Sterile Drug Manufacturing Facilities

Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation - New Course!


Do You Know the Key Requirements and GMPs for Sterile Manufacturing Facilities?
This course uses the newly published second edition of the ISPE Baseline® Guide Sterile Manufacturing Facilities and the FDA's newly published Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Baseline® Guide provides valuable information on design, construction, and commissioning/qualification while the FDA's new Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing.

Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, basic utility systems, European HVAC considerations, basic commissioning and qualification issues, and a brief introduction to barrier isolation technology.
(Note: Parts of the FDA’s Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice that do not focus on facilities and equipment will not be discussed in detail.)

In addition, the course will include an exercise in the layout of an aseptic filling facility. In many cases, when a new facility is required within an existing or new building, the designer will begin by sketching a floor plan. This exercise will demonstrate how to use process flow diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage.

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Take Back to Your Job

  • Identify sources of contamination in aseptic operations
  • Explain methods for contamination control
  • Describe the major requirements for design, renovation, and operation of a sterile manufacturing facility
  • Discuss the fundamentals of aseptic clean room design
  • Understand the importance of monitoring critical parameters: temperature, humidity, air velocity, differential pressure, airflow patterns, non-viable particle counts, and microbial counts
  • Design a systematic process for aseptic facility layout
  • Apply ISO 14644, Clean Rooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness to Aseptic Processing Clean Rooms
  • Discuss the difference between U.S. and European clean room HVAC standards
  • Distinguish between the 2004 and 1987 versions of the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice as applied to the design, operation, maintenance, and modification of facilities

Attendance Recommended For

  • Engineers, validation scientists, quality assurance specialists, and manufacturing managers
  • Professionals who want a fundamental understanding of sterile manufacturing facilities and their design, renovation, and operation
  • Engineering firm professionals and other consultants who work with the pharmaceutical industry

    Immediately apply the course learning objectives using the complimentary copy of the ISPE Baseline Guide® Sterile Manufacturing Facilities (Second Edition).

Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Sterile (COP). For further information, visit
www.ISPE.org/COPs 

Instructor
Rob Walker is a chartered chemist and a fellow of the Royal Society of Chemistry with degrees in applied chemistry and instrumental analytical chemistry. He has more than 30 years of experience in the pharmaceutical industry including 25 years as a qualified person. After 16 years in senior management at CP Pharmaceuticals, the last seven as quality director, he is now a director of his own GMP consultancy company. Walker has comprehensive GMP manufacturing and quality experience covering a wide range of dosage forms and has successfully managed GMP inspections by MHRA and FDA.