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In order to meet the high standard requirements for water use in pharmaceutical production lines, the process performance of pharmaceutical purified water equipment is certainly efficient
.
However, due to the influence of environment, equipment and process, water is easy to breed microorganisms and help them grow, so microbial indicators are its important quality standards.
In the design, installation, verification, operation and maintenance of pharmaceutical purified water equipment systems, various measures to inhibit its growth
.
The editor believes that reasonable and scientific design can better prevent microbial pollution.
Starting from the design principles of water systems, controlling pollution from the source is the key to solving the problem
.
First, the pretreatment stage is adopted to reduce biodegradable organic matter and sterilize
.
Conventional sterilization methods include chlorination or hypochlorite, ozone, ultraviolet sterilizers, and the like
.
Non-oxidizing bactericides such as DBNPA or isothiazolinone can also be used for impact sterilization of purified water equipment
.
When microbial contamination occurs in the equipment, sterilization and chemical cleaning should be carried out in time to prevent the proliferation of microorganisms
.
In order to prevent microorganisms from developing drug resistance, it is necessary to change the types of fungicides and sterilization methods from time to time
.
Avoid Dead Spaces Good engineering practice is to minimize or eliminate dead spaces where possible
.
A common practice is to limit the dead space to less than 6 branch pipe diameters or smaller, which is derived from the "6D" provisions proposed in the 1976 CFR212 specification
.
More recently, industry experts have recommended 3D or smaller for guidance, while the WHO recommended dead space length is 1
.
5D or smaller
.
However, this new guidance has caused confusion because proponents of this standard usually discuss the length of the dead end from the outer wall of the pipe, whereas the original 6D code referred to the distance from the center of the pipe to the end of the dead end
.
Obviously, if a 1/2" branch is placed on a 3" main pipe, there is already 3D from the center of the main pipe to the outer wall of the pipe
.
Therefore, even zero dead-leg valves may fall short of 3D requirements
.
During the design, special attention should be paid to the problem of microbial growth, and the growth of microorganisms should be avoided as much as possible through the system process design, so as to ensure that the water produced reaches the standard and meet the high standard requirements of the pharmaceutical production line for production water
.