Containment Fundamentals

Milan, 8-9 October 2008

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

Instructor: Brian Ward, Ph.D., CCHEM, FRSC, CIH, Eli Lilly

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 organisations 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 Bulk Pharmaceutical Chemicals 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.

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
This Training Course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients (API), Containment (Containment), Disposables (Disposable), Heating, Ventilation, and Air Conditioning (HVAC), Project Management (PM), Oral Solid Dosages (In development), and Sterile Products Processing (SPP) Community of Practice (COP)


Training Programme General Information Venue and Area Information Sponsorship Opportunities Registration Information Download Brochure Current as of 28 May	Containment Fundamentals Milan, 8-9 October 2008 Intermediate Level ISPE CEUs: 1.3 Type: Classroom Training Course Instructor:* Brian Ward, Ph.D., CCHEM, FRSC, CIH, Eli Lilly 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 organisations 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 Bulk Pharmaceutical Chemicals 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. 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 This Training Course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients (API), Containment (Containment), Disposables (Disposable), Heating, Ventilation, and Air Conditioning (HVAC), Project Management (PM), Oral Solid Dosages (In development), and Sterile Products Processing (SPP) Community of Practice (COP)