{"id":3917,"date":"2026-05-24T09:35:13","date_gmt":"2026-05-24T06:35:13","guid":{"rendered":"http:\/\/sw-themes.com\/porto_dummy\/?post_type=event&p=3917"},"modified":"2026-06-22T12:20:35","modified_gmt":"2026-06-22T09:20:35","slug":"process-and-infrastructure-validation-consultancy","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/proses-ve-altyapi-validasyon-danismanligi\/","title":{"rendered":"Process and Infrastructure Validation Consulting"},"content":{"rendered":"

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\u2699\ufe0f Process and Infrastructure Validation Consulting<\/h4>\n

Standard-Compliant Verification and Certification of Critical Processes in Medical Devices<\/h4>\n

Validation of infrastructure and specialized manufacturing processes used in medical device production is a cornerstone of product safety and regulatory compliance. At Era Management, we plan your process validations, prepare protocols, and fully manage reporting processes in accordance with ISO and MDR\/FDA requirements.<\/p>\n

All tests are conducted in collaboration with accredited laboratories, and we manage the entire preparatory process, including test planning and product selection.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
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1. Infrastructure Process Validations<\/h3>\n

Clean Room and Environmental Validation<\/h4>\n
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  • \u2022 ISO 14644-1\/2: Particle counting and class verification<\/li>\n
  • \u2022 ISO 17141: Microbial contamination control<\/li>\n
  • \u2022 Measurements of temperature, humidity, pressure difference, and air exchange rate.<\/li>\n
  • \u2022 Validation protocol and annual review plans<\/li>\n<\/ul>\n

    Sterilization Validation<\/h4>\n
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    • \u2022 ISO 11135: EtO, ISO 11137: Gamma, ISO 17665: Moist heat (autoclave)<\/li>\n
    • \u2022 Sterilization cycle verification, use of biological indicators, loading configuration<\/li>\n
    • \u2022 Dose calculation, penetration and aeration validation<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
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      2. Specific Process Validations<\/h3>\n

      Production Processes<\/h4>\n

      \u2022 Plastic injection molding, CNC machining, casting, ultrasonic cleaning, and surface coating validation.<\/p>\n

      Tekrar Kullan\u0131m & Temizlik<\/h4>\n

      \u2022 Reprocessing\/cleaning validation (ISO 17664) and sterilization processes for reusable products.<\/p>\n

      Software and Hardware Processes<\/h4>\n

      \u2022 Embedded software validation, process software (ERP, SCADA) validation, and software lifecycle management (SDLC).<\/p>\n

      3. Test and Laboratory Coordination<\/h3>\n

      Defining testing needs, selecting an accredited laboratory, and configuring test settings for products based on worst-case scenarios.<\/p>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
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      Process Validation Flow<\/h3>\n