Clean Rooms & HVAC Systems - GMP requirements for planning, qualification & operation

07.05.2019 - 08.05.2019
Vienna, Austria


GMP requirements for clean rooms and HVAC systems in the pharmaceutical industry

  • 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

Zone concepts

  • 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

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 rooms 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 usage of isolator/RABS
  • Technical implementation of a barrier system

Particle testing and the ISO 14644

  • 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

Qualification of clean room & HVAC system

  • 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
  • Periodic requalification – which tests are really necessary?

Operation of clean rooms / barrier systems

  • Recurring particle measurements
  • Routine microbiological monitoring
  • Tests for isolators
  • What to do for maintenance?
  • Cleaning
  • Requalification
  • Trending of data, evaluation, the PQR

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