Aseptic transfer chamberGMP requires eye drops to be produced as sterile preparations, but the use of sterile production processes poses significant challenges for the sterilization of packaging materials such as empty bottles of eye drops. Due to the use of polymer materials (such as PE or PET) in packaging materials, only low-temperature sterilization methods can be used. Traditional low-temperature sterilization methods, such as EO and irradiation sterilization, are limited by sterilization processes and equipment characteristics and cannot be integrated into the sterile production process of eye drops. This device uses vaporized hydrogen peroxide sterilization technology to sterilize the inner and outer surfaces of eye drop bottles, which can achieve a sterility assurance level (SAL) of no more than 10-6 for the sterilized bottle body, and has the characteristics of low temperature, fast speed, and non toxicity.

Below, the editor will briefly introduce itAseptic transfer chamberThe characteristics are as follows:

During the emptying stage after the completion of biological decontamination, the air sent into the cabin is filtered through a sterilization filter to prevent the introduction of new pollution to the materials;

2. Using hydrogen peroxide vapor (VHPS) as a biological cleaning agent, which belongs to the low-temperature cleaning process and is environmentally friendly;

3. Adopting unidirectional multiple administration under high vacuum state, VHPS has better distribution uniformity during sterilization process;

4. Equipped with a data acquisition system, it can detect and print real-time data such as humidity and vacuum pressure inside the cabin.

5. There is a SIEMENS programmable logic controller (PLC) for modular control, which controls the entire process;

6. The inlet and outlet doors are double door structures with pneumatic sealing, pneumatic locking, and double door interlocking functions in working state, which can effectively prevent double door opening caused by personnel misoperation;

7. The interior is equipped with a trolley type sterilization bracket and its track system, which facilitates material loading and unloading;

8. Use vacuum pumping and sterile air replacement to evacuate hydrogen peroxide gas, ensuring a shorter sterilization process cycle;

Through the above content, we hope it will be helpful for everyone to understand the aseptic transfer chamber.