Le Protest est un Indicateur Biologique Autonome pour le contrôle et la validation des procédés de stérilisation Vapeur et à l’Oxyde d’éthylène. Chaque unité est formée d’un tube plastique avec un bouchon, d’une ampoule cassable contenant un milieu de culture et d’une bandelette papier inoculée avec des spores.

Production OMF

Omaha Manufacturing Facility (OMF) – located in Omaha, Nebraska Primary Products – Spore Strips, ProTest, ProSpore Ampoule, Industrial Use BIs Customer Service Contacts: bicustomerservice@mesalabs.com 402.593.0781 or 800.728.5702 FAX: 402.593.0995

Activation

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Contrôles

Le témoin positif (indicateur non exposé au procédé de stérilisation) sera mis à incuber et devra montrer une turbidité et/ou un virage de couleur au jaune vif.

Interprétation

Si les spores ont été détruites, le milieu de culture ne change pas de couleur (vert pour EtO et violet pour la vapeur) et/ou ne présente pas de turbidité, la stérilisation a été efficace. Si le milieu de culture prend une coloration jaune et/ou présente une turbidité, les spores n’ont pas été détruites, la stérilisation n’a pas été efficace.

Informations Complémentaires

Technical Specifications for ProTest EO (Green)

Suitable for use in a hospital or industrial Ethylene Oxide sterilization. Contains B. atrophaeus* spores Log 6 Catalog # PT-1-6-25 (25 BIs) Catalog # PT-1-6-100 (100 BIs) Intended for use in EO 600mg/L, 60%RH, 54°C Sterilization failure evident by a dramatic green to yellow color change and/or turbidity.

Incubation 48 Hours

Expiration 18 months from date of manufacture

Certification Each lot of ProTest is certified for population, species, D-value, z-value (where applicable), purity and expiry.

Notes: The above catalog numbers for ProTest comply with the AAMI ST19/EN 866-7 (Steam) and AAMI ST24/EN 866-8 (Ethylene Oxide). * Derived from recognized reference strains as specified within USP, ISO or EN guidelines. These products are not certified as being representative of the reference strain and they should therefore not be used where a reference culture is specified.

Technical Specifications for ProTest Steam (Purple)

Intended for use in steam 121°C gravity and 134° C flash gravity (3 and 10 minute) cycles and 121-135°C pre-vacuum cycles. Suitable for use in hospital or industrial Steam Sterilization. Contains G. stearothermophilus* spores

Log 5 Catalog # PT-3-5-25 (25 BIs) Catalog # PT-3-5-100 (100 BIs)

Log 6 Catalog # PT-3-6-25 (25 BIs) Catalog # PT-3-6-100 (100 BIs) Sterilization failure evident by a dramatic purple to yellow color change and/or turbidity.

Incubation 24 Hours

Expiration 18 months from date of manufacture

Certification Each lot of ProTest is certified for population, species, D-value, z-value (where applicable), purity and expiry.

Notes: The above catalog numbers for ProTest comply with the AAMI ST19/EN 866-7 (Steam) and AAMI ST24/EN 866-8 (Ethylene Oxide). * Derived from recognized reference strains as specified within USP, ISO or EN guidelines. These products are not certified as being representative of the reference strain and they should therefore not be used where a reference culture is specified.

Manuals & Documents

ProTest Brochure ProTest IFU ProTest MSDS Population Assay – Spore Strips, Discs, Threads Reduced Incubation Study ProTest (EO) Reduced Incubation Study ProTest (Steam)

Informations complémentaires

Pour incuber les indicateurs biologiques Protest, vous pouvez utiliser l’incubateur 1410 MesaLabs suivant:

1410