).
Survivors would be expected to be seen at 7 log reductions
(10 -2)
( 7 x 1.5 = 10.5 mins )