Verification of air purification system

Verification of air purification system Our company has participated in the validation of air purification systems for some large pharmaceutical companies both domestically and internationally. After decades of accumulation, a complete set of standard operating procedures has been formed to guide the implementation of verification, help improve the efficiency of verification, and successfully pass GMP verification. Any verification in the verification process requires joint collaboration among relevant departments, as well as unified procedures and standards, correct sampling and analysis methods.

Areas that require verification in controlled environments

AGrade sterile area (such as the canning area for sterile preparations)

BClass clean area (static)

CGrade Clean Area（BLevel dynamicsCStatic Level)

DGrade Clean Area（CLevel dynamics DGrade)

Verification of air purification system

The cleanliness of controlled environments is mainly maintained by air purification systems, so the validation of controlled environments begins with the validation of air purification systems.

The validation of air purification systems consists of several aspects, including preparation of testing instruments, installation confirmation, operation confirmation, cleanliness measurement (validation), etc,

The equipment involved in air purification systems mainly includes air handling equipment (air conditioning units), dehumidifiers, laminar flow hoods, clean workbenches, etc.

Documents and test reports required for the operation confirmation of air purification system

˜Operation and commissioning report of air conditioning unit

˜Temperature and humidity records of the room

˜Room pressure record

˜Report on Wind Speed and Airflow Direction of High Efficiency Filter

˜Pre inspection of suspended particles and microorganisms