Iso5 Cleanroom & Iso 8 Cleanroom Manufacturer

What is ISO clean room?

An ISO clean room is a controlled environment that meets the cleanliness standards set by the International Organization for Standardization (ISO) in their series of standards ISO 14644. These standards define the air cleanliness by specifying the maximum concentration of particles in the air per unit volume, based on particle size. The classification system ranges from ISO 1 to ISO 9, with ISO 1 being the cleanest and ISO 9 having the most particles.

In an ISO clean room: Airborne particulate levels are tightly controlled and regularly monitored.The number and size of particles per cubic meter of air are specified; smaller numbers indicate stricter control over particulates. Particles include dust, hair, skin flakes, fibers, and other contaminants that can affect manufacturing processes, particularly those in industries such as semiconductor manufacturing, pharmaceuticals, biotechnology, medical device production, and aerospace where high levels of precision and contamination control are critical.

For instance, an ISO Class 5 cleanroom allows no more than 10,000 particles equal to or larger than 0.1 microns per cubic meter of air, while an ISO Class 1 cleanroom allows just 12 particles of the same size per cubic meter.

The design and operation of ISO clean rooms involve sophisticated air filtration systems, careful material selection, gowning procedures for personnel, and strict operational protocols to maintain the required level of cleanliness.

Class	Maximum particles/m³						FED STD 209E equivalent
Class	>=0.1μm	>=0.2μm	>=0.3μm	>=0.5μm	>=1μm	>=5μm	FED STD 209E equivalent
ISO 1	10	2
ISO 2	100	24	10	4
ISO 3	1,000	237	102	35	8		Class 1
ISO 4	10,000	2,370	1,020	352	83		Class 10
ISO 5	100,000	23,700	10,200	3,520	832	29	Class 100
ISO 6	1,000,000	237,000	102,000	35,200	8,320	293	Class 1,000
ISO 7				352,000	83,200	2,930	Class 10,000
ISO 8				3,520,000	832,000	29,300	Class 100,000
ISO 9				35,200,000	8,320,000	293,000	Room air

BRIEF INTRODUCTION:

Clean room (also known as cleanroom): A room with a controlled concentration of airborne particles.

SUZHOU PHARMA MACHINERY has kinds of clean room: iso5 cleanroom, iso 6 cleanroom, iso 8 cleanroom,iso7 cleanroom.Its construction and usage should reduce indoor inducement and generation of retained particles.

Other relevant indoor parameters such as temperature, humidity, pressure, etc. are controlled as required. It should be pointed out that the clean room can not completely eliminate the pollution, but control it at an acceptable level.

As a result, GMP began to define and control the sources of particulates,to try to control possible "microbial contamination.".

The presence of personnel in clean rooms is usually the highest source of risk of particulate and microbial contamination in the air,so proper gowning and limiting the number of staff into a room must be carefully controlled to be within the clean room design.

It's widely used in water treatment system, liquid filling machine, tablet production line, pharmaceutical machine, oil extraction line, formulation processing plants, filling and packing lines, PET packaging,foil sealing, medical device & pharmaceutical packaging, aseptic manufacturing and repackaging, non-PVC soft bag IV solution production line, etc.

Find details about SuZhou Pharma iso5 cleanroom, iso 6 cleanroom, iso 8 cleanroom,iso7 cleanroom followings.