In recent years, Auto Cleaner equipment in the pharmaceutical industry more and more widely - mainly due to Auto Cleaner equipment can effectively save labor and cleaning time, another key factor is the Auto Cleaner equipment can be very good to repeat the work to ensure that The reproducibility of the cleaning effect. However, the author in a few years on a number of pharmaceutical companies in the consultation work found that part of the pharmaceutical companies on the application of Auto Cleaner equipment or operation of the emergence of the deviation, and even some of the Auto Cleaner equipment manufacturing enterprises in the design phase of the equipment , This article will be a simple analysis of these easy problems in order to expect the relevant pharmaceutical companies and equipment manufacturing enterprises to help.
Due to the diversity of the production of pharmaceutical companies and the complexity of the product itself, the procurement of Auto Cleaner equipment also requires pharmaceutical companies according to their product characteristics of the cleaning method development, and at this stage a lot of pharmaceutical companies have ignored the process, Auto Cleaner equipment installed directly after the use of equipment manufacturers to provide a common cleaning method, which
Many pharmaceutical companies in the preparation of Auto Cleaner equipment standard operating procedures will be the conductivity standard as the washing end, but ignored the flushing time, rinse flow rate, rinse pressure control. It is foreseeable that in this case different operators, if only the conductivity as the end of the rinse, then certainly can not guarantee the time of each rinse, water and other factors to maintain consistency, and these factors are successful clean validation of the first condition. Appropriate selection of cleaning parameters can greatly simplify the cleaning verification process.
"Quality comes from the design", if the design of the error, then only rely on the latter part of the operation is clearly unable to avoid the problem. For example, a traditional Chinese medicine extraction enterprises appeared on the following mistakes: In the extraction of a tank cleaning device design process, the company engineers in the purified water pipe opened a branch directly to the tank body, in the drainage pipe with online Of the conductivity detector to detect the conductivity of flushing water, and developed a corresponding standard, coupled with the valve control to form a simple online cleaning. However, the device can not control the critical process parameters such as flow rate, pressure and flushing time of purified water. Assuming that the pressure of a purified water is not enough, it is clear that this cleaning will take longer and affect the production schedule. It is assumed that the conductivity of purified water in a certain cleaning process suddenly exceeds the standard, then in this case, the cleaning will have no end.
The cleaning method has not been fully developed
For a given cleaning agent and dirt, the most important parameters that determine the cleaning performance are the cleaning time, the effect on the surface and the rinse strength, the concentration of the cleaning agent, and the temperature of the cleaning solution. Cleaning time, effect, concentration and temperature, are closely related. It is possible to use one parameter to compensate for another parameter to achieve the same cleaning performance. This requires pharmaceutical companies to study the cleaning process according to the characteristics of their own products, rather than directly using the supplier to provide a common method.
A good understanding of the chemical properties of the dirt being cleaned and the mechanism of the cleaning agent helps to screen the cleaning process parameters. The cleaning agent can be evaluated by laboratory cleaning studies and certain parameters such as cleaning time, temperature, and concentration are determined. The dirt that needs to be cleaned is applied to a flat surface plate and then air dried or dried to simulate the worst case that may occur during the cleaning process. This step requires simulation of the production process as much as possible. The test pieces are then cleaned with various cleaning agents and in accordance with the desired cleaning step, for example by stirring in a laboratory glassware or by washing at the flow rate of the simulated process.
Laboratory evaluations can provide a proven theoretical basis for the selection of cleaning agents and parameters. However, the final confirmation of the cleaning effect should be from the on-site process cleaning test. For some parameters or factors, there may be some limitations in the cleaning process to reach the maximum. This may include restrictions on the time of completion of the cleaning process, the temperature limits, or the ration or limitation of the most difficult to clean position when handling the existing cleaning process. It is important to take into account the most difficult cleaning of the process equipment.