You get an technological update on isolators for aseptic manufacture
You get to know the results of recent studies on the validation of isolators
You have the opportunity to discuss your individual questions personally with experts
You can translate the theory directly into practice during 3 workshops at the manufacturing site of Skan in Allschwil
Each participant takes part in all 3 workshops. The workshops are held at the plant of SKAN AG, partly including operational isolators. This brings the participants as close to daily practice as possible.
Background
The use of isolators is increasing in the manufacturing of sterile medicinal products, particularly in aseptic manufacture, and in the handling of toxic / high potent APIs. It ensures a greater microbiological safety of the products, but at the same time requires increased inputs as regards the qualification of these systems and the validation of the production processes.
In 2004, Appendix 1 to the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“ defined new regulatory requirements on using this technology, as did the PIC/S document PI 014-3 „Isolators used for Aseptic Processing and Sterility Testing“ and the expected revision of EU GMP Annex 1.
Target Group
This GMP Education Course addresses those employees from the pharmaceutical industry and from suppliers / Contract organisations involved in the engineering, validation and operation of Aseptic (toxic) Manufacturing Isolators, especially from the Areas Engineering / Production, Quality Assurance, Qualification/ Validation, Microbiology. The number of participants is limited.
Please understand that, for competitive reasons, not all firms can register their employees for this event.
Regulatory Requirements for Isolators for Aseptic Use
Regulatory bodies
US laws and regulations
European laws and regulations
Guidelines
Basic Isolator definitions
Annex 1 - Risk Analysis and Consideration of Transfer Material and Environmental Monitoring
Contamination Control Strategy & Quality Risk
Management Principles
Environmental monitoring program
Gloves/Sleeves management program
Transfer materials & personnel interventions
Aseptic processing validation management
Isolator Application / Projects: From the Conceptual Design to the Validated Equipment incl. Mock-Up Study
Key decisions
What do we need from our customers?
From URS to engineering – technical details and solutions
Process challenges and features
FAT – Installation – Qualification
Purpose of mock-up
What is required before starting a mock-up
How to document a mock-up
What simulations need to be included in the mock-up
Execution of the mock-up itself
Examples for our mock-up to underline the points above
Bioindicators / Process Development of Isolator Decontamination
Overview of current regulations and standards
Basis and selection of suitable biological indicators as sensor for the inactivation effect
Development and quantification of decontamination cycles
Influence of H2O2 to routine processes
Isolator and Associated Technologies
Isolator technology in GSK Bio
Applications for bulk
Applications for formulation
Applications for filling processes
Sterility testing
Case Study Merck: New Aseptic Filling Building: A Quality by Design Approach
Presentation of the project
Business case construction
Compliance requirements
QBD approach and implementation
Product Tech Transfer strategy
ASTME2500 qualification and validation strategy
Troubleshooting in Isolator Technology
The place of the isolator in a pharmaceutical process
The influence of critical parameters on the decontamination process
The reliability and reproducibility of biological indicators
The expectations of regulators
Aseptic Filling Isolators from a Microbiological Point of View
Environmental monitoring
Media Fills
Sterility tests
Integrity of gloves and sleeves
Validation studies
OOS results in isolators
Workshop Session
Workshop 1:
Validation Planning for an Aseptic Isolator
Test master plan (IQ/OQ)
IQ / OQ test protocols
Operational qualification - procedures
Handling of deviations
Performance of Selected Qualification Tests
Basic SOP for testing
Execution of tests
Generate test records
Drawing up the test report
Glove testing
Glove Integrity Testing
Regulatory Background
Physical methods for glove integrity tests and their boundaries
Microbiological contamination risk
Routine program for glove integrity testing
Workshop 2:
Development and Quantification of H2O2 Decontamination Cycles
Establish the requirements of a decontamination cycle
Design a qualification strategy
Work out the necessary physical and microbiological tests and their chronology
Interpretation of test results and reaction on deviations
Write a transparent qualification Report
Workshop including a real isolator system
Workshop 3:
Isolators according to EU Annex 1
Handling in isolators
Personnel at isolators
RTP system
Environmental monitoring in isolators
Frequency of decontaminations
Problems in isolators from a users‘ point of view
You will take part in all Workshops!
The workshops will take place at SKAN AG in Allschwil.
After the workshops, at appr. 16.15 h, a bus shuttle service will bring the participants to the airport (appr. 16.35 h), the German train station (appr. 16.50 h), the Swiss train station (appr. 17.15 h) or the hotel. (appr. 17.15 h) or the Hotel.
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager" Learn more
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Testimonials
Seminar Programme as PDF