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SGS Highlights Strengthened Cleaning Validation Requirements for Medical Devices Amid Evolving Regulatory and International Standards
(IN BRIEF) SGS has highlighted evolving regulatory and international expectations for cleaning validation of medical devices, emphasizing the importance of validated cleaning processes in controlling contamination and supporting product safety. The company points to the Beijing Municipal Medical Products Administration’s … Read the full press release →
Posted in Business, Healthcare, Pharma & Biotech, Science, Security & Safety, Switzerland
Tagged 2024 Edition Draft for Comment, AAMI, Applied Technical Services, ASTM F2459, ASTM F2847, ASTM F3127, automated cleaning systems, Beijing Municipal Medical Products Administration, bioburden, biocompatibility, bluesign, BMPA, Brightsight, cleaning effectiveness, cleaning families, cleaning methods, cleaning process validation, contamination control, cytotoxicity testing, disinfection, elemental impurities, EN 13038, endotoxin testing, EP 2.6.14, GB/T 19973.1-2023, GMP, GMP Validation Guide 2023 Edition, good manufacturing practice, Guidelines for Inspection of Medical Device Cleaning Process Validation, hydrocarbons, ionic residues, ISIN CH1256740924, ISO 10993-5, ISO 11737-1, ISO 19227, laboratory testing, lipophilic residues, medical device cleaning validation, medical device safety, medical devices, microbiological testing, Nutrasource, orthopedic implants, particulate contamination, process parameters, product quality, QMS, Quality Management System, re-validation, regulatory compliance, retrospective validation, SGS, SGS Expands Focus on Comprehensive Cleaning Validation Testing for Medical Device Manufacturers, SGS Highlights Risk-Based Cleaning Validation Approaches for Medical Devices and Orthopedic Implants, SGS Laboratories, SGS Outlines ISO 19227 and Updated Regulatory Expectations for Medical Device Cleaning Validation, SGSN, SIX Swiss Exchange, sterilization, TOC, total organic carbon, USP, validated analytical methods, validation protocols, visual inspection, worst-case testing, YY 0321.3-2022, YY/T 1556-2017