Clean Room System in Sterile Pharmaceutical

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
Headspace 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 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
Utility 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:

Air Sampling Frequency in Clean Rooms

Also see: Media Fill Validation Test in Sterile Pharmaceuticals