Sterilization Validation of Medical Devices
Sterilization Validation of Medical Devices
Sterilization validation for Medical Devices plays a vital role in the overall quality and performance throughout the shelf life. Recall due to sterility issue… compensations and court cases with customers decrease in the share value… loss of brand image in the market. Sometimes we came across this type of headlines in the news for some well-known companies. what went wrong? How to avoid it for our companies!!
Many medical devices need to be supply in sterile condition and it is the manufacturer’s responsibility to provide assurance about the sterility of the device, till it reaches the intended user. Then how can a manufacturer do it?
Sterilization Validation Documents and Records
Sterilization documentation and records are crucial for EU MDR, EU IVDR and FDA 510k documentation to demonstrate that a medical device has undergone a validated sterilization process and meets the required sterility assurance levels. Here are some important documents and records associated with sterilization processes:
- Sterilization Validation Protocol which outline of the overall approach to sterilization validation consisting details of the sterilization method, parameters, and acceptance criteria.
- Biological Indicator (BI) Studies to check the status
- Physical and Chemical Indicators report
- Dose Setting Studies (for Radiation Sterilization) is applicable, documentation of studies to determine the appropriate radiation dose.
- Sterilization Process Performance Qualification (PPQ) data from the execution of the sterilisation process under routine production conditions
- Bioburden studies used to determine the pre and post bioburden of the product.
- Microbiological and Analytical Methods
- Validation Report summaries all data and results from the validation studies with conclusion
- Validation Master Plan (VMP) showing overall document outlining the strategy for validation activities, including sterilization validation.
- Standard Operating Procedures related to the sterilization process, Instructions for routine operation, maintenance, and monitoring of sterilization equipment.
- Routine Monitoring Records records of routine monitoring of sterilization parameters (e.g., temperature, pressure).
- Batch Records specific to each batch or lot of sterilized products. Information on the sterilization process parameters and results.
- Training Records Documentation of training provided to personnel involved in the sterilization process.Training records for operators and technicians.
These documents and records collectively provide a comprehensive overview of the sterilization process, its validation, and ongoing monitoring. They are essential for regulatory compliance and for demonstrating that the sterilization process consistently produces sterile medical devices. It’s important to follow relevant regulatory guidelines and standards, such as those provided by the FDA or ISO, to ensure that the documentation meets the required standards.
Sterile Medical Devices Applicable Standards
- EN ISO 11135-1:2007 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- EN ISO 11137-1:2015 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
- EN ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- AAMI/ISO TIR No.15844 Sterilization of Health Care Products—Radiation Sterilization— Selection of a Sterilization Dose for Single Production Batch
- AAMI/ISO 10993-7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residues
- AAMI/ISO 11737-1 Sterilization of medical devices—Microbiological methods, Part 1: Estimation of population of microorganisms on products
- AAMI/ISO 11737-2 Sterilization of medical devices—Microbiological methods, Part 2: Tests of sterility performed in the validation of a sterilization process