ECA – Isolator Technology Workshop

You get an update on isolators for sterility testing and 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.

This course is part of the GMP Certification Programme “ECA Certified Sterile Production Manager”.

Objectives

Why should you attend this event?

• You get an update on isolators for aseptic manufacture and for sterility testing
• 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 both in sterility testing and in the production of sterile medicinal products, particularly in aseptic manufacture. 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“.

Target Group

This GMP Education Course addresses those employees from the pharmaceutical industry and from suppliers for aseptic (toxic) manufacture and for sterility testing involved in the engineering, validation and operation of these systems, especially from the areas

Engineering / Production
Quality Assurance
Qualification/ Validation
Microbiology

Program

Regulatory Requirements for Isolators for Aseptic Use

• Regulatory bodies
• US laws and regulations
• European laws and regulations
• Guidelines
• Basic Isolator definitions

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

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

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

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

Isolators used for Sterility Testing

• Requirements for the isolator
  • Background of the isolator
  • Performance Qualification
  • Qualification of operators
  • Test for gas-tightness of primary packaging materials
• Handling in isolator
  • Capacity
  • Testing the tightness of gloves
• Microbiological Monitoring
  • Sample plan
  • Contamination level
  • Contamination source
  • OOS/CAPA (example)

Isolators Used in Aseptic Fill Finish Manufacturing

• Isolator technologies in a parenteral production
• Preparation of an isolator used for aseptic filling
• Implementation of a new isolator
  • Design / Mock-up / From qualification to validation

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 H2O 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 EU Annex 1

• Handling in isolators
• Personnel at isolators
• RTP system
• Environmental monitoring in isolators
• Frequency of decontaminations
• Problems in isolators from the point of view of a user

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.