•  The EU GMP guide, Annex 1 and 15, ISO Norms and other GMP relevant guidelines
•  Definition of cleanliness: particles and microbiological limits
•  Comparison of EU und US requirements
•  Requirements during planning, construction and operation
•  Experiences from inspections

•  Considering of the frame 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 personal flows: from process to layout
•  Planning with the technical room book
•  Specific pressures cascades and airlock requirements
•  Examples for zone concepts for sterile and non-sterile manufacturing including highly potent compounds

•  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

•  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

• Definition of Isolator & RABS Systems
• Pros & Cons of the different Systems
• Prerequisites for the usage of isolator/RABS
• Technical implementation of a barrier system

•  Leak testing of filters
•  Measuring over and under pressure
•  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

•  Definitions: classification, qualification, requalification, monitoring and recurring tests
•  Organisation of the qualification of rooms and HVAC systems
•  Usage and example of a risk analysis
•  Steps taken in URS, DQ, IQ, OQ, and PQ
•  Tests in the different qualification stages
•  Typical problems in clean room and HVAC systems qualification

Case Study Boehringer Ingelheim: Implementation of the Clean Room Requirements of EU GMP Annex 1