Rapid Bio Decontamination Cycle Sterility Isolator Hydrogen Peroxide Vapor For Cosmetic

rapid bio decontamination cycle ss304 sterility isolator hydrogen peroxide vapor for cosmetic

For some special products, especially those with high toxicity, high activity and poor stability, the sterile isolation cover from the environment to the isolator needs to provide a simpler and faster delivery, and minimize the processing time of the drug in the device. In addition, with the increase in the production speed of pharmaceutical production equipment, the supporting aseptic isolator also needs to be adapted to achieve a good coordination effect.

At present, the new type of isolator uses a high concentration of hydrogen peroxide solution spray directly into the sterile isolator transfer window. Compared with the conventional method of heating atomized hydrogen peroxide, the method is more direct and rapid, and the whole process can be 10~ Completed within 15 minutes, greatly improving the transfer speed of the product. For high-volume material transfer, the new E-beam sterilized tunnel can be used in conjunction with a sterile isolator to produce ultra-high-speed products, such as 10,000 to 20,000/h pre-filled syringes. Production speed.

The improved performance of the aseptic isolator air handling system also guarantees an increase in isolator sterilization speed. Early isolator air handling systems were similar to cleanrooms and were slower. With the development of isolator technology, the air conditioning system for the isolator is equipped with a faster inlet and outlet unit and a separate temperature and humidity adjustment device, all of which provide a guarantee for improving the processing speed of the isolator.

In addition, the new isolator is equipped with a special disposable hazardous substance filter that separates the traditional air treatment high efficiency filter from the hazardous substance treatment filter. The hazardous substance treatment filter is specially sealed, disposable, and replaced separately. The safety of the sterile isolator is further improved.

1. The first generation: soft materials such as PVC as the main structural material, the air treatment system is designed as a turbulent structure; the operating parts are mainly gloves/sleeve components, half-length suits, and controlled by ozone or peracetic acid. The mainstream means of microbes.
2. The second generation: With the development of aseptic isolation technology and sterilization technology, the aseptic isolator developed into a stainless steel material as the main structural material, but the structure still retains the turbulent flow design in the cabin. The sterilization method is mainly based on a hydrogen peroxide device connected to an external vaporization or spray.
3. The third generation: In order to strengthen the risk control during the use of the sterile isolator and based on the occupational health considerations of the operators, the aseptic isolator develops into a stainless steel-based material, a unidirectional flow design, an integrated online environmental monitoring device, and vaporization. The hydrogen peroxide sterilization system is integrated with the isolator. With electronic signature and electronic record requirements, it achieves regulatory requirements for data integrity such as disaster recovery and audit trails.

Parameter

An important issue in aseptic isolation techniques is how to reduce the effect of residual hydrogen peroxide in the separator on product stability. Conventionally, it is common to introduce a large amount of sterile air into the barrier and to reduce the amount of air hydrogen peroxide in the separator as much as possible by the exhaust process. Current separators can achieve a reduction in hydrogen peroxide concentration to a level of 10-6 or even lower, in which case subsequent batches of product will be exposed to lower concentrations of hydrogen peroxide if continuous production is performed.

Isolator manufacturers are now investigating very low concentrations, such as the effect of hydrogen peroxide on different products at concentrations ranging from 1 to 30 x 10-8, as well as packaging materials used in the production of products, such as vials and cards. The absorption status of hydrogen peroxide in the bottle. It is believed that the results of these studies can further expand the scope of application of sterile isolators and further improve the quality of products.