EXTRACTABLE & LEACHABLES SERVICES

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Stephanie Cooper
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1 LIFE SCIENCES EXTRACTABLE & LEACHABLES SERVICES LIFE INSPIRED, QUALITY DRIVEN QUALITY KNOWLEDGE EXPERIENCE

THE SAFEST MOST AFFORDABLE WAY TO GET TO MARKET, FAST The assessment of Extractables & Leachables (E&L) in bio/pharmaceutical products is an important step in drug product development and materials

SGS provides a complete service for testing extractables in container materials, medical devices, single use systems (SUS) and other consumables used in pharmaceutical production, such as filters,

2 THE SAFEST MOST AFFORDABLE WAY TO GET TO MARKET, FAST The assessment of Extractables & Leachables (E&L) in bio/pharmaceutical products is an important step in drug product development and materials qualification procedures. SGS provides a complete service for testing extractables in container materials, medical devices, single use systems (SUS) and other consumables used in pharmaceutical production, such as filters, tubes connectors and others, as well as leachables in final products. All tests are conducted in cgmp compliant laboratories using technologies that detect ultra trace levels. COMPREHENSIVE TESTING FOR: Container materials Medical devices Single-use systems Leachables in final products SGS LIFE SCIENCES SGS Life Sciences enables the medical and health innovators of the world to deliver life-changing solutions in the quickest, safest and most efficient way, helping improve the lives of many. We provide the highest quality services, reliable expertise and guidance through our network of labs conveniently located around the globe. 2

3 THE SGS ADVANTAGE QUALITY & COMPLIANCE Experts in meeting regulatory compliance Submission ready analytical reports Reliable and accurate testing: Studies engineered to your unique needs Fully accredited, professionally recognized organization Third party CRO delivering unbiased results State-of-the-art facilities, equipment and techniques SPEED & DEVELOPMENT Speed up the drug development process and bring your product to market quickly; our Extractables evaluation services help you evaluate which analytes will be helpful for developing methods for testing Leachables, reducing the time required for Leachables testing by months. RESOURCE MANAGEMENT E&L testing is an essential component of the drug development process and QbD initiatives, but testing programs can be quite expensive. Our Full Time Equivalent (FTE) services ensure high efficiency and quick turnaround time while allowing you to focus on your core competencies, as well as provides cost savings by allowing you to avoid building specialized facilities, hiring staff, etc. OUR FTE SOLUTION: 1. Ensures high efficiency 2. Quick turnaround time 3. Cost savings ABOUT SGS SGS is the world s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 95,000 employees, we operate a network of more than 2,400 offices and laboratories around the world. GET TO MARKET QUICKLY, SAFELY & EFFICIENTLY DISCOVERY CLINICAL MARKET DISEASE PRECLINICAL ROUTINE PRODUCTION CURING 3

INDUSTRY GROUP LEADER IN DOW JONES SUSTAINABILITY INDEX RobecoSAM Gold Class sustainability award winner 4 years in a row Ecovadis Gold Rating Sustainability Performance 3 years in a row RobecoSAM

4 INDUSTRY GROUP LEADER IN DOW JONES SUSTAINABILITY INDEX RobecoSAM Gold Class sustainability award winner 4 years in a row Ecovadis Gold Rating Sustainability Performance 3 years in a row RobecoSAM Industry Mover CDP Climate A List 356+ community projects OUR GUIDING PRINCIPLES At SGS, we are guided in all that we do by the values of trust, quality, expertise, reliability, global partnership and integrity; these are the bedrock upon which our organization is built. We also believe that while we are in the business of life sciences, our commitment lies equally in life-saving. This mean taking responsibility for our own operations and practices to ensure we are protecting and preserving all life, in its many forms: PEOPLE ANIMALS PLANET We do not test on weapons or anything that could be used to threaten life. As a cruelty-free organization, we do not conduct any tests on animals. We are an award-winning leader in sustainability and carbon neutral organization. 4

E&L SERVICES TESTING Test strategy planning and data evaluation based on the available information Development of tailored study design for extractables and leachables or chemical characterization,

extractables in materials made from polymers, metals and ceramics Characterization of extractables by chromatographic and spectroscopic investigations Identification of a material and the

properties of materials Chemical and structural change

5 E&L SERVICES TESTING Test strategy planning and data evaluation based on the available information Development of tailored study design for extractables and leachables or chemical characterization, according pharmaceutical standards and ISO part 12/18 Extractables profiling (inorganic and organic extractables) Sequential extractions and alternative extraction techniques for isolating extractables in materials made from polymers, metals and ceramics Characterization of extractables by chromatographic and spectroscopic investigations Identification of a material and the identification and quantitation of the chemicals present in materials by chemical characterization Identification and evaluation of the physico-chemical, mechanical, morphological and topographical properties of materials Chemical and structural changes (e.g. by DSC) on polymeric materials after stressing by temperature or irradiation Determination of the Analytical Evaluation Threshold (AET) Calculation of the AET based on Safety Concern Threshold (SCT) or Threshold of Toxicology Concern (TTC) and ICH M7 guideline Toxicological assessments and method development and validation of potential leachables in pharmaceutical products and from medical devices Performing leachables studies or simulated use studies on pharmaceutical products and medical devices Reporting and evaluation of results within the current guidelines TESTING & ASSESSMENT TECHNOLOGIES Our extractables and leachables testing and assessment technologies include: UPLC and HPLC-MS/MS, HPLC Q-Tof(ESI,APCI), HPLC-UV, DAD, HS- GC,HS-GC-MS, GC-QTof (EI, CI) Semi-Preparative Fraction Collection by HPLC Accurate Mass Assignments by Mass Spectrometry Peak Purity GC (FID,ECD,FID-NP), GC-MS GC-TEA (nitrosamines) HPLC-MS/MS (ESI) perfluorinated acids (PFCA) ICP-OES, ICP-MS, AAS, IR IC-ED (anions, cations) FTIR Accelerated Solvent Extractions (ASE) Soxhlet and Reflux Extraction Static or dynamic liquid extraction by pumping through; simulated use and migration studies TOPOGRAPHICAL METHODS & MORE We provide topographical methods and other methods for physical-chemical material characterization, surface contamination, risk of delamination or surface fracture after stressing including: Thermoanalysis (TGA, DSC) X-Ray Fluorescence Analysis (XRF) Materialography, Light Microscopy Electron Microscopy (REM, SEM) Electron Probe Microanalyzer (ESMA) Atomic-force Microscopy (AFM) X-ray Diffraction (XRD, XRT) Photoelectron Spectroscopy (XPS) Auger Electron Spectroscopy (AES) Spreading Resistance Profiling (SRP) Secondary Ion Mass Spectronomy (SIMS-Tof) 5

6 FIND US HERE AMERICAS 6 EUROPE ASIA USA GERMANY CHINA New York City (Fairfield, NJ) Frankfurt (Wiesbaden) Shanghai us.pharmaqc@sgs.com de.pharmaqc@sgs.com cn.pharmaqc@sgs.com

7 YOUR TRUSTED GLOBAL TEAM 7

PHARMACEUTICAL TESTING

WHITEHOUSE, NJ PHARMACEUTICAL TESTING Pharmaceutical Expertise for GMP & CMC Testing Our Pharmaceutical Expertise With more than 20 years of experience in a variety of industries, our Whitehouse, New Jersey