Application Of High Voltage Pulsed Electric Field In The Non Thermal Sterilization Of Hollow Capsules

Vacant gelatin capsule is the main packaging material of capsule preparation.The main raw materials for vacant gelatin capsules are pharmaceutical gelatin,while gelatin is a kind of culture medium suitable for the growth of bacteria.Therefore,in the production process the gelatin capsules is highly susceptible to bacterial contamination,resulting in the excessive microorganisms of the hollow capsules.In this regard,the capsule production enterprises are mostly using ethylene oxide sterilization method to reduce the number of microorganisms,while the ethylene oxide has very strong toxicity,if excessive intake of human body,it is easy to acute poisoning events,long-term exposure to it,will have the cancer risk and teratogenic risk.According to Pharmacopoeia of People's Republic of China in 2010,the residual amount of ethylene oxide in the vacant capsules was not higher than 0.0001%.The existing production process can not meet the requirements of the pharmacopoeia,so a new type of production process is needed in the gelatin capsule production industry.Based on the Pulsed Electric Fields(PEF)technology,we studied its sterilization effect during treating gelatin and the changes of physicochemical properties of the colloidal solution after processing,designed a set of continuous sterilization device,and established a aseptic production process of vacant gelatin capsules.The research works on this paper conclude the following:It systemically reviewed and analyzed the production process of vacant gelatin capsules and analyzed the bacterial contamination of all the technologic processes.The results show that the melt adhesive glue process and the dip molding process is an important source of bacterial contamination,the glue pool in the process of dipping is an important place for microorganism propagation.It has explored the sterilization mechanism of high intensity pulsed electric fields technology and studied the influence of pulse electric field parameter on the sterilization of gelatin and the changes of physicochemical properties of the colloidal solution after processing.The results show that under the condition of handling capacity of 5m L,the pulse voltage intensity of 5Kv/cm,pulse frequency of 10000 Hz,pulse length of 6?s,processing time of 10 s,ambient temperature of 20?,adhesive temperature of 48?,the high voltage pulsed electric field sterilization process can can reach 97.78%,with the liquid gel viscosity unchanged.A set of on-line continuous sterilization device was designed according to the production process of vacant gelatin capsules and the sterilization effect of high intensity pulsed electric fields,the product of the vacant gelatin capsules was detected after treatment by continuous treatment device,the results show that the sterilization effect can reach 97.78%,equivalent with the effect of ethylene oxide on sterilization.After treatment,the physical and chemical properties of the capsule had no obvious change,the detection index could be stipulated in the 2010 edition of Chinese Pharmacopoeia.It has established an aseptic production process of vacant gelatin capsules.