Safeguarding Cell Quality: Annual Calibration of Environment and Equipment for Precision and Compliance

Shenyang Cell Center (SYCC) upholds stringent hygiene standards in alignment with AABB international guidelines. Maintaining a clean environment and reliable equipment are essential to the operation of a high-quality cell preparation lab. To ensure this, SYCC conducts annual assessments of both lab hygiene and equipment calibration. After each assessment, verification certificates are issued, confirming that all cells are prepared using certified equipment in a compliant lab environment.

 

On May 21–22, 2024, Guangdian Metrology and Testing Group Co., Ltd. conducted a comprehensive two-day inspection of Shenyang Cell Center’s environment and equipment. This verification is part of SYCC’s commitment to maintaining the highest standards for its cell preparation laboratory. The evaluation covered a wide range of equipment and environmental conditions to ensure strict compliance with GMP C+ and A-grade cleanliness standards.

 

The calibration process included thorough testing of the following:

• Cleanliness of all rooms in the preparation laboratory
• Biological safety cabinets
• CO2 incubators
• Refrigerators
• Centrifuges
• Infusion pumps
• Haier temperature monitoring probes
• Over 100 additional devices

 

Key environmental tests included monitoring:

• Room temperature
• Humidity levels
• Pressure differentials
• Air exchange rates
• Particle counts

 

These tests confirmed that the laboratory meets stringent cleanliness standards, ensuring that all conditions are conducive to high-quality cell preparation.

 

Additionally, specific equipment tests were carried out to guarantee the integrity and functionality of critical systems:

• Biological safety cabinets: Tested for HEPA filter integrity, airflow patterns, and overall cleanliness to ensure a sterile working environment for cell preparation.
• CO2 incubators: Evaluated for precise control of carbon dioxide concentration, temperature, and humidity, essential for maintaining optimal conditions for cell culture.

 

These meticulous assessments ensure that SYCC operates in full compliance with international standards, safeguarding the integrity of its cell preparation processes.

 

 

(Image: Testing the integrity of the HEPA filter in the biological safety cabinet)

 

(Image: Measuring airflow and air exchange rates at laboratory exhaust outlets)

 

(Image: Evaluating the integrity of laboratory environment HEPA filters)