Clean rooms




Design Risk Analysis
Guideline Requirements


Cross Contamination Prevention
Containment technology
Books and presentations




  Title Download
Good Engineering Practice GEP
Design of pharmaceutical sites and process validation
Engineers Guide to Pharmaceuticals Production
Building Design and Construction Handbook
Premises. Official requirements  
Premises. General requirements
Location, connection to other rooms
Size, area, height
Installation and supply of utilities
Lighting, ventilation, air-conditioning
Hygienic construction
Room book and layout
Material flow, personnel flow and layout  
Room classes  
Construction elements  
Heating Ventilation Air Conditioning (HVAC)
 - Pure (100%) external air conditioning system
 - Central recirculating air/mixed air conditioning system
 - Decentralised recirculating air/mixed air conditioning system with central external air preparation
 - Pure recirculating air conditioning system
 - Systems for tempering and volume flow regulation
 - Control-systems of the air volume flows
 - Utilities for the operation of room ventilation systems
Principles for the design and planning of air conditioning ventilation systems
Design criteria for the ventilation of premises
Maintenance of air ventilation systems
Qualification of air conditioning ventilation systems
Facilities and Equipment  
Facility concepts
CIP (Cleaning in Place)
Isolator technology
Connected facilities
Examples of facility qualification
Design qualification
Installation qualification
Operational qualification
Technical documentation  
CIP (Cleaning in Place)  
Containment (personnel protection) in solids handling  
Process control systems  
Hygienic (sanitary) design when using solids  
Cleanroom Design