Class 10,000 Cleanroom Requirements | Design & Manufacturing

What Is a Class 10,000 Cleanroom?

Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to FED-STD-209E, and denote the number of particles of size 0.5 µm or larger permitted per cubic foot of air. Class 10,000 would have <10,000 particles/cubic foot. Minimum of 45 to 60 air changes per hour.

Various Class 10,000 Applications:

Pharmacy compounding rooms
Semiconductor non photolithography (bonding, metal deposition, testing)
Pharmaceutical manufacturing
Aerospace manufacturing

Typical Class 10,000 Cleanrooms Utilize:

Gowning room /air locks
Product pass thru’s
Heat welded vinyl or epoxy floors
Air conditioning for temperature control
HEPA fan filter units
Sealed cleanroom lighting
Magnahelic gauge for room air pressure monitoring
Workers typically garb up in non particulating cleanroom bunny suits, booties and hoods.
Some applications use air showers to enter.
Sticky mats at entrance and exit
Stainless steel bench
Gown racks
Stainless steel - hand free sinks

Design:

Negative pressure plenum
Ceiling mounted HEPA fan filter units and low wall air returns for laminar air flow
Cleanable hard walls

Softwall Class 10,000 option:

Clear vinyl walls
Strip curtain for entrance
Steel frame
Ceiling mounted HEPA FFU’s
Ceiling mounted lighting
Sometimes mounted on casters

Softwall Class 10,000 Limitations:

No temperature control
No measurable positive pressure
Cannot clean walls

Class 10,000 Softwall Typical Applications:

Inside Class 100k room
Inside warehouse
Weighing product during packaging
Inspection stations
Temporary cleanroom

FAQs About Class 10,000 Cleanroom

Q: What is the Difference Between a Class 10,000 and a Class 1,000 Cleanroom?

A: A class 10000 cleanroom is allowed a maximum of 70 particles/ft3 greater than 5 microns and less than 10,000 particles/ft3 greater than 0.3 um. Class 10000 must have at least 60 air changes per hour. A class 1000 room is allowed a maximum of 7 particles/ft3 greater than 5 micron and less than 1000 particles/ft3 greater than 0.3 um. Class 1000 must have at least 180 air changes per hour. A Class 10000 cleanroom classification is closest to ISO-7. A class 1000 cleanroom classification is closest to ISO-6.

Q: What is a 100,000 Cleanroom?

A: A class 100000 cleanroom is allowed a maximum of 700 particles/ft3 great than 5 microns and less than 100000 particles/ft3 great than 0.3 microns. Class 100000 must have at least 20 air changes per hour. A class 100000 cleanroom classification is closest to ISO-8

Q: What Does the Term Class 10 Cleanroom Mean?

A: A class 10 cleanroom is allowed no particles greater than 5 microns, less than 10 particles/ft3 greater than 0.5 um and less than 30 particles/ft3 great than 0.3 microns. Class 10 must have more than 300 air changes per hour. A class 10 cleanroom classification is closest to ISO-4.

Q: What are Cleanroom Requirements?

A: Cleanroom requirements typically refer to cleanroom classification, length, width, height, wall type, air flow of either recirculating or one pass, temperature, humidity, and room pressure. Other requirement can be related to exhaust, chemical resistance, biohazard, electrical discharge or light frequency.

Q: What is a Class 10 Cleanroom?

A: A class 10 clean room is allowed no particles greater than 5 microns, less than 10 particles/ft3 greater than 0.5 um and less than 30 particles/ft3 great than 0.3 microns. Class 10 must have more than 300 air changes per hour. A class 10 clean room classification is closest to ISO-4.

Q: What is the Highest-Class Cleanroom?

A: ISO-9 is considered the high ISO cleanroom classification. The particle counts correspond to room and is roughly 10x as dirty as ISO-8. Class 100k is the highest FED Std 209E cleanroom classification. Class 100k is closest to ISO-8.

Q: What are the Classes of Cleanrooms?

A: The Fed Std. 209E cleanroom classifications are class 100000 (class 100k) , class 10000 (class 10k), class 1000 and class 100. The ISO cleanroom classifications are ISO-5, ISO-6, ISO-7 and ISO-8.

Q: What is a Class 10k Cleanroom?

A: A class 10k cleanroom is allowed a maximum of 70 particles/ft3 greater than 5 microns and less than 10,000 particles/ft3 greater than 0.3 um. Class 10k cleanroom must have at least 60 air changes per hour.

Q: What ISO Class is a Cleanroom?

A: The ISO class of cleanroom is defined by how many particles per cubic meter and how many air changes per hour with hepa filtered air.

Q: How are Cleanrooms Classified?

A: Cleanrooms are classified by particle count and HEPA filtered air changes per hour. Particle counts range from 0 to 700 particles/ft3 greater than 5 um, and air changes from 20 to 300 air changes per hour for FED Std 209E. For example a class 10,000 cleanroom is allowed 70 particles/ft3 greater than 5 microns, 10,000 particles/ft3 greater than 0.3 microns and minimum 60 air changes per hour. ISO cleanroom classifications are also by particle count and HEPA filtered air changes per hour. However the particle counts are by meters3.

Class 10,000 Cleanroom