Clean rooms

 

 

 

	Design Risk Analysis
	Guideline Requirements
	Engineering
	HVAC
	Qualification
	Monitoring
	Maintenance

 

	Cross Contamination Prevention
	Containment technology
	Aspiration
	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 Filters 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
	Control
	Facility concepts CIP (Cleaning in Place) Isolator technology Connected facilities
	Examples of facility qualification Design qualification Installation qualification Operational qualification
	Technical documentation
	Calibration
	Maintenance
	CIP (Cleaning in Place)
	Containment (personnel protection) in solids handling
	Process control systems
	Hygienic (sanitary) design when using solids
	Cleanroom Design