Dr Lars Kreye
Boehringer Ingelheim
Referierende
Andreas Nuhn
D&B Pharmadesign
Nikolaus Ferstl
Facility Engineering Services
Dr Jean-Denis Mallet
Former Head of the French Inspection Dpt.
André Lourenco
Novo Nordisk
Highlights
- Zone Concepts for Sterile, Non-sterile and Highly Potent Products
- Zone Concepts for Sterile, Non-sterile and Highly Potent Products
- HVAC Components & Concepts
- GMP-compliant Clean Room Walls, Ceilings and Floors
- GMP-compliant Clean Room Walls, Ceilings and Floors
- Implementation of Barrier Systems (Isolator/RABS)
- Classification, Qualification & Monitoring of Clean Rooms
- Classification, Qualification & Monitoring of Clean Rooms
Zielgruppe
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.
Zielsetzung
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.
Programm
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?
Weitere Informationen
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.
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.
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.
The official conference language will be English.
Contacts
Qestions regarding content:
Dr Robert Eicher , +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Dr Robert Eicher , +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 9 March 2027, 09:00-16:45 h
Wed, 10 March 2027, 09:00-16:15 h
Wed, 10 March 2027, 09:00-16:15 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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