Education Session

304 - Case Studies in Contained Active Pharmaceutical Ingredients (API) Pilot and Manufacturing Facilities

Get Agenda 10 November 08.15-11.30
ISPE CEUs: 0.23

Tracks: FacilitiesProductionQuality

This is sponsored by the ISPE Active Pharmaceutical Ingredients (API) and Containment Communities of Practice (COPs)

This session will address contained API pilot and small scale manufacturing facilities. Through case studies, participants will learn about:

  • Containment strategies
  • Exposure risk from equipment (Is the closed process closed?)
  • New build and retrofits
  • Rigid vs. flexible
  • Process innovations

How you will Benefit

At the end of this session, participants will be able to:

  • Understand the latest trends in API system design
  • Describe small scale API production systems (high value and potency) and therefore high hazard
  • Explain the trend to small scale continuous process
  • Discuss the issue of cost reduction and quality improvement

Who Should Attend

Engineers, process engineers, architects, and professionals in MEP, HVAC, operations, and API

ISPE Communities of Practice (COPs)

API, Containment, CU, Disposables, GCLP, HVAC, IP, OSD, PAT, PPD, PM, SPP, and SF

View the ISPE Community of Practice (COP) Guide

Session Leader

Session Presenters

Annual Meeting Sponsors