STS Directory Accreditation number: STS 0268

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1 International standard: ISO/IEC 17025:2005 Swiss standard: SN EN ISO/IEC 17025:2005 Bioexam AG Maihofstrasse 95a P.O.B CH-6000 Lucerne 6 Head: Candid Bucher Responsible for MS: Nathalie Amstein Telephone: mailto:mail@bioexam.ch Internet: Initial accreditation: Current accreditation: to Scope of accreditation see: (Accredited bodies) Scope of accreditation as of Testing laboratory for microbiological examinations in the fields of pharmaceuticals, medical devices, cosmetics, foodstuffs, environment, and hygiene (production, personnel and hospital hygiene) Pharmaceuticals and medicinal products Sterility test Ph. Eur ; USP <71> Aerobic mesophilic count (TAMC) Yeasts and moulds (TYMC) Bile-tolerant gram-negative bacteria Ph. Eur ; USP <61> Ph. Eur ; USP <61> Ph. Eur ; ; USP <62> Candida albicans Ph. Eur ; USP <62> Clostridia Ph. Eur ; USP <62> Escherichia coli Ph. Eur ; ; USP <62> / M rsp/bgs 0268stsvz_engl 1/6

2 Pseudomonas aeruginosa Ph. Eur ; USP <62> Salmonellae Ph. Eur ; ; USP <62> Staphylococcus aureus Ph. Eur ; USP <62> Determination of the population of microorganisms on products (bioburden) Efficacy of antimicrobial preservation Test for bacterial endotoxins (gel clot method) Evaluation of media fills (aseptic process validation) Zone of growth inhibition determination Determination of the minimal inhibitory and the minimal bactericidal concentrations ISO Ph. Eur Cosmetics Aerobic mesophilic count ISO Yeasts and moulds ISO Specified and non-specified microorganisms (qualitative) Efficacy of antimicrobial preservation Ph. Eur , USP <85> PIC/S, document no , 2010 ASM chap. 68; AV ASM chap. 68/70-72 (mod.); AV ISO ISO Food Food sampling SAS document no. 333.dw; HyV; LGV; AV Quantitative test methods Aerobic mesophilic count Aerobic mesophilic microorganisms not belonging to the fermentation flora Aerobic mesophilic spores Aerobic thermophilic count Aerobic thermophilic spores ISO and -2; GME SFC 1988 chap. 56 / 7.03 SFC 1988 chap. 56 / 7.02 (mod.); AV ISO and -2 (mod.); AV SFC 1988 chap. 56 / 7.02 (mod.); AV / M rsp/bgs 0268stsvz_engl 2/6

3 Anaerobic mesophilic count SFC 1988 chap. 56 / 7.04 Anaerobic mesophilic spores Anaerobic thermophilic count Anaerobic thermophilic spores Bacillus cereus (presumptive) SFC 1988 chap. 56 / 7.05 (mod.); AV SFC 1988 chap. 56 / 7.04 (mod.); AV SFC 1988 chap. 56 / 7.05 (mod.); AV corresponding to ISO 7932 Bifidobacteria SFC 1996 chap. 56 Clostridia, sulfite-reducing Baumgart 2012 chap. III.1.1.; AV Clostridium perfringens SFC 1408 (mod.); AV Coliforms Enterobacteriaceae ISO corresponding to ISO 4832 Enterococci SFC 1406 (mod.); AV Escherichia coli ISO Lactic acid bacteria (mesophilic) ISO Listeria monocytogenes / Listeria spp. corresponding to ISO Pseudomonads ISO (mod.); AV Staphylococci, coagulase-pos. (S. aureus) corresponding to ISO Sulfite reducing anaerob. spores GME (mod.); AV Qualitative test methods Bacillus cereus (presumptive) ISO Campylobacter (thermotolerant) ISO Coliforms ISO (mod.); AV Cronobacter spp. ISO/TS (mod.); AV Enterobacteriaceae ISO Escherichia coli ISO (mod.); AV ; GME / M rsp/bgs 0268stsvz_engl 3/6

4 Chip fats and oils Drinking, mineral and process water Hygiene Listeria monocytogenes / Listeria spp. Salmonellae Determination of the polar compounds corresponding to ISO corresponding to ISO 6579; GME Food Oil Sensor (CAPSens 5000); GV Aerobic mesophilic count ISO and -2 Clostridium perfringens SFC 1408 (mod.); AV Coliforms ISO 4832 (mod.); AV Enterococci SFC 1406 Escherichia coli ISO (mod.); AV Legionellae ISO Pseudomonas aeruginosa SFC 1405 Microbial count of surfaces Contact plate method ISO Swab method ISO Washing method ISO Microbial count of air Impaction method MBV MAS-100 Air Sampler; AV Bathing water Aerobic mesophilic count ISO and -2 Escherichia coli ISO (mod.); AV Legionellae ISO Pseudomonas aeruginosa SFC 1405 Enterococci SFC 1406 Water for dialysis Aerobic mesophilic count ISO Production water (pharmaceutical field) Aerobic mesophilic count (TAMC) Ph. Eur.: and monographiesi no. 0008, 0169, 1927, and 2249 USP: <61> and <1231> Coliforms ISO 4832 (mod.); AV Enterococci SFC 1406 Escherichia coli ISO (mod.); AV / M rsp/bgs 0268stsvz_engl 4/6

5 Bioindicators for disinfection and sterilisation processes Endoscopes Pseudomonas aeruginosa SFC 1405 Growth testing (qualitative and quantitative) Microbial analysis of disinfected endoscopes Ph. Eur ; USP <55>; VHD RKI; AV Faeces Campylobacter spp. ASM chap. 53; AV Identification of microorganisms Chemical disinfectants and antiseptics Antimicrobial polymers Salmonellae ASM chap. 35; AV Macroscopic and microscopic identification of bacteria and fungi Biochemical identification of bacteria Mass spectrometric identification of bacteria and yeasts bactericidal activity (basic test; phase 1) fungicidal/yeasticidal activity (basic test; phase 1) bactericidal activity (phase 2 / step 1) fungicidal/yeasticidal activity (phase 2 / step 1) Quantitative surface test, bactericidal and fungicidal activity (phase 2 / step 2) Hygienic hand disinfection (phase 2 / step 2) Disinfecting hand washing (phase 2 / step 2) Determination of the antimicrobial activity Microscopy, different staining methods; AV , CL Different traditional procedures: AV , CL MALDI Biotyper (Bruker Daltonics GmbH); AV EN 1040 EN 1275 EN 1276 EN 1650 EN EN 1500 EN 1499 ASTM E (mod.); AV / M rsp/bgs 0268stsvz_engl 5/6

6 Abbreviation ASM ASTM Baumgart EM GME Signification J. Versalovic et al. (eds.), Manual of Clinical Microbiology, 10th edition, ASM Press, Washington, DC, 2011) American Society for Testing and Materials J. Baumgart, B. Becker, R. Stephan (eds.), Mikrobiologische Untersuchung von Lebensmitteln (Loose-leaf collection), Behr s, Hamburg European Standard Monography Standardised Methods for the Testing of Edible Gelatin of the GME (Gelatin Manufacturers of Europe) HyV Swiss Hygiene Regulation (SR ) ISO International Standardisation Organisation LGV Federal Act on Foodstuffs and Utility Articles (SR ) Ph. Eur. PIC/S RKI SFC TAMC TYMC USP VHD Pharmacopoea Europaea, current edition Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Robert Koch Institute ( Richtlinie für Krankenhaushygiene und Infektionsprävention ) Swiss Food Compendium Total Aerobic Microbial Count Total Combined Yeasts and Moulds Count United States Pharmacopeia, current edition Vereinigung der Hygiene-Fachkräfte der Bundesrepublik Deutschland e.v. ( Checkliste hygienerelevanter Umgebungsuntersuchungen ) * / * / * / * / * / M rsp/bgs 0268stsvz_engl 6/6

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