Sterile Product Manufacturing Facilities: Applying the new ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)

Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course

Description

This course uses the newly published second edition of the ISPE Baseline^® Guide: Sterile Product 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 Guide provides valuable information on design and while the USFDA'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, 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 diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage.

Course Modules

• Concepts and Regulatory Philosophy
• Process and Equipment Considerations
• Architecture and Layout
• HVAC
• Utility Systems
• Electrical services
• Control & Instrumentation
• Cleaning: Engineering Issues
• Barrier-Isolator Technology
• General Considerations
• Exercises
• Supplemental Materials

Take Back Your Job

• Understand the regulatory impact on design, construction, and the regulatory context and expectations for sterile drug manufacturing including the use of RABS and isolator systems
• 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 Suggested For

NOTE: Participants interested in commissioning and qualification should attend the Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification training course.

• 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

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment: Design and Construction / Installation and Production Systems: Production Control. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Sterile Products Processing (COP).