1) As a clean room design consultant, we help medical device manufacturers design clean rooms to strict ISO standards to minimize airborne particles and control environmental factors. 2) Clean rooms are facilities designed and operated to control pollution such as dust, microbes, and chemicals according to ISO 14644 clean room standards. 3) We design clean rooms to maintain low air particle levels as specified by ISO 13485 and ISO 14644 clean room design standards to ensure medical device quality and safety.

1. Clean Room Design
Consultants
ISO 14644
https://www.operonstrategist.com/clean-room-design-
consultant/

2. As a Clean Room Design consultants, we
provide expertise clean room design solution to
medical device manufacturers. Clean Room
helps in establishing & maintaining an
environment with a low level of environmental
pollutants such as dust, airborne microbes,
aerosol particles & chemical vapors.

3. What is Clean Room?
“A room in which the concentration of airborne particles is
controlled, and which is constructed and 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.” - ISO 14644-1
Clean Room is the facility ordinarily utilized as a part of
specialized industrial production or scientific research. For that,
clean room design is under the expertise is more important.

4. Clean Room Design:
Presence of unwanted air particles may
adversely affect the performance and safety of
a product and hence Medical Device
manufacturers are advised to manufacture
under classified areas.
Clean rooms of different sizes and complexity
are designed to maintain low levels of air
particles as per the ISO 13485, ISO 14644
Clean Room Design Standards.

5.  As a medical device Clean Room Design Consultant, we
Operon Strategist help in designing the medical device clean
room as per the desired levels of air quality.
 In addition, of controlling the air particle count, environmental
factors such as humidity, temperature, and pressure are also
considered while designing a clean room.

6. Clean Room Regulations – ISO 14644
To manufacture the clean room ISO class
system provides an industry-wide standard
that is ISO 14644 it’s the clean room
standard for cleanliness and particles
counts.
ISO 14644-1:2015 specifies the
classification of air cleanliness in terms of
concentration of airborne particles in clean
rooms and clean zones; and separative
devices as defined in ISO 14644-7.

7. What is this ISO 14644-1:2015 standard about?
This standard is all about improving quality
control in an environment by the limited
presence of sub-micron particles within the clean
room. It gives guidelines related to air
cleanliness, looking specifically at particle
concentration.

8. The ISO 14644-1:2015 standard is applicable
for?
 Clean room facility users, testers, consultants
 Vendors of clean room technology components such as air
filters, safety cabinets
 Healthcare operators/hospitals/clinics
 Healthcare design and build/research and development
 Healthcare manufacturing, including pharmaceutical and
medical devices
 Life sciences research and microelectronics and biomedical
technology

9.  Micro-mechanical industries
 Nanotechnology industries
 Optics
 Aerospace

10. Why is this ISO 14644-1:2015 standard
necessary?
 It focuses on the definition of air cleanliness by particle
number concentration and gives the updated classification
procedures specified to achieve this.
 This latest revision reflects recent advances in airborne
particle counting science and the improved statistical rigour
of cleanliness classifications for clean rooms and clean
devices.

11. Changes in the ISO 14644-1:2015 from the
previous?
 The 2015 revision takes into account improved industry
knowledge and a reconsideration of the levels of statistical
confidence that can be practically achieved during clean
room and clear air device classification. Changes include:
 Amendments to the method of evaluation of data collected
from airborne particle counting

12.  The basic ISO cleanliness classes 1 to 9 do not fundamentally
change, but the classification process requires the adoption of
a revised protocol for every clean room or clean air device
 The revised standards also include updated references to
normative and supporting standards

13. Thank You.
For More Information Contact Us
www.operonstrategist.com
info@operonstrategist.com
+91-9325283428