MICROBIOLOGY, STABILITY, RESIDUE AND VALIDATION TESTS

– Microbiological Tests:

  • Sterility, bacterial endotoxin (LAL), bioburden / ISO 11737-2, USP 41 NF 36(85), ISO 11737-1

– Antimicrobial Efficacy Tests:

  • Bactericidal activity / TS EN 1276
  • Fungicidal activity / TS EN 1650
  • – Accelerated Shelf Life Process (1, 2, 3, 4, 5 years of stability) / ASTM F 1980
  • – EO Residue Tests (Curve drawing and ethylene chlorohydrin determination) / ISO 10993-7
  • – Gamma sterilization dose determination and routine dose control tests / ISO 11137-2
  • – Washing Validation Tests:
  • Oil and grease analysis / SM 5520-B
  • Detergent residue analysis / ISO 2211
  • TOC and SEM analyses
  • Corrosion tests / TS 5172 EN ISO 13402, TS EN 1618, BS EN ISO 10555-1
  • – Packaging Validation Tests (leakage and integrity) / ASTM F 1929, EN 868-5

Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

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For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

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