ISO 14644 Cleanroom Environments for Medical Devices
Certify your cleanroom manufacturing environment with ISO 14644
The regulatory review and approval process for medical devices in the European Union (EU), the U.S. and many other jurisdictions requires manufacturers to provide evidence that their production and manufacturing facilities are designed and operated to ensure that finished products consistently meet the manufacturer’s specifications. The integrity of the manufacturing process is especially important for any medical device that comes in direct or indirect contact with a patient, since they can be easily contaminated with microbiological or chemical residues produced within the manufacturing and distribution environment.
Cleanrooms are ideally suited for the manufacturer of these types of medical devices. Cleanrooms are enclosed and environmentally-controlled spaces in which temperature, humidity, pressure and contaminant levels are kept within strict limits. The controlled environment provided by a clean room helps to ensure that products remain under controlled contamination levels throughout the production process, thereby reducing potential risks to patients. Therefore, appropriate cleanroom designs, and the implementation of personnel policies and procedures that control work within the cleanroom environment, are critical for the production of safe devices.
Cleanroom environments used for the production of medical devices are expected to meet the design specifications detailed in ISO 14644-4, Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up, and ISO 14644-5, Cleanrooms and associated controlled environments - Part 5: Operations. The control of microbial contamination in cleanrooms is expected to meet the requirements of ISO 14698, Cleanrooms and associated controlled environments - Biocontamination control, as well as Good Manufacturing Practice (GMP) Guidelines.
Medical device manufacturers face a number of challenges when designing and operating a state-of-the-art cleanroom environment. Often, the cleanroom design fails to meet the specifications required by the manufacturer and the requirements of the product being produced. In other cases, the manufacturer’s monitoring program is insufficient to quickly detect contamination problems when they can still be addressed, or before products have been released. In addition, medical device manufacturers may require evaluation of their cleanroom facilities when expanding their production lines. These and other challenges potentially compromise the quality of the devices being manufactured and expose patients to potential safety risks.
TÜV SÜD Industry Service Clean Cert provides medical device manufacturers with services related to cleanroom design and operation, from the earliest phases of cleanroom design. TÜV SÜD maintains a global network of hygiene experts, who are available to provide knowledgeable assistance regardless of location.
- Cleanroom/ISO 14644 expertise - TÜV SÜD is a single source for manufacturers seeking global regulatory review and approval of environmentally controlled device manufacturing and production facilities. In addition, TÜV SÜD Industry Service’s Clean Cert Program provides support in the design, construction and testing of cleanrooms.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices. Testing for device usability and functional safety are also available.
- GLP-compliant biocompatibility testing and biological evaluation - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
Cleanroom environments used for the production of medical devices are expected to meet the design specifications detailed in ISO 14644-4, Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up, and ISO 14644-5, Cleanrooms and associated controlled environments - Part 5: Operations. The control of microbial contamination in cleanrooms is expected to meet the requirements of ISO 14698, Cleanrooms and associated controlled environments - Biocontamination control, as well as Good Manufacturing Practice (GMP) Guidelines.
Medical device manufacturers face a number of challenges when designing and operating a state-of-the-art cleanroom environment. Often, the cleanroom design fails to meet the specifications required by the manufacturer and the requirements of the product being produced. In other cases, the manufacturer’s monitoring program is insufficient to quickly detect contamination problems when they can still be addressed, or before products have been released. In addition, medical device manufacturers may require evaluation of their cleanroom facilities when expanding their production lines. These and other challenges potentially compromise the quality of the devices being manufactured and expose patients to potential safety risks.
TÜV SÜD Industry Service Clean Cert provides medical device manufacturers with services related to cleanroom design and operation, from the earliest phases of cleanroom design. TÜV SÜD maintains a global network of hygiene experts, who are available to provide knowledgeable assistance regardless of location.
- Cleanroom/ISO 14644 expertise - TÜV SÜD is a single source for manufacturers seeking global regulatory review and approval of environmentally controlled device manufacturing and production facilities. In addition, TÜV SÜD Industry Service’s Clean Cert Program provides support in the design, construction and testing of cleanrooms.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices. Testing for device usability and functional safety are also available.
- GLP-compliant biocompatibility testing and biological evaluation - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Affairs Department, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.