At present, aseptic preparation filling mainly uses two forms of filling pumps, one is a ceramic plunger pump, and the other is a peristaltic pump. Ceramic plunger pumps have the advantage of high precision, but they also have disadvantages such as high shear force and small filling range. For some high-end aseptic preparation filling, peristaltic pumps are currently used more.In the process of filling aseptic preparations, ensuring sterility and filling accuracy are the basic requirements, so the peristaltic pump needs to meet the following requirements:
The aseptic preparation filling process is required to be carried out in a Class A environment, so the peristaltic pump is required to be made of all stainless steel and can be embedded in the isolator to save installation space.
Aseptic preparations, especially high value-added preparations, such as vaccines, monoclonal antibodies, etc., require a yield of more than 98% for drugs, so filling accuracy is very important. The high-precision dispensing peristaltic pump adopts the multi-roller cross design, which can effectively reduce the pulse, deliver the liquid more stably, improve the filling accuracy, and thus improve the yield of the drug. The peristaltic pump filling system can also be designed to collect tail fluid to minimize the waste of liquid medicine.
In the field of sterile formulation manufacturing, sterility assurance is critical, so filling lines must be sterile. At present, the biopharmaceutical field basically uses disposable pipeline components, which have been sterilized by irradiation before use. During the filling process, the liquid medicine is transported through aseptic pipelines, eliminating the risk of contamination.
