Contamination Control Strategy
Blog post description.
CONTAMINATION CONTROL STRATEGY
Role of Air Filtration, direction, and differential pressure in contamination control
Facility design and layout play vital roles in Contamination control strategy (CCS). Faulty versions of the same have the potential to derail your best possible CCS. E.g.: The lack of physical barriers in ISO 5 areas can lead to potential contamination. Cross-contamination can be prevented by deploying appropriate levels of filtration, airflow direction, and pressure differential.
The selection of correct filters is critical for contamination control, and their effectiveness depends on their intended use and classification as per current international guidance (E.g., Most commonly used HEPA filters are capable of removing 99.97% of particles greater than 0.3 μm)
Always consider operator and equipment locations for airflow directions (perform adequate smoke studies under static and dynamic conditions to demonstrate airflow)
Based on risk assessment, the differential pressure and airflow direction should be designed to provide appropriate protection to the product, processing methods, operator, and environment
To prevent contamination and dust entry in the cleanroom, the differential pressure should be designed in a manner that can promote airflow direction from the higher clean area to the lower clean area.E.g.: Rooms of higher air cleanliness have a substantial positive differential pressure relative to adjacent rooms of lower air cleanliness
Limit differential pressure between adjacent areas so that there should be no risk of overlap in the operating region.
The differential pressure indication of a room should be provided by pressure gauges (must be tamperproof device) or suitable electronic systems such as Environmental Management System (EMS) or Building Management System (BMS). Ensure, pressure indication gauges are provided with acceptable range and graduation scale to bring accuracy in reading. In addition, alert and action limits should be defined and displayed at the point of indication or EMS/BMS.
The pressure control and monitoring devices used should be periodically checked and calibrated, to verify that specifications meeting as per compliance, and results must be recorded and maintained
An alarm system should be linked to Pressure control devices
Ensure tamper-proof zero setting of gauges which should be periodically checked
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Author
Ashutosh Mohan, Certified Six Sigma Black Belt, & cGMP
Founder & CEO, Consult MicroBio
Email: ashutosh@consultmicrobio.com