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Sterile Clean Room Requirements for Medical Device Production

This document compiles key requirements for sterile clean rooms used in the production of medical devices, referencing various national and international standards.


Standards Referenced:

  • ISO/DIS 14644: Cleanrooms and associated controlled environments

  • GB50073-2001: Code for design of clean room workshop (superseded)

  • GMP-97: Good Manufacturing Practice for Medical Devices (specification for clean room workshop of medical equipment packaging workshop)

  • GMP-98: Good Manufacturing Practice for Drugs

  • JGJ 71-90: Code for construction and collection of clean room (superseded)

  • GB 50243-2002: Code for construction and acceptance of ventilation and air conditioning engineering

  • FS 209E-92: Federal Standard Cleanroom and Workstation Requirements (US)

  • GB50457-2008: Code for the design of clean workshop in pharmaceutical industry


According to the requirements of relevant norms, the construction of clean rooms in accordance with relevant standards is required for sterile medical device production workshops, drug production workshops, medical biology laboratories, operating rooms and so on. In the construction or reconstruction of clean room, we can not rely on the final acceptance to ensure the quality of the clean room, we must be strict from the design and equipment selection stage, in the construction of the whole process of the main key points of strict inspection, supervision, and regular monitoring in the actual use of the clean room in order to ensure that the clean room to meet the design specifications and the use of the requirements.


Aseptic medical devices is any labeled "sterile" medical devices, the production of clean room is to ensure the quality of sterile medical devices basic conditions, control the environment of the production process of sterile medical devices and standardize its production, to prevent environmental contamination of sterile medical devices, the clean room must meet the requirements of the specified environmental parameters to the construction and regular monitoring.


Sterile Clean Room Requirements for Medical Device Production

Medical device cleanroom construction needs to be considered from the following issues:

  1. purification materials needed for medical device packaging workshop;

  2. the design, installation, commissioning, maintenance and other comprehensive services for medical device plant and medical device packaging workshop;

  3. medical device packaging workshop air-conditioning purification;


Suspended particles, planktonic bacteria, settled bacteria

Test conditions such as can not meet the requirements of the specified environmental parameters (temperature and humidity, wind speed, the number of air exchanges, static pressure difference within the specified range), the key item

suspended particles, planktonic bacteria or settled bacteria test results should be regarded as invalid. As temperature, relative humidity, wind speed, air change times, static pressure difference together constitute the microclimate of the clean room, is an important indicator of the normal maintenance of the clean room. Only in this way can we comprehensively and systematically monitor the production of clean room, in order to ensure the scientific and accuracy of the data of clean room performance monitoring, the testing department in the key items of suspended particles, microorganisms test, should be carried out at the same time the temperature, relative humidity, the number of air changes, static pressure and other prerequisites of the test.


Design standards for temperature, relative humidity, wind speed, air changes, and static pressure difference in pharmaceutical clean rooms and sterile medical device clean rooms are both based on the "Code for the Design of Clean Workshops in the Pharmaceutical Industry". Issues in the design of pharmaceutical clean rooms can also serve as valuable references for the design of sterile medical device clean rooms.


Temperature

The reason why temperature in clean rooms in summer exceeds the design range is often due to the initial determination of the air conditioning supply volume or air exchange frequency of each clean room, which only focuses on meeting the cleanliness index and neglects the verification calculation of the thermal balance of each clean room. Therefore, in the design and operation process of the production cleanroom, it is necessary to adjust the air conditioning supply parameters of the cleanroom in real time to ensure that the temperature of the production cleanroom is maintained at 18-28 ° C in all seasons. Temperature and relative humidity mainly affect the production process of products and the breeding conditions of bacteria, and can also affect the comfort of production operators on product quality.


Air supply volume, air exchange frequency

To determine the air supply volume for a medical device aseptic clean room at the design stage, firstly to meet the requirements of the corresponding cleanliness level of air changes times, but also based on the heat, humidity load calibration, to select the high-efficiency filters. Filter processing air volume should be less than or equal to the rated air volume, air filter resistance and efficiency should be close in the same clean area of high-efficiency (sub-high-efficiency, ultra-high-efficiency) .


Key Considerations:

  • Design and Construction: The design and construction of the sterile clean room must strictly adhere to relevant standards to ensure a controlled environment suitable for sterile medical device production. This includes selecting appropriate purification materials, considering air conditioning and purification systems, and ensuring proper static pressure differentials between cleanroom areas.

  • Monitoring: Regular monitoring of the clean room environment is crucial. This includes monitoring temperature, humidity, air changes per hour, static pressure difference, suspended particles, floating bacteria, and settling bacteria.  Deviations from specified parameters indicate a potential issue with the sterile environment. In the dynamic monitoring of sterile clean rooms, the main reasons for the change of the pressure difference between clean rooms are the flow of people, the insufficient fresh air volume and the frequent opening of doors. If the static pressure difference between clean rooms and the atmosphere or between clean rooms of different levels is in a critical state, it is likely that the pressure difference cannot meet the requirements due to the flow of people and the insufficient supply of fresh air during the dynamic detection.

  • Personnel and Operations:  Personnel working in the clean room can significantly impact the environment.  Strategies to minimize dust generation include wearing proper cleanroom garments, minimizing unnecessary movements, and using materials that produce fewer particles.

  • Site Selection:  The location of the clean room facility should be carefully chosen to minimize external sources of pollution, such as dust from traffic or industrial areas.


Clean Room Design Principles:

  • Layout: The clean room layout should optimize production flow, minimize cross-contamination, and ensure sufficient space for personnel and equipment. Different cleanroom areas should be arranged based on air cleanliness levels, with a flow from low to high cleanliness. Airlocks or other anti-pollution measures should separate cleanrooms with different levels.

  • Air Supply: The air supply system must meet the requirements for air changes per hour and fresh air volume as specified in GB 50457-2008. This ensures adequate dilution of contaminants and maintains a positive pressure environment.


The comprehensive performance verification before putting the clean room into operation is importance. This verification should encompass design, construction,  monitoring, and operational aspects. For in vitro diagnostic reagent production,  specific requirements apply to the handling of negative and positive serum samples.


By above guidelines and relevant standards, medical device manufacturers can ensure their sterile clean rooms meet the necessary requirements for producing high-quality sterile medical devices.

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