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Independent Containment Performance Testing Of A ChargePoint® Split Butterfly Valve
ChargePoint split butterfly valves are designed to minimise the presence of potentially hazardous airborne particles during powder transfer operations within pharmaceutical manufacturing processes.
The industry has quantified the potential risk to the operating staff when handling these potent products. This measure is known as the product OEL ‘Occupational Exposure Limit' which is defined as he maximum allowable exposure over a given period of time and is expressed in µg/m³ (micrograms per cubic meter).
Split butterfly valve technology is one of various form of ‘containment' equipment that offer a solution to the protection of operators , fundamentally selected as a result of the required OEL of the product being handled. A typical split valve will achieve a containment performance of 1-10µg/m³, with more advanced systems, involving extraction, achieving even higher levels of performance.
In order to validate the performance of a split butterfly valve against the containment criteria, it has been necessary to perform surrogate powder transfer testing. The recommended procedure for containment performance testing is outlined in the ISPE Good Practice Guide, ‘Assessing the Particulate Containment Performance of Pharmaceutical Equipment' which was developed by the SMEPAC (Standardised Measurement of Equipment Particulate Airborne Concentration) Committee.
The guide covers the main factors that affect test results for specific contained solids handling systems, including material handled, room environment, air quality, ventilation and operator technique all based upon best practice within the industry.
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