Containment Fundamentals (T16)

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

Date Location Country Instructor(s)
This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.

Description

In today's world of advanced medications, potent compounds are playing an increasingly prominent role in fighting illness and disease. While benefits to patients are great, the potential adverse effects to healthy individuals working with these compounds are numerous. Just as important, quality organizations within companies are embracing good manufacturing practices (GMPs) for satisfactory containment of processes on the production floor, thus reducing or eliminating the potential for cross-contamination. Other project goals are the business and environmental benefits related to reducing production costs, and limiting the impact to the outdoor environment.

This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and processes. An exploration of different containment philosophies, methods of source containment, and a hierarchy of containment approaches will also be covered. After establishing the need for containment and presenting alternative methods, the course will focus on the importance of fully understanding a manufacturing process in all its dimensions (physical hardware, remedial containment provisions, facility considerations, operator interface, cleaning and decontamination, and other aspects) before optimal containment solutions may be incorporated. This course will address plant operations ranging from pilot scale to commercial manufacturing.

The general principles and approaches presented in the course will be compatible with the new containment chapter of ISPE's Active Pharmaceutical Ingredients Baseline® Guide. Principles and approaches presented will be applicable to both bulk and secondary pharmaceutical manufacturing operations. Participants can expect open class discussions, sample problems, and an analysis of case studies.

Course Modules

  • Definitions
  • History
  • Fundamental Concepts
  • Modes of Containment
  • Risk Assessment
  • Application
  • Class Exercise
  • Putting It All Together

Take Back to Your Job

  • Define key terminology used when discussing containment
  • Identify rationales for effective containment
  • Discuss the difficulty of preventing substances from being distributed throughout the environment
  • Cite a hierarchy of containment approaches
  • Understand fundamental containment technologies
  • Explain the importance of understanding a process before applying containment principles
  • Describe principles for maintaining and controlling a contained environment
  • Discuss methods for evaluation of containment performance, including ISPE's Good Practice Guide on Assessing the Particulate Containment Performance of Pharmaceutical Equipment

Attendance Suggested For

  • Professionals who need knowledge of fundamental containment principles, such as facilities and process development engineers, regulatory compliance and quality assurance specialists, safety and industrial hygiene personnel, and operations and manufacturing managers
  • Engineering professionals and other consultants who work with the pharmaceutical industry

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.

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