Facility Design for API Development
January 19, 2016
The development of APIs (active pharmaceutical ingredients) is a lengthy and costly process. To ensure the proper design, construction and operation of facilities, systems and infrastructure to support API development, the following must be carefully considered:
- Containment and Control Strategies: Closed system processes, liquid vs. powder processes, contained pneumatic conveying, material transfer controls such as isolators with rapid transfer ports (RTP), downflow booths, gloveboxes and glovebags and PPE to protect personnel from exposure to API chemicals
- Reactors: Reactor materials of construction (all glass, glass-lined carbon or stainless steel, Type 316L SS or Hastelloy C), operating pressures, safety, heat transfer, agitation and cleaning
- Separation Equipment: Vacuum distillation, liquid-liquid extraction and centrifuge systems
- Drying Equipment: Tray dryer and filter dryer systems
- Pollution and Waste Control: Dust control, scrubbers, carbon adsorption, isolation/neutralization tanks
- Process Utilities: Water (city or USP/point-of-use, loop or bulk raw material), compressed air, gases (compressed gas cylinders, liquid-filled Dewar bottles), vacuum (liquid-ring, once-through oil and dry vacuum pumps), heat-transfer media (reactors equipped with temperature control modules (TCM), heat exchanger and pump)
- Facility Layout and Design: Unidirectional personnel/material flows to avoid cross contamination, utility access, materials of construction, interior finishes, cGMP, cleanability and maintenance and ergonomics
- Environmental Conditions: cGMP/containment required air changes and pressurization, ISO classification, recirculation vs. once-through air
- Electrical Classification: Class 1, Div. 1 or 2 or Class 2, Div. 1 or 2
EIA’s in-depth pharmaceutical processing and design experience provides a strong knowledge base. Our in-house team of pharmaceutical facility specialists includes the significant API facility expertise of Mr. Yasha Zelmanovich, EIA’s Process Engineering Manager. Yasha has over 30 years of process pharmaceutical experience and has co-authored “Designing a Facility for API Development”, published in CEP magazine. Please click here for a full copy of Yasha’s article.
Let EIA’s in-house team of pharmaceutical facility specialists assist you with your next project.