TW-SC800 Sterility Transfer Cabin

Product Features

1. Sterility transfer cabin is automatically controlled by SIEMENS programmable controller (PLC), so as to control automatically the operation of equipment all stages, and ensure that the system works stably and reliably.

2. In the biological decontamination and exhaust stage, the air sent into the cabin is filtered through H14 HEPA filter to prevent the materials from being polluted.

3. It is equipped with independent ventilation and residue removal unit, including fan, pneumatic butterfly valve and exhaust pipeline, which can quickly replace hydrogen peroxide gas in the cabin and prevent it from entering HAVC system.

4. The feeding and discharging port adopt the double door structure, capable of realizing pneumatic sealing, pneumatic locking and double-door interlocking functions under operating conditions.

5. A cart-type material support and a track system are provided inside the cabin, so as to facilitate material loading and unloading.

6. The system functions in monitoring the temperature, humidity and pressure in the cabin in real time. It can be equipped with detection ports for concentration of hydrogen peroxide gas, dust particles and floating bacteria.

7. It is easy to verify this product. There are complete IQ, OQ and PQ documents, available for on-site verification.

8. It is capable of storingand printing the parameter data of biological decontamination cycle.

Technical Parameters

Cabin material: SUS 304

Grade of high efficiency particulate air filter: air supply HEPA: H14 Grade; air exhaust HEPA: H14 Grade

Alarm: high pressure and low pressure alarm/ overtime alarm for door opening/alarm for door locking

Biological decontamination cycle: ＜90min

Biological decontamination efficiency: ≤1ppm

Cleanliness in cabin: Class A

Hydrogen peroxide gas decontamination cycle interface: DN32 sanitary interface

Exhaust interface: DN50 sanitary interface

Dimensions: 100×80×200cm

Work area dimensions: 65×70×80cm

It is used for biological decontamination treatment of the outer surface of materials to avoid pollution caused by materials entering the A/B key areas from the non-grade areas/low-grade clean areas. Sterile transfer cabin can be used for all kinds of clean and dry items to be transferred in aseptic production, such as packaging materials, instruments, raw and auxiliary materials, accessories, environmental monitoring equipment, etc.

It is one of the most challenging operations to reduce or avoid microbial contamination and safely deliver materials (such as products, packaging materials, containers, etc.) to A/B grade aseptic production areas in the process of aseptic drug production. If the outer surface of the material entering the aseptic production area is not aseptic, the complicated and strict personnel entry procedures and environmental control requirements in the aseptic production core area will become meaningless.

On the other hand, the regulatory requirements and supervision of aseptic drug production will become more and more strict. The 2010 edition of GMP adopts a new classification standard for drug production environment (clean area), which makes it easy to destroy the A/B clean environment by using the traditional material transfer window, and the aseptic transfer cabin brings potential risks to aseptic production.

Email:sales-ratoone@ratoone.com
Tel : 008618857724224
Contact Person : Nina