High-Potency APIs: Containment and Handling Issues - Pharmaceutical Technology

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High-Potency APIs: Containment and Handling Issues
The author explains the planning, equipment, and facility design requried for manufacturing HPAPIs and specialized requirements for handling these compounds.

Pharmaceutical Technology

Third-party certification. Companies handling HPAPIs should also consider being certified by a third-party organization such as SafeBridge. This certification process allows for all aspects of the potent compound-handling program to be evaluated against current industry expectations by independent experts. As an added benefit, certification can also lead to continuous improvement and evaluation programs designed to ensure advancement of the HPAPI-handling systems. Even if the company chooses not to go through the certification process, they still may choose to have an evaluation by third-party experts as an effective means of identifying gaps or opportunities for improvement in the HPAPI program.


The development and manufacture of high-potency active pharmaceutical ingredients (HPAPIs) requires significant planning, extensive employee training, proper equipment, and facility design as well as implementation of the necessary procedures to safely handle the compounds. The capital investments are significant, and the knowledge gained through experience is invaluable. Robust systems must be employed in all aspects of the HPAPI-handling program, from initial project evaluation through equipment cleaning, to disposal of process wastes. As the number of potent compounds in pharmaceutical development continues to increase, so will the opportunities for HPAPI manufacturers, especially for companies with capabilities in growing niche areas such as HPAPI–antibody conjugation.

David Bormett is director of regulatory affairs at SAFC Pharma, 645 Science Drive, Madison, WI 53711, tel. 608.233.3115, fax 608.233.6873,


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2. A. Thayer, "Contained Chemistry," C&EN, 86 (24), 17–27 (2008).

3. P. Van Arnun, "Investing in High-Potency Manufacturing," Pharm. Technol. 31 (11), 54–58 (2008)

4. A.W. Ader, J.J. Mason, and J.P. Farris, "Important Elements in Evaluating Contract Manufacturing Organizations," Chem. Today 25 (2), 56–60 (2007).

5. B.D. Naumannet et al., "Performance-Based Exposure Control Limits for Pharmaceutical Active Ingredients," Amer. Indust. Hyg. Jour. 57 (1) 33–42 (1996).


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