NEWSLETTER – July 2012
Revision of NF EN ISO 11137-2 standard
The standard NF EN ISO 11137-2 was revised again in 2012. A new version is being written to correct a mistake in
interpreting the actions to take when a failure in a dose audit happens. This version should be released within a few
months.
ICARE laboratory would like to inform you about the details added to the new version of June 2012:
To remember
Little modifications
Main / Equivalent products definition ( 4.3.2
and 4.3.3) : it was added in the two paragraphs that
main or equivalent products to define the product
family could be chosen «Either a) randomly or b) by
a written operating procedure including the different
products that are likely to be considered main or
equivalent products ».
No re-evaluation required for
the sterilization dose of your
medical device
Enforceable date: 30 /06/ 2012
VDmax25 method and multiple production
batches (NOTE 9.2.1.1) : it is stated that the method
can be used only if the three average bioburden
values, determined for the calculation of the
verification dose, are less or equal to 1000.
Bioburden test : for all the methods : the
following note was added: « If no colony was
observed on the bioburden determination, it is
sometimes considered that the biological charge is
below the detection limit. Using the detection limit
value for the calculation of average bioburden may
lead to overestimation This overestimation could
affect the validity of the experimental verification
dose.». This note should not be interpreted as a
prohibition on using the detection limit as a
bioburden value in the calculation of the average. It
is not either required to use zero instead of the
detection limit. ICARE interprets this note as a
recommendation to limit the use of methods in
which detection limits are not adapted, so as to
justify a relevant use of detection limit as described
in the case of the note.
VDmax25 method ( 9.2.5 Part 4) : To carry
out the dose verification test : an important part of
the paragraph was deleted : « It should be taken into
account the ability of the product to stand the
microbial growth in order to choose the appropriate
batch ».
Sterilization dose audit ( 10.1) : it was added
that « All the actions resulting from the sterilization
dose audit must be applied to all the family
products».
Sterilization dose audit (
10.2.3 and
10.3.3.1) : it is stated that for bioburden
determination, the correction factor obtained from
the most recent validation must be applied. It is not
suggested that the dose should be recalculated.
Sterilization dose audit, interpretation of
results ( 10.3.5) : the interpretation concerning the
number of positive controls obtained was modified :
« if the presence of positive sterility controls can not
be attributed to improper execution of sterility
testing or incorrect distribution of VDmax25 or
VDmax15 or to a case specifically related to the
biologiccal load itself, the following steps should be
apply :
If 3 to 6 positive sterility controls are obtained,
immediately increase the sterilization dose and reestablish as soon as possible the sterilization dose
using another method. Continue using the increased
sterilization dose until the sterilization dose is reestablished.
If 7 or more sterility positive controls are
obtained, interrupt the sterilization at the dose
previously established. »
•Failure of the sterilization audit dose (
10.4) : a
new paragraph was written to replace the par.
10.3.7.1.2. It is specified that a particular study
should be performed and a corrective action taken. A
risk assessment on the treated batches must also be
undertaken at the sterilization dose that led to a
failure.
For further information, please do not hesitate contacting us: ICARE - Biopôle Clermont-Limagne F- 63360 Saint Beauzire
Tél. : +33(0) 473 331 917 Fax: +33(0) 473 339 977