Classification and Requirements for

designing clean room for Medical

device Manufacturing
 Medical Device Classification FDA:
• Class 1 devices are perceived to be the lowest risk devices. 1. Examples include
medical tape and bandages.

• Class 2 devices are perceived to be of greater risk to the patient or user. General
controls are not sufficient for safety or efficacy. Most coronary catheters fall within
this classification.

• Class 3 devices are perceived to represent the highest risk to patient or user. These
devices support or sustain human life, may prevent or impair human health, or
present potential risk of illness or injury. Examples include heart valves and
pacemakers. 
 Cleanroom:
• A cleanroom is a room or space
where particulates (visible and non-
visible/ Microorganism) are
controlled and monitored.

• A cleanroom or clean room is an

engineered space, which maintains
a very low concentration of airborne
particulates. It is well isolated, well-
controlled from contamination, and
actively cleansed. Standards and
guidelines such as ISO 14644-3
require monitoring of temperature
and air humidity with certain
accuracies.
FDA 21 CFR 211.42 addresses design and construction features. According to the
regulation:

•The facility must be of suitable size, construction, and location so that cleaning,
maintenance, and operations can be properly performed.

•The facility must have adequate space and flow design to prevent mix-ups and cross-
contamination.

•Surfaces must be easy to clean.

•Temperature and humidity must be controlled as appropriate.

•Air must be positive pressure and HEPA filtered.

•Environmental conditions must be monitored.

•Room and equipment must be cleaned and disinfected properly.

•Equipment must remain in aseptic conditions.

https://blog.gotopac.com/2018/12/20/cleanroom-design-medical-device-class/
 Cleanroom Classifications for Common Medical
Device Applications

Application Classification

Device Reprocessing ISO Class 7

Implantable Devices ISO Class 5

Medical Device Packaging ISO Class 7-8

https://www.gotopac.com/medical-device-cleanrooms#rfq
 Broadly, medical device manufacturing is conducted in an ISO 5 – 8 cleanroom
(Class 100 – 100,000).

https://blog.gotopac.com/2018/12/20/cleanroom-design-medical-device-class/
 • ISO 7 – 8 cleanrooms are common for Class I and Class II medical devices. 

• Ventilator fall in class 2 according to search so ISO 7-8 Cleanroom environments are
suggested for ventilator production.

• Medical device packaging is conducted in an ISO Class 7- 8 cleanroom.

• An ISO 8 environment may include a dedicated gowning room.

https://blog.gotopac.com/2018/12/20/cleanroom-design-medical-device-class/
The requirements for an ISO Class7 clean medical room would generally align
with the ISO 14644 standard(attached).

Requirement for air borne particles are mentioned in above slides.

Some other key requirements are mentioned below:

• Filtration: HEPA filters or ULPA filters are commonly used in clean medical rooms
to effectively remove particles from the air and maintain the desired cleanliness
level.
• Temperature and Humidity:. The temperature should typically be controlled within
the range of 20 to 24 degrees Celsius (68 to 75 degrees Fahrenheit). The
recommended humidity level typically falls within the range of 30% to 60% relative
humidity.
• Pressure: The overpressure of the clean room must be between 5 and 20 Pa, and this
should be monitored using suitable differential pressure measuring systems.

ISO 14644-1:2015 - Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle conce
ntration
• Cleanliness Monitoring: Regular monitoring and testing of the clean medical room
environment should be conducted using appropriate particle counting equipment
(Particle Counter, Environmental Monitoring System etc. ) and techniques to ensure
compliance with the ISO Class 6 standards.

• Cleanroom Garments and Procedures: Strict gowning procedures, including the

use of cleanroom suits, gloves, masks, shoe covers, and hair covers, should be
followed to minimize the introduction of contaminants by personnel entering the
clean medical room.

• Additional Considerations: In medical settings, additional requirements might

include separate areas for sterile storage, proper handling and disposal of hazardous
materials, ventilation for control of chemical fumes or odors, and compliance with
specific medical regulations, such as Good Manufacturing Practices (GMP) or Good
Laboratory Practices (GLP).

ISO 14644-1:2015 - Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle conc
entration
Cleanroom Air handling unit:
In the schematic drawing: Air enters through a unit for air treatment, where it undergoes
initial filtration as well as temperature and humidity treatment.

This air passes through air conditioning ducts and enters into a cleanroom through HEPA
filters. Air returns from rooms through a grill inside the room to the plenum and air
conditioning ducts lead the “dirty” air out or return to the rooms through an air treatment
unit.

https://rs-ness.com/cleanroom-design/
 Airflow pattern
There are two types of airflow patterns for cleanroom design:

Type 1: Unidirectional
(Laminar flow)

• Airflow pattern in which

essentially the entire body of air
within a confined area moves
with uniform velocity in a single
direction with generally parallel
air streams (Grade A/ ISO 5).

https://rs-ness.com/cleanroom-design/
 Airflow pattern

Type 2: Non-
unidirectional flow
(Turbulent flow)

• Airflow is non-
unidirectional by having a
varying velocity, multiple
pass circulation, or
nonparallel flow direction
(Grade B, C, D/ ISO 7,8

https://rs-ness.com/cleanroom-design/
Airflow pattern

Positive Pressure:
• Positive pressure means the air pressure inside your
cleanroom is greater than outside.
 Airflow pattern
Positive Pressure:
Airflow pattern
Negative Pressure:

• In a negative air pressure cleanroom, the air pressure in the room is lower than
outside pressure.
Negative Pressure:
 Plenum& Air Exhaust inside the
cleanroom

https://blog.gotopac.com/2019/11/19/medical-device-cleanroom-construction-part-5-hvac-balancing-
calibration/#Cleanroom_Plenum_Design
 There are various types of particle counters that can be
used in ISO Class 7 clean rooms.

• Handheld Particle Counters: These portable devices are

convenient for spot checks and measurements in different
areas of the clean room. They typically provide real-time
monitoring and are easy to use.

• Portable Particle Counters: Similar to handheld

counters, these devices are lightweight and portable,
allowing for flexibility in monitoring particle counts at
different locations within the clean room.

• Remote Particle Counters: These particle counters are

installed at fixed locations within the clean room and
provide continuous monitoring. They are often integrated
into the clean room's monitoring system.

https://kanomax.biz/asia/products/
Differential Pressure Gauges/Controllers
• MAGNEHELIC ,PHOTOHELIC & DIGIHELIC
differential pressure gauges maintain positive pressure
necessary to block inrushing contaminants
• Incorporates an exclusive MAGNEHELIC Principle that
eliminates wear, backlash, and hysteresis
• Measure and control both positive and negative low air
or gas pressures
• Provide an ideal way of monitoring and controlling the
positive pressure differential required for cleanrooms
• Applicable when gauging air filters, monitoring air
conditioning systems, and measuring static air pressure
and air vehicles
Brand : Terra Universal
Origin: USA
Price: $90-1000 USD
PPEs: according to ISO13485, for class II devices

1. Gloves:
• Nitrile gloves are extremely strong and durable, while being resistant to punctures
and tears.
• Nitrile gloves are highly resistant to chemicals and solvents.
• Medical-grade gloves are usually made out of nitrile because this material is
resistant to fats and oils in the body
PPEs: according to ISO13485, for class II devices

2. Lab coat:
• Material: Poly propylene
• Characteristics: soft, light, non-toxic, durable, eco-friendly, economical.
Nonwoven is breathable, which makes it perfect for the workplace where
constant dirt and grime is encountered, also protect against the effects of
chemical dusts, paint sprays, asbestos, and other airborne dusts.
• With buttons, easy to put on and take off
PPEs: according to ISO13485, for class II devices

3. Shoe cover:
• Material: polyethylene
• Characteristics: Elasticated edges for better protection.
Easy to put on and take off
PPEs: according to ISO13485, for class II devices

4. Goggles:
• Super-soft thermoplastic frame
• Small upper vents for ventilation
• Toughened polycarbonate, anti scratch, anti-fog, optically correct lens
• Non-linting latex-free head band
• Can be worn over eye-glasses
THANK YOU