Technical guidance for the container closure system of peritoneal dialysis solution
2020/04/26 12:44:59
Peritoneal dialysis (PD) is an effective blood purification procedure features in simple operation, low medical costs and convenience for popularization and application and plays an irreplaceable role in improving the remedy rate of uremia patients in China. Due to the features of the PD treatment, it has a relative high degree of dependence on the container closure system. Therefore, the Container Closure System has a great effect on the drug quality of peritoneal dialysis solution and therapeutic effect on the patients.
According to the China’s regulations, some components of the Container Closure System of Peritoneal Dialysis Solution, transfer tubing, drainage bag, connector and protective cap, are classified as managed as Class II medical devices; the soft bag (solution bag) and components (connective tubing, injection port, frangible) in contact with the solution are classified as pharmaceutical packaging and subject to the management as required by Associated Review & Approval . The guidelines are the technical guide for drug packaging product. In the preparation of the guidelines, the current supervision situation has been taken into account, for example, in the technical requirements, there is no detailed requirements for the components subject which are managed as medical devices, just indicate that the components subject need to meet the relevant regulatory requirements. But because components subject is an impartible part of the Container Closure System of Peritoneal Dialysis Solution, so the performance requirements of the intended use to be met after product combination is also taken into account in the preparation of the technical requirements of the overall Container Closure System, such as that relevant requirements regarding the fitting performance of connectors, infusion time/drainage time shall also be met.
The purpose of this Guidance is to provide guidance to the enterprises for continuous improvement from design R&D, manufacturing, quality control, technical requirements, compatibility study to storage and transportation. The manufacturing units and user units shall provide sufficient guidance for product use so as to ensure the medication safety and improve the patient operation convenience and the life quality.