Sterile Drug Manufacturing Facilities:

Applying ISPE Baseline® Guide and USFDA Guidance Principles to Design and Operation

Wednesday 22 September - Thursday 23 September

Course Content Level: Intermediate

Instructor: Diana Knittel-Pace

This course references ISPE's Sterile Manufacturing Facilities Baseline® Guide and the USFDA's newly published Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice. Both of these documents help provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Baseline Guide provides valuable information on design, construction, and commissioning and 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 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 diagrammes and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage. 

Participants will receive a complimentary copy of the Sterile Manufacturing Facilities Baseline® Guide.

Who Should Attend:

  • 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

Community of Practice (COP):

Sterile Products Processing

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

Instructor Biography:

Diana Knittel-Pace is an independent consultant with more than 22 years of experience in the pharmaceutical manufacturing industry. As president of Outsource, Inc., her area of expertise is facilities and engineering, with particular emphasis on qualification, calibration, maintenance and engineering. In the early part of her career, Knittel-Pace worked on staff for Pfizer and Marion Laboratories. Since 1991, she has worked as a consultant on projects for companies throughout the United States and Puerto Rico, as well as France and Canada. For the last five years, she has worked exclusively with The Quantic Group LTD, on projects involving consent decree, warning letter, and 483 issues at both corporate and site levels.
Knittel-Pace received her MBA from the University of Kansas in 1991 and her BS degree in Chemical Engineering from the University of Missouri in 1981. She has served on the ISPE International Board of Directors, is a Past President of the ISPE Midwest Chapter, and has served as chairperson and member of multiple ISPE committees.