Overview
Last week we have introduced different stainless steel tubes, i.e. AP tubes, BA tubes & EP Tubes. As clean BA and EP tubes are all packed in clean rooms, we’d like to make a further introduction on ISO clean room classifications to provide a panoramic view of stainless steel tubes that CIVMATS boast of.
What is A Clean Room?
A clean room is a strictly controlled ultra-clean environment where airborne particles are limited and where other parameters like room temperature, humidity, pressure and personnel entry and exit are regulated per requirements of standard such as ISO 14644-1, Federal Standard 209E, and the EU GMP.
Among the above mentioned standards, ISO 14644-1 is the most widely accepted framework for clean room classifications worldwide, for which our title is named.
Clean Room Features
To constitute a clean room, there are several features that the environment must embody, as below,
- • Sophisticated filtration system to filter dust, microorganisms and bacteria etc.
- • Controlled unidirectional flow to minimize the risk of cross-contamination.
- • Regular checks for the above mentioned parameters to maintain optimal cleanliness levels.
- • Regulated personnel access with specific hygiene practices to prevent external pollutants.
- • Appropriate garments to prevent the introduction of contaminants.
- • Cleaning protocols on clean room surfaces like walls and equipment to avoid the accumulation of microbial contamination.
- • Right building materials such as smooth, non-porous, easy-to-clean surfaces to reduce potential particle retention and microbial growth.
- • Proper employee training on cleanroom protocols and hygiene practices.
Why Build A Clean Room?
A clean room is built to create an environment where production of certain products can be operated with the highest level of hygiene status and safety. Clean room cleanliness level can directly impact product quality and even safety for certain industries, to name just a few, as below listed,
- • Medical industry
- • Biotechnology
- • Transportation of high-purity gases or liquid
- • Lab supplies
- • Semiconductor manufacturing
- • Aerospace engineering
Violation of the required clean room standard can result in direct financial loss from product defects, unqualified product recalls or/and delayed lead time. There are also indirect losses such as penalties or revoke issued certificates from other parties.
ISO Clean Room Classifications
According to ISO 14644-1, there are 9 classes of cleanrooms, from ISO 1 (the highest standard of cleanliness) to ISO 9 (the lowest standard of cleanliness), classified per concentration of particles per cubic meter at specified particle sizes as below,
| Maximum Allowed Particles Per Cubic Meter of Air | ||||||
|---|---|---|---|---|---|---|
| Class | ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥1.0 µm | ≥5.0 µm |
| ISO 1 | 10 | 2 | … | … | … | … |
| ISO 2 | 100 | 24 | 10 | 4 | 8 | … |
| ISO 3 | 1,000 | 237 | 102 | 35 | 83 | … |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 832 | … |
| ISO 5 | 100,000 | 23,700 | 10,200 | 320 | 8,320 | 29 |
| ISO 6 | … | … | … | 35,200 | 83,200 | 293 |
| ISO 7 | … | … | … | 352,000 | 832,000 | 2,930 |
| ISO 8 | … | … | … | 3,520,000 | 8,320,000 | 29,300 |
| ISO 9 | … | … | … | 35,200,000 | 83,200,000 | 293,000 |
ISO 4 Class Clean Room for Stainless Steel EP Tubes
For stainless steel EP tubes, each tube must be purged with ultra-high purity (UHP) nitrogen, capped and double bagged in Class ISO 4 Cleanroom conditions. At CIVMATS, clean BA stainless steel tubes apply to the same condition upon requirement.
According to the table, ISO 4 cleanroom is designed to meet a maximum of 10,000 particles/m3 at sizes of 0.1 or above microns. Though not as stringent as class 1~3, a class ISO 4 clean room offers a quite low particle count, free from contaminants that could hurt product quality or performance. Meeting the ISO 4 requirement means a controlled environment where the integrity of stainless steel EP tubes can be maintained, and the pertained applications meet.
Clean Room Stainless Steel EP Tubes from CIVMATS China
At CIVMATS, we produce clean room stainless steel EP tubes and clean BA tubes with high quality approved by third party TUV inspection and win acclaim from our global clients. Welcome for your consultation and purchase.
