VHP sterilizer

NegotiableUpdate on 03/04

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

Online Consult

Overview

MBS transformed from an information service provider responsible for the pharmaceutical industry to a solution provider in 1993. MBS initially served as a link between the technical design department and the validation engineering department, as a subcontractor for the development and validation of VHP sterilization cycles. MBS, as an independent third party, directly or through suppliers, carries out the installation of production lines and the development and validation of VHP sterilization cycles for well-known pharmaceutical companies. VHP sterilization technology is very new, and MBS has been engaged in VHP cycle development since 1994, with over 14 years of experience in cycle development. We have close cooperation with many independent laboratories and biological indicator manufacturers, so we have a deep understanding of the latest regulations and cGMP guidelines, which enables us to calculate D values, perform LSKM testing, and determine segmented sterilization areas for cycles. Adopting MBS standards or customer guidelines and plans can effectively produce documents and execute cycle development.

Product Details

explain:
The TBM gasification hydrogen peroxide sterilizer has the characteristics of small size, simple design, and easy mobility, and is suitable for volumes of
Isolation system or clean room sterilization ranging from 1 cubic meter to 500 cubic meters. Automatic gas generator, produced through heating
The cubic meter of hydrogen oxide gas is evenly distributed on the surface of the object to achieve sterilization effect. (Test strain: Thermophilic Bacillus)
Isolation systems or clean rooms must be equipped with connection ports.
The sterilizer needs to be connected to the intended sterilization space through a connection port.
The sterilizer is placed outside the isolator or clean room.

The maximum consumption of hydrogen peroxide should not exceed 10 kilograms

Operating procedure:
Move the sterilizer to the intended sterilization location and connect the air inlet;
Turn off the air conditioning system (HVAC) or the intake system of the isolation system in the clean room;
Set up warning signs in the intended sterilization area to protect personnel safety;
Place a fan (or blower) at an appropriate location in the cleanroom to ensure even distribution of hydrogen peroxide gas;
Start the BioDecon system cycle;
Control the relevant cycle parameters through PLC and automatically run the program;
Introduce filtered clean air into the clean room or isolation system until the VHP concentration drops to a safe level;
After the cycle ends, manually check the VHP concentration to ensure personnel safety.

Validation/Periodic Sterilization Effect Inspection:
Adopting Siemens PLC S7-300 and Siemens touch screen.
Automatically control the temperature and humidity within the sterilization space.
Attached is a black and white printer (A4) that can print real-time periodic data reports or send data to the upper computer through LAN connection.
Automatic weighing and control of hydrogen peroxide consumption
Equipped with alarm function
The verification and sterilization effects are checked using biological indicators.