Clean Room System in Sterile Pharmaceutical

Know about Clean Room, source of contamination, removal of contamination and Air Sampling Frequency in Clean Rooms

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: C lean 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: S anitation 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