How to reduce the cross contamination caused by cyclic siloxane after heating the silica gel hose? The leachables and extractions brought by the pharmaceutical production equipment also pose a great threat to the pharmaceutical production process. The latest research results show that this risk can be significantly reduced by adding a silicone hose after heating process.
Drugs must meet the requirements of the highest purity. When pollutants are found on drugs, in order to find out the causes of pollution, pharmaceutical enterprises begin to search for the root of very complicated. However, when the process equipment used in the pharmaceutical production process has problems, how to deal with it? In fact, problems in process equipment will be more common. Dr. Sade mokuolu, compliance technical manager of Watson Marlow, also believes that people underestimate the seriousness of the problem. "It is worth noting that 15% of all drug recalls discovered by the FDA in the past six months are caused by contamination of pharmaceutical process equipment."
One of the core problems of drug pollution is the direct contact between disposable plastic appliances and drugs, which may produce compounds that have negative effects on the final efficacy, safety and drug quality. In high cost drug testing or clinical trials, the consequences of this direct contact even extend to the drug development process, and has a great impact on the reputation of the drug brand. "Therefore, pharmaceutical manufacturers should also focus on the process equipment and accessories used in the production process. In particular, more attention should be paid to platinum cured silicone tubes, because harmful substances that may eventually leach into drugs are used in the production process of the silicone tubes. " Dr. mokuolu said.
It is a very valuable thing to study the silicone tube used in the pharmaceutical production process. In order to achieve this goal, Watson Marlow company has produced a silica gel tube named pumpsil in its factory in Falmouth, UK, which uses the most advanced 7-level clean room and fully complies with ISO 14644-1 standard. In addition, in the production process of silicone tube, a process step of post-treatment after heating is added to improve the stability of silicone tube. This not only improves the connection between molecules, improves the mechanical stability of the silicone tube, but also reduces the wear, thus prolonging the service life of the silicone tube. The most important thing is to reduce the formation of semi volatile compounds.
If the platinum cured silicone tube is not heated for post-treatment, there will be a risk of cyclosiloxane entering the transported liquid when the silicone tube contacts the transported liquid. Dr. mokuolu stressed that drug manufacturers should be aware of this safety risk. The results of the research and experiment show that the effect of the heating and post-treatment of silica gel hose has been verified, and the benefits brought by it have left a deep impression on people. Pharmaceutical enterprises should take the heating and post-treatment equipment as their standard equipment. In this study, the silicone hose tested not only includes the sample of pumpsil brand silicone hose, but also the sample of untreated silicone hose. These samples were placed in 50% ethanol solution (50% ethanol, 50% water), and the comparison test was carried out for the two types of silicone tubes under two conditions: one was in contact with the above solution at 25 ℃ for 30? Min, the other was in contact with the above solution at 40 ℃ for 7 days. In the framework of this study, the potential toxicity of cyclosiloxane extract was also the focus of this research project.
Not all manufacturers can finish the post heating treatment
The results show that the leaching amount of cyclic siloxane in the heated silica gel hose is at least 25% less than that in the unheated silica gel hose after 7 days of contact with the ethanol solution, and the value of cyclic siloxane in the heated silica gel hose is lower than that in the unheated silica gel hose after 30? Min contact with the ethanol solution 50.
After heating (left), not after heating (right)
Dr. mokuolu's final advice to Biopharmaceutical Enterprises is: "our test results show that the silicone hose after heating has better performance, which significantly reduces the leaching amount of cyclosiloxane. Pharmaceutical companies should keep this conclusion firmly in mind. Post heating treatment helps to maintain the efficacy of drugs, improve their safety and quality, and thus make a positive contribution to business success. "
The writer is business manager of Watson Marlow company.