Views:0 Author:Site Editor Publish Time: 2020-10-20 Origin:Site
High efficiency filterThe necessity of leak detection!
1. In view of the characteristics and requirements of sterile preparation products, internationally proposed 100-level protection, and many domestic manufacturers adopt the particle counter scanning method to determine the design and installation of air purification systems in clean areas. Whether it meets the requirements, such verification is actually logically insufficient.
(1) In the freeze-dried powder injection workshop newly built by XXX Pharmaceutical Factory, after the purification test passed, the simulated production found that the insoluble particles exceeded the standard. After the leak detection of the high-efficiency filter by the PAO method, it was found that there were 30 high-efficiency filters in the 100-level area, and 20 failed, so replace one.
(2) So far, no manufacturer in the 10,000-level area has passed the PAO method for leak detection.
(3) The high efficiency filter in the tunnel oven rarely passes once.
2. In actual production, it often encounters more complicated and worse conditions than during inspection:
(1) It is static during inspection and dynamic during production. The particles produced between the two are not of the same order of magnitude, and the requirements for the filter capacity are also different.
(2) When testingHigh efficiency filterFor new installations, the breakage and leakage are basically within a relatively ideal range; after a certain stage of production, a certain degree of breakage, leakage and blockage may occur locally due to various reasons.
(3) Especially for the first inspection, the background environment is generally relatively ideal, and the air purification unit is turned on again 1 to 2 hours in advance; during production, it may encounter different severe weather, and it may be turned on at most 30 minutes in advance.
It is not difficult to see that the data obtained during verification and monitoring is more idealistic and more in line with the requirements than usual actual production.
Ten thousand bacteria protection.
The purpose of both is to ensure the sterility of the product and the controllability of insoluble particles, but the premise is that reliable hardware guarantees that the air purification system that meets the requirements is one of them. Therefore, the verification of the sterile preparation air purification system should be more complete and more reasonable than other dosage forms, and it should not only remain on the particle count and microbial count test qualified.