1. The design of the clean area must meet the corresponding "static" standards to meet the "dynamic" cleanliness requirements. "Static" refers to the state in which the installation is complete and running, but no operator is present. And "dynamic" refers to the state in which the production facility operates according to the predetermined process mode and has a specified number of operators on site.

2. After all the production operations are completed, and the operators leave the production site and self-clean for 15-20 minutes (guidance value), the clean area should reach the "static" standard in the table. The dynamic test results of the direct exposure of drugs or open containers to environmental particles should reach A-level standards in the table.

3. The environment level of the isolation operator for aseptic operation should be at least level D.

4. In order to determine the level of A-level areas, the sampling volume of each sampling point shall not be less than 1m3. The level of air dust particles in Class A area is IlSO4.8, with the dust particles of z0.5yum as the limit standard. The level of air dust particles in Class B area (static) is ISO 5, including dust particles of the two particle sizes in the table. For zone C (static and dynamic), the levels of airborne dust particles are ISO7 and ISO 8, respectively. For the class D area (static) the level of air dust particles is ISO8. The test method can refer to ISO14644-1.

5. When confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the settlement of >5.0um dust particles in the long sampling tube of the remote sampling system. In unidirectional flow systems, an isokinetic sampling head should be used.

6. It can be tested during routine operation and medium simulation filling process, which proves that it has reached the dynamic level, but the medium simulation test requires dynamic testing under the 'worst case'.

Suzhou Pharma Machinery Co.,Ltd.

2023/02/15

Birkey