Drugdu.com expert's response:

The self-testing laboratories for IVD (In Vitro Diagnostic) products have a series of specific requirements in terms of environment and facilities, which aim to ensure the safety, accuracy, and compliance of the laboratories. Below is a detailed summary of these requirements:

I. Environmental Requirements

Cleanliness: The cleanliness of the laboratory must meet the ISO 14644-1 standard, typically ISO 7 or ISO 8 class, to reduce particulate and microbial contamination. This helps ensure the accuracy and reliability of experimental results.

Temperature and Humidity Control: The temperature is generally controlled between 20-25°C, and humidity between 30%-60%. Stable temperature and humidity conditions contribute to the normal operation of experimental equipment and the stability of experimental results.

Biosafety: Depending on the type of experiments, the laboratory must comply with BSL-1 or BSL-2 (Biosafety Level Laboratory) standards. This includes setting up biosafety cabinets, installing HEPA filters, and other measures to prevent contamination of biological samples and exposure of personnel.

II. Facility Requirements

Separation of Experimental and Auxiliary Areas: The laboratory should clearly divide the experimental area, office area, storage area, etc., to avoid cross-contamination. The experimental area is the main area for experimental operations and should maintain a high level of cleanliness and sterility.

Separation of Personnel and Material Flow: Separate channels for personnel and materials entering and exiting the laboratory should be established to reduce the risk of contamination. This helps maintain the cleanliness and safety of the laboratory.

Specialized Equipment: The laboratory should be equipped with precision instruments and specialized equipment, such as PCR machines, ELISA readers, centrifuges, refrigerators, ultra-low temperature freezers, etc., to ensure the safe storage and accurate detection of samples and reagents.

Biological Waste Disposal: The laboratory should dispose of biological waste according to biosafety standards, using dedicated containers and sterilization equipment. This helps prevent biological contamination and cross-infection.

Chemical Waste Disposal: Chemical waste should be collected separately and disposed of by professional agencies. This helps protect the environment and personnel safety.

Emergency Facilities: The laboratory should be equipped with emergency equipment such as eye wash stations, emergency showers, fire extinguishers, etc., to respond to emergencies. These devices should be regularly inspected and maintained to ensure they are in good condition.

Personal Protection: The laboratory should provide protective clothing, gloves, masks, goggles, and other protective equipment to protect the safety and health of laboratory personnel.

III. Other Requirements

Data Recording and Data Security: The laboratory should use electronic or paper records to ensure data traceability. At the same time, measures should be taken to protect data security and prevent leaks.

Certification and Audits: The laboratory should comply with quality management system requirements such as ISO 13485 and GMP, and undergo regular internal and external audits to ensure compliance with regulations and standards.

Professional Training and Continuous Education: Laboratory personnel should receive training in biosafety, equipment operation, etc., and regularly update their knowledge and skills to ensure proper operation.

In summary, the self-testing laboratories for IVD products have strict requirements in terms of environment and facilities. These requirements aim to ensure the safety, accuracy, and compliance of the laboratories, thereby guaranteeing the quality and reliability of IVD products.