2010 GMP claims that the production of ophthalmic preparations should be in accordance with sterile preparation. The use of sterile production process brings big challenges to the sterilization of packaging materials such as bottles of eye drops. As the polymer material (such as PE or PET) the packaging used can only be dealt with low temperature sterilization, while traditional low temperature sterilization methods, such as EO or radiation sterilization can not make this sterilization process integrated into the sterile production process of eye drops because of the sterilizationprocess and equipment features. To solve this problem, Tailin developed sterilizing equipment for eye drops bottles - STP2000V VHPS Vacuum Sterile Transfer Passageway.
STP2000V VHPS Vacuum Sterile Transfer Passageway use vaporized hydrogen peroxide sterilization to sterilize inside and outside surface of eye drops bottles, which enables the sterilized body to reach the level no higher than 10-6 sterility assurance level (SAL). This method is fast, non-toxic and can work under a low temperature.
1) Using hydrogen peroxide vapor (VHPS) as a biological detergent, which can be operated under low temperature and atmospheric conditions, is efficient and environmental-friendly.
2) Sterile Transfer Passageway is controlled by a SIEMENS programmable logic controller (PLC);
3) Using one-way multiple doses under a high vacuum state. VHPS has better uniformity during sterilization;
4) Using vacuumizing and overall replacement to empty hydrogen peroxide to ensure the shorter sterilization process cycle;
5) In the emptying phase after the completion of biological decontamination, air fed to the cabin should be sterilized by sterilizing filter, in case that new pollution is brought to material;
6) Double swing doors with pneumatic seals, pneumatic locking and two-door interlock in the working status.
7) Sterile Transfer Passageway interior are designed with transportable material supports and track system, which make it convenient to load and unload materials;
8) With a data acquisition system, the data of humidity in the cabin and the vacuum pressure can be real time detected and printed out.