AFMS that offer certification of cleanrooms and clean spaces according to standards and guidelines such as ISO14644, GMP (Good Manufacturing Practice), and AHSRAE (American Society of Heating, Refrigerating, and Air-Conditioning Engineers) play a crucial role in ensuring the cleanliness, compliance, and quality of controlled environments. These services follow recognized industry standards to validate and certify the performance of cleanrooms and clean spaces.
ISO14644 is an international standard that provides specifications and classifications for cleanrooms based on the concentration of airborne particles. GMP is a set of guidelines that ensures the quality, safety, and consistency of products in regulated industries such as pharmaceuticals, biotechnology, and healthcare. AHSRAE standards focus on energy efficiency and environmental conditions related to heating, ventilation, and air conditioning systems.
Certification services for cleanrooms and clean spaces follow a comprehensive approach, encompassing various aspects to ensure compliance with these standards and guidelines. Some key steps involved in the certification process include:
Key Step for Certification
Particle Counting and Classification:
Certification services perform particle counting using calibrated instruments to measure the concentration and size distribution of airborne particles within the cleanroom. The results are compared against the ISO14644 classification requirements to determine the cleanliness level of the cleanroom.
Airflow and Air Exchange Rate Measurement
Airflow velocity and air exchange rates are measured to verify that the cleanroom meets the required specifications. These measurements ensure that the air circulation is adequate to maintain the desired cleanliness level and prevent the accumulation of contaminants.
Filter Integrity Testing:
Certification services conduct integrity testing of the air filtration systems, such as HEPA (High-Efficiency Particulate Air) filters, to ensure they are free from leaks or defects. This testing is crucial to ensure that the filters are functioning properly and effectively capturing airborne particles as per the defined standards.
HVAC System Assessment:
The HVAC system is evaluated to assess its performance in maintaining the desired environmental conditions, including temperature, humidity, and air quality. Certification services examine the system's design, operation, and maintenance practices to ensure compliance with GMP and AHSRAE guidelines.
Documentation and Record Review:
The certification process involves a thorough review of documentation, including standard operating procedures, maintenance records, and calibration logs. This ensures that proper protocols have been followed, and the cleanroom has been maintained in accordance with the relevant standards and guidelines.
Particle Counting and Classification:
Certification services perform particle counting using calibrated instruments to measure the concentration and size distribution of airborne particles within the cleanroom. The results are compared against the ISO14644 classification requirements to determine the cleanliness level of the cleanroom.
Particle Counting and Classification:
Certification services perform particle counting using calibrated instruments to measure the concentration and size distribution of airborne particles within the cleanroom. The results are compared against the ISO14644 classification requirements to determine the cleanliness level of the cleanroom.
Airflow and Air Exchange Rate Measurement:
Airflow velocity and air exchange rates are measured to verify that the cleanroom meets the required specifications. These measurements ensure that the air circulation is adequate to maintain the desired cleanliness level and prevent the accumulation of contaminants.
Filter Integrity Testing:
Certification services conduct integrity testing of the air filtration systems, such as HEPA (High-Efficiency Particulate Air) filters, to ensure they are free from leaks or defects. This testing is crucial to ensure that the filters are functioning properly and effectively capturing airborne particles as per the defined standards.
HVAC System Assessment:
The HVAC system is evaluated to assess its performance in maintaining the desired environmental conditions, including temperature, humidity, and air quality. Certification services examine the system's design, operation, and maintenance practices to ensure compliance with GMP and AHSRAE guidelines.
Documentation and Record Review:
The certification process involves a thorough review of documentation, including standard operating procedures, maintenance records, and calibration logs. This ensures that proper protocols have been followed, and the cleanroom has been maintained in accordance with the relevant standards and guidelines.
Certification of cleanrooms and clean spaces based on ISO14644, GMP, and AHSRAE guidelines provides assurance that the controlled environments meet the necessary cleanliness, safety, and quality standards. It demonstrates compliance with industry regulations and requirements, and instills confidence in customers, regulatory agencies, and stakeholders regarding the reliability and integrity of the cleanroom facilities.
AFMS that offer cleanroom certification play a vital role in helping organizations identify any deficiencies, implement corrective actions, and maintain the cleanliness and performance of cleanrooms. Regular certification and adherence to these standards and guidelines are essential to ensure ongoing compliance, optimize operational efficiency, and safeguard product quality in industries where controlled environments are critical.