What is a Clean Room?
It’s a closed environment where “clean” or “aseptic” work is carried out.It has a “regulated” atmosphereIt 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 contaminantsHeadspace is a portion of the Clean Room environment.
Related: Clean Rooms and Controlled Areas (Sterile Area Classification)
Contaminants:
What contaminants should be kept out?
Physical- dust, dirt, fiber, grit, glass, lint,Chemical- organic, inorganic, vapors, 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
Related: Sanitation of Cleanroom Area in Pharmaceutical Manufacturing
GMP design philosophy
Knowledge is not a single person’s domainArchitectural/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 requirementsProcess description
Material & personnel flow diagrams
General arrangement drawings, room layouts
Process & instrumentation diagrams (P&ID)
HVAC basic layouts, specifications and area classification drawings
Utility list with specifications
Control system design specifications
GMP design issues
Process issuesLayout issues
Automation strategy issues
Flow issues
Regulatory issues
Validation strategy issues
Clean Room Classification Limits:
Air Sampling Frequency in Clean Rooms
nice information about Cleanroom room system
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