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bioMerieux : Certificat de Controle Qualite / Quality Control CertificatePage 1

Reference - Lot : 51103-1000086680

Certificat de Contrle Qualit Quality Control Certificate


51103 BTS 3P irradi peptones vgtales avec indicateur color 5Kg / Irradiated TSB 3P Vegetable peptones with Color Indicator 5Kg
: 1000086680 : 2012-01-07
863027301 Revision : 1

Lot de Conditionnement /Packaging Lot Date d'expiration / Expiration date


Lot de Matire Premire / Raw material lot

Milieu deshydrat en seau / Dry media in bucket

Rsultats / Results CONFORME

Thorie / Theoretical results


beige clair, fine, lgre, homogne avec petits grains foncs / light beige, fine, light, homogeneous with little dark grains Facile froid, absence de rsidu non dissous / Easy when cold, no insoluble residual Liquide rose, limpide / pink clear liquid Test de filtrabilit test sur 3 membranes (PVDF, PES, Nylon) / Filtration procedure tested with 3 membranes( PVDF, PES, Nylon )

5 Kg
Aspect de la poudre / Appearance of powder Dissolution / Dissolution Aspect du milieu prt / Appearance of prepared medium Test de filtrabilit / Filtrability test PVDF: Millipore GVWP04700 (0.22) PES: Pall SUPA-200 (0.2) Nylon: Millipore GNWP04700 (0.22) Volume maximum filtr avant colmatage du filtre PVDF 0.5 bar sans prfiltration/ Maximum volume filtered before sealing of PVDF filter at 0.5 bar without prefiltration Volume maximum filtr avant colmatage du filtre PES 0.5 bar sans prfiltration/ Maximum volume filtered before sealing of PES filter at 0.5 bar without prefiltration Volume maximum filtr avant colmatage du filtre Nylon 0.5 bar sans prfiltration/ Maximum volume filtered before sealing of Nylon filter at 0.5 bar without prefiltration pH avant filtration/ pH before filtration

CONFORME CONFORME

989

L/m

698

L/m

815

L/m

7.4

7.3 +/- 0.2 Bactries / Bacteria Incubation 24h 30-35C, 72h 30-35C pour Clostridium / Incubation 24h at 30-35C, 72h at 30-35C for Clostridium Levures et moisissures /Yeasts and moulds Incubation 72h 20-25C / Incubation 72h at 20-25C

Fertilit / Growth performance


Conforme la mthode harmonise des pharmacopes / In compliance with harmonised protocol from Pharmacopoeia EP 5 , USP 29 , JP 15

Contrle par ensemencement direct / Control by direct inoculation (milieu strilis par filtration / medium sterilized by filtration) - Bacillus subtilis ATCC 6633 / NCTC 10400 - Staphylococcus aureus ATCC 6538 / NCTC 10788 - Pseudomonas aeruginosa ATCC 9027 / NCTC 12924 - Clostridium sporogenes ATCC 11437 / NCTC 12935 - Candida albicans ATCC 10231 / NCPF 3179 - Aspergillus brasiliensis ATCC 16404 / NCPF 2275 Irradiation / Irradiation

CONFORME

Croissance avec un inoculum < ou = 100 germes / Growth with inoculum < or = at 100 bacteria Croissance avec un inoculum < ou = 100 levures ou moisissures l Growth with inoculum < or = at 100 yeasts or moulds >= 25 KGy / >= 25 KGy

CONFORME CONFORME

bioMerieux : Certificat de Controle Qualite / Quality Control Certificate Reference - Lot : 51103-1000086680 Conditionnement / Packaging

Page 2

CONFORME
Par / By :

Conformit / Spcifications Conformity / Specifications

Lot accept le / Accepted on : 23/02/2011

Sylvain RIEUFREGIER Responsable Assurance Qualit Produit / Product Quality Assurance Responsible.

Ce document a t libr lectroniquement (Fin du document) / This document has been released electronically (End of document)