What is a Clean Room?
It’s a closed environment where “clean” or “aseptic” work is carried out.It has a “regulated” atmosphere
It has low particle count with “predefined limits”
It is designed to generate less particles
It is designed to remove generated particles
Why Clean Room?
To protect the Product from contaminants
Head space is a portion of the Clean Room environment.
Contaminants:
What contaminants should be kept out?
Physical- dust, dirt, fibre, grit, glass, lint,
Chemical- organic, inorganic, vapours, fumes, smoke
Biological- bacteria, fungi, virus, spores, pollen, endotoxins, human cells
Energies- heat, light, sound, static, magnetic, electricity, radiation
Sources of contamination - All inputs to the “Clean Room” are sources of contamination
Material- RM, PM, lubricants, cleaning agents, disinfectants
Machines- wear & tear of moving parts, rust, peel-off, emissions
People- sweat, breath, saliva, hair, cells,
Air- can bring in anything and everything imaginable
Facility- shedding, wear & tear, breach
GMP design philosophy
Knowledge is not a single person’s domain
Architectural/facility engineering
Process engineering
Basic engineering – mechanical, electrical, civil, electronics, instrumentation
R&D – process development & scale-up know how.
QA/QC – limits, controls & validation
Regulatory
Design information
User requirement specifications including regulatory requirements
Process description
Material & personnel flow diagrams
General arrangement drawings, room layouts
Process & instrumentation diagrams (P&ID)
HVAC basic layouts, specifications and area classification drawings
Utilities list with specifications
Control system design specifications
GMP design issues
Process issues
Layout issues
Automation strategy issues
Flow issues
Regulatory issues
Validation strategy issues
Clean Room Classification Limits: