N 1-1021 Rév. 6

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Agreement No. 633Section LaboratoiresATTESTATION D’ACCREDITATIONACCREDITATION CERTIFICATEN 1-1021 rév. 6Le Comité Français d'Accréditation (Cofrac) atteste que :The French Committee for Accreditation (Cofrac) certifies that:ICAREN SIREN : 402946917Satisfait aux exigences de la norme NF EN ISO/CEI 17025 : 2005Fulfils the requirements of the standardet aux règles d’application du Cofrac pour les activités d’analyses/essais/étalonnages en :and Cofrac rules of application for the activities of testing/calibration in:ENVIRONNEMENT / ENVIRONNEMENT CONTROLE (AIR, EAU et SURFACES) - QUALITE DEL'EAU - BIOCONTAMINATIONENVIRONMENT / CONTROLLED ENVIRONMENT (AIR, WATER and SURFACES) - WATER QUALITY- BIOCONTAMINATIONPRODUITS CHIMIQUES ET BIOLOGIQUES, EQUIPEMENTS MEDICAUX / DISPOSITIFS MEDICAUX- PRODUITS BIO-ACTIFS (MEDICAMENTS, COSMETIQUES, ANTISEPTIQUES ETDESINFECTANTS)CHEMICAL AND BIOLOGICAL PRODUCTS, MEDICAL DEVICES / MEDICAL DEVICES - BIOCIDESAND HYGIENE PRODUCTS (MEDICALS, COSMETICS, ANTISEPTICS AND DISINFECTANTS)réalisées par / performed by :ICAREBiopôle Clermont-LimagneBP 6000663360 SAINT BEAUZIREet précisément décrites dans l’annexe technique jointeand precisely described in the attached technical appendixL’accréditation suivant la norme internationale homologuée NF EN ISO/IEC 17025 est la preuve de lacompétence technique du laboratoire dans un domaine d’activités clairement défini et du bonfonctionnement dans ce laboratoire d’un système de management adapté (cf. communiqué conjoint ISOILAC-IAF en vigueur disponible sur le site internet du Cofrac www.cofrac.fr)Accreditation in accordance with the recognised international standard NF EN ISO/IEC 17025 demonstrates thetechnical competence of the laboratory for a defined scope and the proper operation in this laboratory of anappropriate management system (see current Joint ISO-ILAC-IAF Communiqué available on Cofrac web sitewww.cofrac.fr) .Le Cofrac est signataire de l’accord multilatéral d’EA pour l’accréditation, pour les activités objets de laprésente attestation.Cofrac is signatory of the European co-operation for Accreditation (EA) Multilateral Agreement for accreditation forthe activities covered by this certificate.LAB FORM 37 – Revision 08 – 08 January 2019Page 1/7

Agreement No. 633Date de prise d’effet / granting date :Date de fin de validité / expiry date :01/08/201931/07/2024Pour le Directeur Général et par délégationOn behalf of the General DirectorLa Responsable du Pôle Biologie-Agroalimentaire,Pole manager - Biology-Agri-food,Safaa KOBBI ABILLa présente attestation n’est valide qu’accompagnée de l’annexe technique.This certificate is only valid if associated with the technical appendix.L’accréditation peut être suspendue, modifiée ou retirée à tout moment. Pour une utilisation appropriée, la portée del’accréditation et sa validité doivent être vérifiées sur le site internet du Cofrac (www.cofrac.fr).The accreditation can be suspended, modified or withdrawn at any time. For a proper use, the scope of accreditation and itsvalidity should be checked on the Cofrac website (www.cofrac.fr).Cette attestation annule et remplace l’attestation N 1-1021 Rév 5.This certificate cancels and replaces the certificate N 1-1021 Rév 5.Seul le texte en français peut engager la responsabilité du Cofrac.The Cofrac's liability applies only to the french text.Comité Français d’Accréditation - 52, rue Jacques Hillairet 75012 PARISTél. : 33 (0)1 44 68 82 20 – Fax : 33 (0)1 44 68 82 21LAB FORM 37 – Revision 08 – 08 January 2019Siret : 397 879 487 00031www.cofrac.frPage 2/7

LaboratoriesSectionTECHNICAL ANNEXto accreditation N 1-1021 rev. 6The accreditation relates to the services provided by:ICAREBiopôle Clermont-LimagneBP 60006F-63360 SAINT BEAUZIREIn the following unit:- ICAREIt concerns:TECHNICAL UNIT: ICAREFIXED SCOPE#ENVIRONMENT / CONTROLLED ENVIRONMENT (WATER) / Sampling – Collection(Environmental testing– HP ENV)SUBJECTWater(including watersdescribed as per thepharmacopoeia, purifiedwaters, sterile water forinjection, highly-purifiedwaters)CHARACTERISTIC MEASUREDPRINCIPLE OF THEOR SOUGHTMETHODSampling of water formicrobiological and endotoxinanalysesInstantaneoussampling (single run)METHOD REFERENCENF EN ISO 14698-1In-house methodIC-EXT-PLV-EAFixed scope: The laboratory is recognized as competent to perform the sampling, in strict compliance with the methods mentionedin the scope of accreditation. Technical changes to the operating mode are not permitted.FIXED SCOPEENVIRONMENT / BIOCONTAMINATION / Sampling– Collection(Tests for assessing aerobiocontamination)SUBJECTControlled environment:-Health facility (cleanroom, operating room)-Production environment,laboratoryCHARACTERISTIC MEASUREDPRINCIPLE OF THEOR SOUGHTMETHODViable aerobic floraSampling by impactionon solid surface (agarmedium)NF EN ISO 14698-1In-house method INT025Yeasts - MouldsSampling by impactionon solid surface (agarmedium)NF EN ISO 14698-1In-house method INT025METHOD REFERENCEFixed scope: The laboratory is recognized as competent to perform the sampling, in strict compliance with the methods mentionedin the scope of accreditation. Technical changes to the operating mode are not permitted.LAB FORM 37 – Revision 08 – 08 January 2019Page 3/7

FIXED SCOPEENVIRONMENT / BIOCONTAMINATION / Sampling– Collection(Tests for assessing surface biocontamination)SUBJECTControlled environment:-Health facility (cleanroom, operating room)-Production environment,laboratoryType of surface (worksurface, staff, textiles,floor, equipment)CHARACTERISTIC MEASUREDPRINCIPLE OF THEOR SOUGHTMETHODViable aerobic floraSampling by applyinga "count tact" type boxNF EN ISO 14698-1In-house method INT022Yeasts - MouldsSampling by applyinga "count tact" type boxNF EN ISO 14698-1In-house method INT022METHOD REFERENCEFixed scope: The laboratory is recognized as competent to perform the sampling, in strict compliance with the methods mentionedin the scope of accreditation. Technical changes to the operating mode are not permitted.FIXED SCOPEENVIRONMENT / BIOCONTAMINATION / Microbiological analyses(Tests for assessing surface biocontamination)SUBJECTControlled environment:-Health facility (cleanroom, operating room)-Production environment,laboratoryType of surface (worksurface, staff, textiles,floor, equipment)CHARACTERISTIC MEASUREDPRINCIPLE OF THEOR SOUGHTMETHODMETHOD REFERENCEViable aerobic floraSample count using a“Count tact” type boxNF EN ISO 14698-1In-house method INT022Yeasts - MouldsSample count using a“Count tact” type boxNF EN ISO 14698-1In-house method INT022Fixed scope: The laboratory is recognized as competent to perform the tests, in strict compliance with the methods mentionedin the scope of accreditation. Technical changes to the operating mode are not permitted.FIXED SCOPEENVIRONMENT / BIOCONTAMINATION / Microbiological analyses(Tests for assessing aerobiocontamination)SUBJECTControlled environment:-Health facility (cleanroom, operating room)-Production environment,laboratoryCHARACTERISTIC MEASUREDPRINCIPLE OF THEOR SOUGHTMETHODMETHOD REFERENCEViable aerobic floraCount taken from asample by impactionon solid surface (agarmedium)NF EN ISO 14698-1Internal method INT025Yeasts - MouldsCount taken from asample by impactionon solid surface (agarmedium)NF EN ISO 14698-1Internal method INT025Fixed scope: The laboratory is recognized as competent to perform the tests, in strict compliance with the methods mentionedin the scope of accreditation. Technical changes to the operating mode are not permitted.LAB FORM 37 – Revision 08 – 08 January 2019Page 4/7

FLEX 1 SCOPECHEMICAL AND BIOLOGICAL PRODUCTS, MEDICAL EQUIPMENT / BIO-ACTIVE PRODUCTS /Microbiological analyses(Microbiology applied to fine chemistry, cosmetic, health and safety products: biological methods and medical devices – LABGTA 19/131- 3 and 160)SUBJECTMedical devicesMiscellaneouspharmaceutical or otherproductsCHARACTERISTIC MEASUREDPRINCIPLE OF THEOR SOUGHTMETHODBacterial endotoxin tests:Determination of theconcentration of bacterialendotoxins using the Limulusamoebocyte lysate (LAL) testPhotometric method(kinetic colorimetry)with interferenceidentificationMETHOD REFERENCEPharmacopoeia2.6.14 or USP 85 and 161 Method DFlexible scope FLEX1: The laboratory is recognized as competent to perform the tests, in compliance with the referencedmethods and their subsequent revisions.FLEX 1 SCOPE#ENVIRONMENT / WATER QUALITY / Microbiological analyses(Microbiological analyses of water – LAB GTA 23)SUBJECTPharmacopoeia waters(including highlypurified water, sterilewater for injection,purified water).Waters described asper the PharmacopoeiaCHARACTERISTIC MEASURED ORSOUGHTViable total aerobic germs,yeasts and mouldsBacterial endotoxinsPRINCIPLE OF THE METHODCount by membranefiltrationIncubationDetermination of theconcentration of bacterialendotoxins using theLimulus amoebocytelysate (LAL) testPhotometric methodswith interferenceidentification (kineticcolorimetry)METHOD REFERENCEPharmacopoeiaPE 2.6.12 orUSP 61 MonographsPharmacopoeiaMonographs n 1167PE 2.6.14 orUSP 85 and 161 Method DFlexible scope FLEX1: The laboratory is recognized as competent to perform the tests, in compliance with the referencedmethods and their subsequent revisions.LAB FORM 37 – Revision 08 – 08 January 2019Page 5/7

FLEX 1 SCOPECHEMICAL AND BIOLOGICAL PRODUCTS, MEDICAL EQUIPMENT / MEDICAL DEVICES / Microbiologicalanalyses(Microbiology applied to fine chemistry, cosmetic, health and safety products medical devices – LAB GTA 19/160)SUBJECTCHARACTERISTIC MEASURED ORPRINCIPLE OF THE METHODMETHOD REFERENCEControl germ contamination:Method for estimation ofmicroorganisms populationImmersion or elution,enumerationa- Filtrationb- Inclusionc- MPN and othersNF EN ISO 11737-1Sterile medical devicesSterility tests carried out whilevalidating a sterilisationprocess: Detection of microorganismsDirect inoculationFiltration over membraneNF EN ISO 11737-2Sterile medical devicesSterile pharmaceuticalproductsSterility tests outside the scopeof validation of a sterilisationprocess: aerobic andanaerobic bacteria, yeasts,moulds (product expiry datemust be checked in particular)Direct inoculationFiltration over membranePharmacopoeia 2.6.1USP 71 Tests on biological sterilisationindicatorsDetermination of numberof micro-organismsDetection of growthinhibitionDetermination of value DSurvival-destructionresponse characteristicNF EN ISO 11138-1NF EN ISO 11138-2NF EN ISO 11138-3Medical devicesSterile medical devicesSterile pharmaceuticalproductsSOUGHTFlexible scope FLEX1: The laboratory is recognized as competent to perform the tests, in compliance with the referencedmethods and their subsequent revisions.FLEX 1 SCOPECHEMICAL AND BIOLOGICAL PRODUCTS, MEDICAL EQUIPMENT / MEDICAL DEVICES /Physicochemical analyses(Tests to determine the toxicity of materials and medical devices)CHARACTERISTIC MEASUREDPRINCIPLE OF THEOR SOUGHTMETHODMedical devices sterilisedwith ethylene oxide (incontact with patient)Residues from sterilisationwith ethylene oxide (ethyleneoxide, ethylene hydrochlorideand ethylene glycol)Simulated-useextraction method:Quantification by GPCNF EN ISO 10993-7Medical devices sterilisedwith ethylene oxide (incontact with patient)Residues from sterilisationwith ethylene oxide (ethyleneoxide, ethylene hydrochlorideand ethylene glycol)Exhaustive thermalextraction method:Quantification by GPCNF EN ISO 10993-7SUBJECTMETHOD REFERENCEFlexible scope FLEX1: The laboratory is recognized as competent to perform the tests, in compliance with the referencedmethods and their subsequent revisions.#Accreditation made mandatory under French law, as detailed in the text cited in reference in documentCofrac LAB INF 99 and available from www.cofrac.fr.LAB FORM 37 – Revision 08 – 08 January 2019Page 6/7

Effective date: 01/08/2019Validity end date: 31/07/2024La Responsable d'accréditationThe Accreditation ManagerCassandre CHOPLINThis technical annex cancels and replaces technical annex 1-1021 Rev. 5.Comité Français d’Accréditation - 52, rue Jacques Hillairet 75012 PARISTel.: 33 (0)1 44 68 82 20 – Fax: 33 (0)1 44 68 82 21LAB FORM 37 – Revision 08 – 08 January 2019Siret: 397 879 487 00031www.cofrac.frPage 7/7

NF EN ISO 14698-1 Internal method INT025 Yeasts - Moulds Count taken from a sample by impaction on solid surface (agar medium) NF EN ISO 14698-1 Internal method INT025 Fixed scope: The laboratory is recognized as competent to perform the tests, in strict compliance

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