You are here: Home » News » The Construction of 100,000-Level Clean Room

The Construction of 100,000-Level Clean Room

Views: 0     Author: Site Editor     Publish Time: 2025-09-28      Origin: Site

Inquire

facebook sharing button
twitter sharing button
line sharing button
wechat sharing button
linkedin sharing button
pinterest sharing button
sharethis sharing button
The Construction of 100,000-Level Clean Room

100,000-Level Clean Room  Workshop Standard

The standard for a 100,000-level purification workshop can be understood from the perspective of industry standards as a standard related to cleanliness. Generally, there are five levels of cleanliness classification: 10-level, 100-level, 1,000-level, 10,000-level, 100,000-level, and 300,000-level.A 100,000-level cleanroom refers to a working environment where the number of particles per cubic meter is controlled to be less than 100,000.


净化车间

From the perspective of the number of breaths:

For the 100,000 (100,000-level) category, it is required to have 18-25 air changes per hour, and the total air purification time after complete ventilation should not exceed 40 minutes.

For the 10,000 (10,000-level) category, it is required to have 25-30 air changes per hour, and the total air purification time after complete ventilation should not exceed 30 minutes.

At the 1000 (1 thousand) level, it is required to have 40 to 60 breaths per hour, and the air purification time after complete ventilation should not exceed 20 minutes.

The standard for a 100,000-level purification workshop is:

1. Maximum allowable number of dust particles (per cubic meter);

2. The number of particles larger or equal to 0.5 micrometers shall not exceed 3,500,000, and the number of particles larger or equal to 5 micrometers shall not exceed 20,000;

3. Maximum allowable number of microorganisms;

4. The number of suspended bacteria shall not exceed 500 per cubic meter;

5. The number of settled bacteria shall not exceed 10 per petri dish.

Pressure difference: The pressure difference of purification workshops of the same cleanliness level should be consistent. For adjacent purification workshops of different cleanliness levels, the pressure difference should be ≥ 5 Pa, and the pressure difference between the purification workshop and the non-purification workshop should be ≥ 10 Pa.

净化车间2

Verification methods and procedures for a 100,000-level purification workshop:

1.The measuring instruments and equipment required for the test

(1)Temperature and humidity meter

(2)Thermal ball anemometer

(3)Differential pressure gauge

(4)Dust particle counter

(5)Portable stainless steel pressure steam sterilizer

(6)Constant temperature incubator

2.Verification of the architectural decoration in the purification workshop

  1. Power distribution and lighting facilities requirements

  2. Plant structure requirements

  3. Piping requirements for water supply and drainage

  4. Other ancillary facilities

3.Verification of the purification air conditioning system

(1)Installation requirements for air high-efficiency filters

(2)Confirmation of the operation of the air conditioning system

(3)Performance verification of the air conditioning system

净化车间3


With over 18 years history till now, we have became professional in the production and development of syringes and infusion set production molds, machines and other necessary equipment.
Leave a Message
Contact Us

QUICK LINK

PRODUCT CATEGORY

CONTACT US

   Address: No.3397, Zhencheng Road,  Jiangyin, China
  Tel: +86-591 8711 2019
   Mobile: +86-13850118259
   E-mail: info@smartell.com
Copyright  2022 SMARTELL TECHNOLOGY CO., LTD. All Rights Reserved.  Sitemap | Support By Leadong