20*50ft Class 10, 000modular cleanrooms with Free Design

FS209E Clean room contains six classes, while the ISO 14644-1 classification system adds two cleaner standards and one dirtier standard (see chart below). The "cleanest" cleanroom in FS209E is referred to as Class 1; the "dirtiest" cleanroom is a class 100,000. ISO cleanroom classifications are rated according to how much particulate of specific sizes exist per cubic meter (see second chart). The "cleanest" cleanroom is a class 1 and the "dirtiest" a class 9. ISO class 3 is approximately equal to FS209E class 1, while ISO class 8 approximately equals FS209E class 100,000.

In November 2001, Federal Standard 209E was superseded by the new ISO 14644-1 international standards. References to FS209E are still used; the comparison chart below illustrates the relationship between the two standards.

Anlaitech cleanroom walls are made of durable, easy-to-clean, ISO-grade materials, as specified in FDA guidance documents. Combined with your cGMP processes, they will help you comply with operational requirements.

ISO 14644-1 standard Clean rooms

ISO14644-1 is the most widespread modern cleanroom standard that not only defines the design of clean rooms, but also provides guidelines for implementation and use. Many manufacturers base their requirement system on ISO-14644:

Technical Paremeters:

About Positive Pressure Clean room

Cleanrooms are designed to maintain positive pressure, preventing "unclean" (contaminated) air from flowing inside and less-clean air from flowing into clean areas. The idea is to ensure that filtered air always flows from cleanest to less-clean spaces. In a multi-chambered cleanroom, for instance, the cleanest room is kept at the highest pressure. Pressure levels are set so that the cleanest air flows into spaces with less-clean air. Thus, multiple pressure levels may need to be maintained.

A differential air pressure of 0.03 to 0.05 inches water gauge is recommended between spaces. In order to minimize disruptions to these cascading pressures when doors are opened, air locks are often specified between rooms of differing ISO cleanliness levels. Automated fan controls simplify pressure balancing by allowing fan speed adjustments at a centralized console panel.