- Implementation of Barrier Systems (Isolator/RABS) - Classification, Qualification & Monitoring of Clean Rooms
Target Group
This course is directed at staff in pharmaceutical engineering departments and production who are involved in the planning, qualification or operation of clean rooms. Engineering companies and GMP-planners are also the target group of this course.
Objectives
This course outlines the principles of planning, qualification and operation of clean rooms & barrier systems and their associated HVAC systems in the GMP environment. Both the protection concepts and the premises for aseptic and non-sterile manufacturing will be addressed. Also, classification according to ISO 14644-1 is part of the Programme.
Programme
GMP Requirements for Clean Rooms and HVAC Systems in the Pharmaceutical Industry
The EU GMP Guide, Annexes 1 and 15, ISO norms and other GMP-relevant guidelines
Definition of cleanliness: particles and microbiological limits
Comparison of EU and US requirements
Requirements during planning, construction and operation
Experiences from inspections
Zone Concepts
Consideration of the framework conditions: premises, number of floors, products, technologies
Estimation of the required spaces (with regards to the equipment and production capacities)
Requirements according to the different clean room zones
How to develop material and personnel flows: from process to layout
Planning with the technical room book
Specific pressure cascades and airlock requirements
Examples of zone concepts for sterile and non-sterile manufacturing including highly potent compounds
HVAC Systems: From Planning to Commissioning
Background for HVAC Systems
Design criteria
GMP criteria and requirements for recovery time, air changes, air velocity, differential pressures, …
Usage of flow visualisation tools
The different concepts possible from 100% fresh air to recirculation
Different production types and the influence on HVAC systems and their GMP relevance
Filters
Control strategies
Energy aspects
Requirements for the construction site
Monitoring systems
GMP Requirements for Clean Room Walls, Ceilings and Floors
Description of requirements coming from planning, ISO norms and GMP guidelines
Overview of the different wall and ceiling systems used in the pharmaceutical industry
Components of wall systems: terminals, doors and windows
The GMP-compliant clean room drain
Floors: Slip-resistance vs. GMP
Requirements for silicone joints (and coves)
Assignment of the different systems to the different clean room classes – which walls, ceilings and floors are appropriate/allowed for which cleanliness class?
Specifying the intended quality: the URS
How to determine the specified quality of walls, ceilings and floors
Barrier Systems
Definition of Isolator & RABS Systems
Pros & Cons of the different systems
Prerequisites for the use of isolators/RABS
Technical implementation of a barrier system
Particle Testing and ISO 14644
Leak testing of filters
Measuring overpressure and underpressure
Determination of the number of air changes
Measurement of the recovery time
Particle measurement and classification of the room
Requirements for particle counters
Number of measuring points and volumes according to ISO
Air flow study, smoke study (UDF)
Documentation of results
Qualification of Clean Rooms & HVAC Systems
Definitions: classification, qualification, requalification, monitoring and recurring tests
Organisation of the qualification of rooms and HVAC systems
Use and example of a risk analysis
Steps taken in URS, DQ, IQ, OQ, and PQ
Tests in the different qualification stages
Typical problems in the qualification of clean rooms and HVAC systems
Periodic requalification – which tests are really necessary?
Further Information
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) Non-ECA Members EUR 2,090 ECA Members EUR 1,890 APIC Members EUR 1,990 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
