Handling HPAPIs for maximum manufacturing flexibility while maintaining adequate safety controls
Samuel Baron , R & D director at SK Biotek Ireland , and William DuBay , VP of global R & D at SK Pharmteco , share some experiences
Through continuous improvement in the fields of containment and risk management , the ability to scale-up and manufacture HPAPIs and their intermediates continues to develop . A well-established safety management system for HPAPIs can lead to increased flexibility in manufacturing and R & D capabilities . A robust safety management of HPAPIs is paramount . The approach to safety at SK Pharmteco is to classify and control highly potent compounds , including HPAPIs used on site , using a risk-based approach to ensure appropriate controls are in place , commensurate to the hazardous nature of the chemical .
Key aspects of a robust safety management approach include a well-defined banding system for air concentration of substances across many bandwidths . SK Pharmteco uses a six-band system , each corresponding to a different level of containment controls required to appropriately contain the compound ( Figure 1 ). Compounds with OELs of < 10 ยต g / m 3 ( Bands 4 , 5 and 5 Special Case in our system ) are considered to be HPAPIs We also use a tiered approach for exposure controls , ranging from elimination of hazards to administrative controls . The core elements to controlling the hazards are process , facility and administrative design so as to rely on primary protection with engineered controls and minimally on administrative controls and personal protective equipment ( PPE ). The aim here is to control the contamination at the source to below specified levels by primary containment . Secondary containment ( e . g . facility design , including HVAC design ) supplements primary containment and prevents the risk of contaminating the external environment .
IH monitoring
To supplement containment design , a robust industrial hygiene ( IH ) monitoring programme must be in place . This should encompass the full lifecycle of a piece of equipment from
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