Validation of solution preparation systems for parenteral products

Abstract

The development of solutions preparations systems technology, supported on stainless steel jacketed tanks, interconnected by pipe loops and an automatic control system supported by mean of PLC and SCADA was implemented at BIOCEN with the aim to replace the traditional sterilization of large volumes in autoclave. The prepared solutions for the formulation of parenteral products cannot be contaminated chemically and have to be sterile before aseptic processing. The validation of these systems is a requirement of the Good Manufacture Practices for Pharmaceutical products, since it is the way to prove that it is in accordance with the expected quality results. The performance qualification includes: qualification of the Cleaning in Place, Sterilization in Place, and Batch Sterilization in place, and the process simulation with culture media, are validation studies that must be carried out to demonstrate the reliability of the system. For the validation of cleaning, the composition of each solution, concentration of the chemical agent used, the temperature, the volume of water for injection and the time is considered. For the sterilization of the empty system and batch sterilization of the solution, the variables to take in considerations are temperature and time. The results demonstrated that the solutions remain sterile and there is no risk of cross contamination between the solutions of different composition. In addition, to confirm the previous results the process simulation with culture media was carried out. These results define that the solution preparation system is capable to reproduce sterilization cycles consistently.