SPECIFIC BIOLOGICAL INDICATORS (BI’s) FOR VALIDATION OF STERILISATION BY H2O2 GAS Inoculated carriers with Geobacillus stearothermophilus spores ATCC 7953 are used for validation of the decontamination of isolators. 316L stainless steel is used as carrier, packaged singly in sterile tubes . ICARE is FDA registered under number 494155328 and is accredited (ISO 17025) for tests relating to biological indicators and inoculated carriers. Method of use: 1. Attach the supports equipped with a hook to the previously defined points in the isolator. (Note: if need be, a simple paper clip can be used). 1. Remove the inoculated carrier from the tube using pincers. 2. Attach the carrier to the previously fixed support using the eyelet. 3. At the end of the exposure time, recover the carrier using sterile pincers and insert it aseptically in a Trypticase Soy Broth tube. 4. Incubate for 7 days at 58°C ± 2°C before reading. The aim of the isolator decontamination procedure is to decontaminate surfaces. This is why indicators must be in a unpackaged form in the isolator. Tyvek-type packaging can act as a barrier against the gas and modify the concentration of the sterilising agent at the surface of the support, leading to false positive results. In addition, this barrier can also “capture” the sterilising agent after the exposure time and, consequently, give rise to false negative results. It is impossible to predict or provide models of the interactions between these two effects. Biopôle Clermont-Limagne – BP 60006 – 63360 Saint Beauzire – France – Tel. +33 473 339 999 – Fax. +33 473 339 977 [email protected]Each order is manufactured individually. For each expedited batch, a count is carried out on four BI’s and the corresponding analysis sheet is systematically dispatched. To limit the variability of BI’s resistance, transport is carried out under controlled and recorded refrigeration conditions. For deliveries outside of France, specific and validated packaging is used to allow the refrigeration temperature to be maintained for at least four days. The inoculated germ carriers are available with the following different standard counts: 10 6 , 10 4 or 10 3 spores/carrier. The expiry date is three months after the date of manufacturing. The manufacturing and refrigerated transport period mean you receive the BI’s within a maximum of 10 working days from receipt of the order.
Transcript
SPECIFIC BIOLOGICAL INDICATORS
(BI’s) FOR VALIDATION OF
STERILISATION BY H2O2 GAS
Inoculated carriers with Geobacillus stearothermophilus spores ATCC
7953 are used for validation of the decontamination of isolators. 316L
stainless steel is used as carrier, packaged singly in sterile tubes .
ICARE is FDA registered under number 494155328 and is accredited
(ISO 17025) for tests relating to biological indicators and inoculated carriers.
Method of use:
1. Attach the supports equipped with a hook to the previously defined points in the isolator.
(Note: if need be, a simple paper clip can be used).
1. Remove the inoculated carrier from the tube using pincers.
2. Attach the carrier to the previously fixed support using the eyelet.
3. At the end of the exposure time, recover the carrier using sterile pincers and insert it
aseptically in a Trypticase Soy Broth tube.
4. Incubate for 7 days at 58°C ± 2°C before reading.
The aim of the isolator decontamination procedure is to decontaminate surfaces. This is why
indicators must be in a unpackaged form in the isolator. Tyvek-type packaging can act as a
barrier against the gas and modify the concentration of the sterilising agent at the surface of the
support, leading to false positive results. In addition, this barrier can also “capture” the sterilising
agent after the exposure time and, consequently, give rise to false negative results.
It is impossible to predict or provide models of the interactions between these two effects.
Biopôle Clermont-Limagne – BP 60006 – 63360 Saint Beauzire – France – Tel. +33 473 339 999 – Fax. +33 473 339 977 [email protected]
Each order is manufactured individually. For each expedited batch, a count is carried out on four BI’s and the corresponding
analysis sheet is systematically dispatched.
To limit the variability of BI’s resistance, transport is carried out under controlled and recorded refrigeration conditions.
For deliveries outside of France, specific and validated packaging is used to allow the refrigeration temperature to be maintained
for at least four days.
The inoculated germ carriers are available with the following different standard counts: 106, 104 or 103 spores/carrier.
The expiry date is three months after the date of manufacturing.
The manufacturing and refrigerated transport period mean you receive the BI’s within a maximum of 10 working days from
receipt of the order.
INDICATEURS BIOLOGIQUES (IB)
SPECIFIQUES POUR LA VALIDATION DE
LA STERILISATION PAR H2O2 GAZEUX
Les porte-germes inoculés de spores de Geobacillus stearothermophilus
ATCC 7953 sont destinés à la validation de la décontamination des
isolateurs. Des supports inox 316L sont utilisés comme porte-germes et
emballés unitairement dans des tubes stériles.
ICARE est accrédité (ISO 17025) pour les essais relatifs
aux indicateurs biologiques et portes germes inoculés et enregistré auprès de
la FDA sous le numéro 4941553238.
Mode d’utilisation :
1 - Fixer des supports munis d’un crochet aux points préalablement définis dans l’isolateur.
(Note : En cas de besoin, un simple trombone peut être utilisé)
2 - Retirer le porte-germes inoculé du tube à l’aide d’une pince.
3 - Suspendre ce porte-germes au support préalablement fixé en utilisant l’œillet prévu à cet effet.
4 - A la fin du temps d’exposition, récupérer le porte-germes à l’aide d’une pince stérile et
l’introduire aseptiquement dans un tube de Bouillon Trypcase Soja.
5 - Incuber 7 jours à 58°C ± 2°C avant lecture.
Le process de décontamination des isolateurs a pour but de décontaminer les
surfaces. C’est pourquoi, les indicateurs doivent être présentés nus dans l’isolateur et non
emballés dans un contenant. Un emballage de type Tyvek peut agir comme une barrière au gaz et
ainsi modifier la concentration de l’agent stérilisant à la surface du support et entraîner des faux
positifs. Par ailleurs, cette barrière peut jouer également un rôle de captation de l’agent stérilisant
après le temps d’exposition, ce qui peut conduire à l’apparition de faux négatif.
Il est impossible de prévoir ou de modéliser les interactions entre ces deux effets.
Biopôle Clermont-Limagne – BP 60006 – 63360 Saint Beauzire – France – Tél. +33 (0)4 73 33 99 99 – Fax. +33 (0)4 73 33 99 77 [email protected]
Chaque commande fait l’objet d’une fabrication spécifique. Pour chaque lot expédié, une numération est effectuée sur 4 IB, le
bulletin d’analyse correspondant est systématiquement communiqué.
Pour limiter la variabilité de résistance des IB, le transport est effectué en condition de température réfrigérée maîtrisée et enregistrée. Pour les expéditions hors France, des emballages spécifiques et validés permettent une conservation de
la température réfrigérée pendant au moins 4 jours.
Les porte-germes inoculés sont disponibles en standard à différentes numérations : 106, 104 ou 103 spores/support.
La date de péremption est de 3 mois après fabrication.
Le délai de fabrication et le transport réfrigéré vous permettent de disposer des IB au maximum sous 10 jours ouvrés à réception
