Accredited Laboratory A2LA has accredited WUXI APPTEC, INC. Marietta, GA for technical competence in the field of

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1 Accredited Laboratory A2LA has accredited Marietta, GA for technical competence in the field of Biological Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILA C-IAF Communique dated 8 January 2009). Presented this 17th day of January For the Accreditation Council Certificate Number Valid to January 31, 2015 For the tests to which this accreditation applies, please refer to the laboratory's Biological Scope of Accreditation.

2 SCOPE OF ACCREDITATION TO ISO/lEC 17025: Kennestone Circle Marietta, GA Ginger Lane Phone: BIOLOGICAL Valid to: January 31, 2015 Certificate Number: In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following microbiological and biological tests for biopharmaceuticallbiotechnology, medical device/medical product, and textile industries: Sterility Testing - Validation of Sterility Tests Direct Inunersion, Membrane Filtration Fluid Path, In Situ Estimation of the Population of Microorganism on Product - Microbial Enumeration and Recovery Validation of Sterilization of Health Care Products - Radiation Bacterial Endotoxin Testing and Validation Microbial Analysis of Water Organism Identification - Gram Stain, Biochemical Profile, Ribosomal DNA Analysis, DNA Sequencing, Microscopic Fungal Analysis Evaluation of Environmental Monitoring Samples Test Method(s) USP<71 > 21 CFR Part 610 British Pharmacopoeia, Appendix XVI European Pharmacopoeia, Section Japanese Pharmacopoeia, Chapter 54 ANSIIAAMIIISO ANSIIAAMIIISO USP<61 > and <62> (Harmonized) USP<61 > (non-harmonized) USP<1227> ANSIIAAMIIISO AAMITIR33 USP<85>, USP<161> ANSIIAAMIIISO ST 72 USP<1231 > "Standard Methods for the Examination of Water and Wastewater", American Public Health Association, Current Edition Manual of Clinical Microbiology, Patrick R. Murray, et ai., 8 th Ed. USP <1116> 1 This accreditation also covers testing performed at the laboratory listed below. (A2LA Cert. No ) 01117/2013 &+'agelof Buckeystown Pike, Suite 350 I Frederick, Maryland I Phone: I Fax: I

3 1279 Kennestone Circle Marietta, OA Validation of the Sterilization/Reprocessing of Reusable Medical Devices Validation of Cleaning Efficacy of Reusable Medical Devices Qualitative Assessment of Antimicrobial Activity of Textile Material, Carpets, Polymeric Materials and Plastics Quantitative Assessment of Antimicrobial Activity of Textile Material, Carpets, Polymeric Materials and Plastics Antimicrobial Effectiveness Biological Indicators - Total Viable Spore Count Microbiological Examination of Non-Sterile Products Test MethodCs) AAMITIR 12 ISO AAMITIR30 AATCC Test Methods 147,30 Part III, 174 Part I, 174 Part III ASTM Test Methods 021 AA TCC Test Methods 100, 174 Part II, ASTM Test Methods E21S0, E2149, E247 I JIS Z 2S01 ISO USP<51 > USP<55> USP<61 >, "Microbial Enumeration," (Harmonized) USP<62>, "Test for Specified Microorganisms" (Harmonized) CA2LA Cert. No ) 01117/2013!?L+"" 2 0[2

4 Accredited Laboratory A2LA has accredited Marietta, GA for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/lEC 17025:2005 General Requirementsfor the Competence of Testing and Calibration Laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communique dated 8 January 2009). Presented this 17th day of January 2013., 0 #. Q, II, f II k 'I' {i I... r For the Accreditation Council Certificate Number Valid to January 31, 2015 For the tests to which this accreditation applies, please refer to the laboratory's Chemical Scope of Accreditation.

5 SCOPE OF ACCREDIT A non TO ISOIIEC 17025: Kennestone Circle Marietta, GA Ginger Lane Phone: CHEMICAL Valid to: January 31, 2015 Certificate Number: In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following chemical tests for biopharmaceuticallbiotechnology and medical device/medical product industries: Ethylene Oxide Residuals by GC (FID) (Ethylene Oxide, Ethylene Chlorohydrin, Ethylene Glycol by Water or Headspace Extraction) Heavy Metals Physicochemical Test Panel, Plastics Nonvolatile Residue Residue on Ignition Heavy Metals Buffering Capacity Total Organic Carbon Conductivity Residue Moisture Protein Assay by Sigma Test Kit Atomic Absorption Calcium, Lead, Silver, Copper, Magnesium, Rubidium, Cobalt, Sodium, Potassium, Nickel, Iron, Zinc Spectrophotometric Identification Tests by FTIR Test Method(s) ISO USP<231 > USP<661 > USP<643> USP<645> USP<921 > ASTMD5712 Client Specified Client-Specified ASTM El252 (A2LA Cert. No ) 01117/2013 &e10f Buckeystown Pike, Suite 350 I Frederick. Maryland I Phone: I m : I