Skip to main content

CLEAN ROOM SYSTEM IN STERIL PHARMA

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 disinfectant
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:


     AIR SAMPLING FREQUENCY IN CLEAN ROOMS




Labels:

Popular posts from this blog

Disintegration Time for tablets as per IP, BP and USP

Disintegration Time:- Uncoated Tablet NMT 15 min, in water with Disc 37 0 C ± 2 0 C Coated Tablet NMT 30 min, In water with Disc for Film Coated Tab , and NMT 60 min Other than Film coated tablet Enteric Coated Tab Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid. Dispersible/Soluble Within 3 min in water at 25 0 C ± 1 0 C ( IP ) & 15 – 25 0 C ( BP ) Orodispersible Within 1 min Effervescent Tab 5 min in 250 ml water at 20 – 30 0 C ( IP ) & 5  min in 200 ml water at 15-25 0 C ( BP ) Buccal & Sublingual Not Applicable but dissolve within 15 – 30 min. DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from bottom & top, Temp of water 37 0 C ± 2 0 C. If 1 or 2 tabs fail, repeat for 12 tabs. Click to Buy Here
Read more

Weight variation limit for tablet and capsule.

Weight Variation Limits:- 1) For Tablets  IP/BP.                           Limit.                          USP 80 mg or less.             10%                     130mg or less  80 mg to 250mg.       7.5%               130mg to 324mg 250mg or more.          5%               More than 324mg 2) For Capsule:- IP Limit Less than 300mg 10% 300mg or More 7.5%
Read more

Basics and use of HVAC system in pharma

HVAC is an essential aspect in pharmaceutical industry as factors like temperature, relative humidity and ventilation have a direct impact on the quality of the pharmaceutical product. The designing of the HVAC should be sorted out while design concept of facility is in progress as it is linked to the architectural layouts like air locks, doorways and lobbies. Once the HVAC system is properly designed and installed it not only helps to create the required room pressure differential cascades but also prevents the cross contamination. Basically an HVAC system works by transferring the heat and moisture into and out of the air and controls the level of the air pollutant either by removing them or diluting them to a particular level. TECHNOLOGY OVERVIEW: HVAC system varies according to the size and installation capacity within a facility but the basic components remain almost the same. LAYOUT OF A TYPICAL BASIC HVAC SYSTEM HEATING SYSTEM: The heat source is either a furnace or ...
Read more