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ISO 11737-1

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ISO 11737-1

ISO 11737-1, the standard published by the International Organisation for Standardisation (ISO) entitled ‘Sterilisation of healthcare products – Microbiological methods – Part 1: Determination of the microorganism population on products”, i.e. “Sterilisation of healthcare products – Microbiological methods – Part 1: Determination of the microorganism population on products”. It is generally referred to as the standard for determining the microbial load (bioburden). The current base text is ISO 11737-1:2018; any amendments and the status of national implementation should be checked against the relevant official sources before work commences.

Note on regulatory status: The standard applies to sterilisation validation (ISO 11135, ISO 11137, ISO 17665, ISO 14937), as well as the sterility assurance level (SAL) and the determination of the sterilisation dose as a fundamental input parameter for the generation of bioburden data. Under the MDR 2017/745, it serves as a reference for the bioburden monitoring programme in the technical dossier. Together with the sterility tests specified in the pharmacopoeias (USP <71>, EP 2.6.1) and ISO 11737-2/-3, it forms part of a comprehensive sterility assurance system.

What is bacterial load and why is it important?

Die Keimbelastung (Bioburden) ist eine Population lebender Mikroorganismen, die sich auf oder in einem Produkt befindet. Keimbelastungsdaten werden für folgende Zwecke verwendet:

  • Sizing the sterilisation process: determining the selected sterilisation conditions (dose, time, concentration) so that the target SAL is achieved
  • Dose determination in irradiation sterilisation: Under ISO 11137-2, bioburden data are required for VDmax and other methods
  • Routine testing: Monitoring the continuity of microbiological control of the production process and trend analysis
  • Assessment of process changes: Assessment of the impact of changes to raw materials, suppliers, the production environment or the process on microbiological contamination
  • Interpretation of sterility test results: Assessment of a negative sterility test result in conjunction with microbiological contamination data

Why is this being done?

ISO 11737-1 is used for the following scientific and regulatory purposes:

  • Sizing the sterilisation process: determining the sterilisation conditions required to achieve the target SAL
  • Dose determination in radiation sterilisation: Provision of bioburden data for dose adjustment procedures in accordance with ISO 11137-2 (Method 1, Method 2, VDmax)
  • MDR compliance: Provision of the necessary data for sterility assurance and sterilisation validation under the EU Medical Devices Regulation (2017/745)
  • Control of the production process: Monitoring the impact of the production environment, raw materials, staff and process hygiene on microbiological contamination
  • Change management: Assessment of the impact of changes to design, materials, suppliers, the production process, packaging or sterilisation on microbial contamination
  • Routine monitoring and trend analysis: Continuous monitoring of the microbial load in production batches, detection of instances where limit values are exceeded, and identification of trends
  • Integration into sterility testing: Support with the evaluation of sterility tests in accordance with ISO 11737-2
  • Root cause analysis: Assistance in identifying the cause in the event of a sterilisation failure or a limit being exceeded
  • Support with regulatory submissions: Use as evidence of sterilisation validation and the bioburden monitoring programme for FDA 510(k), EU MDR and other applications
  • Evidence-based approach: Contribution to the comprehensive assurance of product sterility in conjunction with data on sterility (ISO 11737-2), endotoxins (ISO 11737-3), packaging (ISO 11607) and biocompatibility (ISO 10993)

ISO 11737-1 does not certify the sterility of the product; it enables a quantitative assessment of the microbial load prior to sterilisation. The results should be interpreted in the context of sterilisation validation, sterility testing and SAL calculations.

As NanoTest, we carry out microbial contamination testing in accordance with ISO 11737-1 with scientific rigour, utilising our accredited laboratory facilities and quality management system.

Please feel free to contact NanoTest for information on method selection, validation and the determination of correction factors, sample preparation, counting procedures, test schedules and report preparation in connection with your bioburden testing in accordance with ISO 11737-1.

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