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HIGH POTENCY PROCESSING • System based evaluation of every API for exposure potential • Process risk assessment to define containment strategy and PPE • Mitigation strategies to address potency challenges • In house engineered isolation technology solutions Pg 1 SOLID ORAL DOSAGE FORMS ALMAC PROCESSES HIGH POTENCY APIs IN DRUG PRODUCT DEVELOPMENT, CLINICAL TRIAL SUPPLY AND SMALL VOLUME COMMERCIAL PRODUCTS HEALTH AND SAFETY APPROACH Almac develops and manufactures solid oral dosage formulations containing high potency API from our non-GMP and GMP facilities, with batch sizes ranging from milligrams up to 100 kg. Before any processing begins, Almac will assess the health and safety implications of an API. The molecule’s OEL (occupational exposure limit) is used to assign it to one of five bands. The assigned band is then used as part of a detailed process risk assessment. Where appropriate, Almac can use a range of proven engineering controls to minimise exposure potential during transfer and processing. Examples of engineering controls include: • • • • • • Ventilated enclosures Isolators Enclosed gravity feed systems Split butterfly valve systems Enclosed vacuum transfer systems EZ-dock valve systems ALMAC ROUTINELY PROCESSES COMPOUNDS WITH OELs AS LOW AS 0.05 μg/m3/8 HOURS Almac also performs a separate, health-based risk assessment to minimize potential product cross contamination. Almac uses either the PDE (permitted daily exposure) or ADE (acceptable daily exposure) to set cleaning validation and cross contamination limits. Cleaning limits consider a number of factors including dose of the drug in the next batch, total product contact surface of the equipment and minimum batch size. We can perform the following processes on high potent material: Blending, compression, coating, encapsulation, roller compaction and HSG/FBD. We are dedicated to providing safe, high potency processing for our clients. GET IN TOUCH www.almacgroup.com UK Almac Group (Global Headquarters) 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom US Almac Group 2661 Audubon Road Audubon, PA 19403 United States of America [email protected] +44 28 3836 3363 [email protected] +1 610 666 9500 AM6669
