What’s Clean room?
An area/room which is designed, constructed, used and
maintained in such a manner, so as to preclude or reduce
the introduction, generation or retention of viable and non-
viable particulates.
Clean room is regulated and monitored for RH,Temp &
∆P.
What’s Quality?
• Meeting the predetermined requirements of the user for a
particular product or service.
• Totality of characteristics of an entity that bear on its ability
to fulfil implied or stated needs.
What’s GMP?
GMP is that part of QA, which ensures that the products are
consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the
marketing authorization.
A clean room is a rigorously controlled environment that
has a low level of environmental pollutants such as dust,
airborne microbes, aerosol particles and chemical
vapours. The air entering a clean room is filtered and then
continuously circulated through high efficiency particulate
air (HEPA) and/or ultra-low particulate air (ULPA) filters to
remove internally generated contaminants. Staff wearing
protective clothing must enter and exit through airlocks,
while equipment and furniture inside the clean room is
specially designed to produce minimal particles.
Clean room Standard:
As per ISO 14644:
Room in which the concentration of airborne particle is controlled, and which
is constructed & used in a manner to minimize the introduction, generation,
and retention of particles inside the room and in which other relevant
parameters (e.g., temperature, humidity, and Pressure) are controlled as
necessary.
As per WHO-GMP:
An area with defined environmental control of particulate and microbial
contamination, constructed and used in such a way as to reduce the
introduction, generation, and retention of contaminants within the area.
As per USP Chapter 1116:
A room in which the concentration of airborne particles is controlled to meet a
specified airborne particulate Cleanliness Class. In addition, the concentration
of microorganisms in the environment is monitored; each Cleanliness Class
defined is also assigned a microbial level for air, surface and personnel gear
Why Cleanroom?
• Clean, safe and contaminant-free environment is imperative for
manufacturing efficacious, safe and good quality drug products or
packaging material or allied accessories
• Also critical to protect employees from contact with hazardous materials
or pathogens and prevent health problems from prolonged exposure to
chemicals or allergens
• Clean rooms are part of GMP requirement and GMP is statutory in
nature.
There are three major components of cleanrooms
-Design, Certifications and Documentation
-HVAC
-Partition
Design, Certifications and Documentation
We design complete facility as per the requirement of Local FDA(schedule
M),WHO,PICS,EUGMP & USFDA.
We also provide complete documentation (IQ, OQ & PQ) as well as
certification as per ISO 14644-1 & 2.
HVAC-Air Handling Concepts & Devices
Centralized Air-Conditioning System
Design of Cascade Cleanrooms
Optimizing a Cleanroom
Avoiding Contamination / Cleanroom Discipline
• Material Exchange / Air-Showers
• Enclosures for Machinery
• Reducing Power Consumption
- Machines / Process
- Lighting (T8 / T5 / other lamps)
• Work-Flow
- Storage next to end of production line
- Warehouse / Stock centralized
Cleanroom Design: Mono-Block Systems/Cleanroom Design: Modular Systems
Cleanroom Project Photos:
Partition, Doors &Windows
AHU & DUCTING
AHU AND DUCTING
