Product principle

I.VHP technology vaporizes the liquid hydrogen peroxide into hydrogen peroxide vapor, which is then utilized to sterilize  object surfaces at low temperatures.

II.VHP exhibits broad-spectrum bactericidal properties and can effectively kill all types of microorganisms such as bacteria,  fungi, molds, viruses, and bacterial spores. Bacillus stearothermophilus is particularly resilient to VHP, thus serving as the  biological indicator for VHP sterilization validation.

III.VHP sterilization is non-toxic and residue-free. The vaporized hydrogen peroxide can quickly kill microorganisms during  the sterilization process and subsequently degrades into H2O and O2 after sterilization, resulting in a non-toxic and  residue-free environment. The residue concentration of hydrogen peroxide is detectable.

IV.VHP sterilization can be validated. A typical validation cycle comprises parameter development, VHP distribution study,  biological challenge test and exhaust degradation study. The TKSAGE-HPB VHP transfer box has a complete GMP validation  documentation system.

V.VHP sterilization has good compatibility. The TKSAGE-HPB series of VHP sterilizers utilizes a unique saturation control  method to prevent liquefaction or condensation of hydrogen peroxide throughout the entire sterilization process. This  ensures enhanced material compatibility.

Product structure

Equipment body

The VHP pass box features a main body constructed from stainless  steel, the inner chamber made of 316L# stainless steel. Additionally,  the frame and outer surface are made of 304# stainless steel. The  inner chamber is designed with rounded corners and a fully welded  structure, achieving a polished degree of Ras≤0.6μm.

VHP generation unit

The built-in dry VHP generator operates on the flash principle and  incorporates integrated control, ensuring uniform coordination with  the VHP pass box. This integrated control system facilitates more  stable regulation of VHP generation concentration, chamber  temperature, humidity and saturation.

Pneumatic sealing system

The compressed air power system governs the operation of both the inflatable seal and the pneumatic valve. These components  are controlled by a compressed air pipeline, including a pressure relief valve and a solenoid valve. The other compressed air pipeline adopts a separate pressure relief valve and solenoid valve for chamber saturation control.

Control system

The standard control system adopts PLC and HMI control modes with a standard modular control board, ensuring stable and  reliable operations. Additionally, the control system design has been validated and proven through practical application.

Purification filtration system

The chamber's air supply and exhaust are filtered using H14 HEPA filters, and the  process pipeline and chamber adopt purification design. When combined with a  high-efficiency filtration system, Class A purification can be achieved in the chamber. The equipment includes a dedicated test port that facilitates online testing and  verification of the purification conditions.

Electrical system

The design of the electrical cabinet adheres to the safety and protection regulations. The layout of electrical circuits is organized and reasonable, with clear markings for strong and weak currents that and comply with CE and EN standards.

EHS requirements

The product design prioritizes personnel and product safety by implementing  strong current safety protection measures to prevent operator contact with strong  current. Both sides are equipped with E-stop buttons. High-temperature parts are  clearly marked. Additionally, the chamber features an electromagnetic interlocking  device to prevent contamination of the product and cleanroom. Abnormal sound  and light alarm prompts are provided to avoid safety incidents.

Product specifications

Note: The above specifications are our standard products. For non-standard products, please consult with our  sales staff. This will enable us to provide you with non-standard customized products according to your requirements

Sterilization process

• Preheat: The chamber’s temperature and humidity conditions are automatically adjusted before the equipment starts to reach the set program start conditions.

• Balance: Sterilization conditions are activated, and the equipment performs self-balancing of VHP concentration and saturation to achieve sterilization conditions.

• Sterilize: Sterilization begins, accumulating the LOG value of sterilization until completion.

• Degrade: Following sterilization, the equipment enters the exhaust degradation stage for VHP residue discharge and degradation until the end of the program.

Standard procedure

LOGA program:

Using the D-value process control method for sterilized microorganism and LOG reduction value for sterilization, the  sterilization process is steadily adjusted to achieve the set sterilization conditions, which is generally set to 6LOG  program.

Concentration program:

The sterilization process is controlled by concentration and time, with the program established based on the sterilization concentration and time conditions obtained from the parameter development to achieve the set sterilization  conditions.

Introduction to common media

Verification system

The validation documentation system adheres to cGMP and Gamp5 requirements, and offers validation  documents and services spanning URS, FS, DQ, FAT, SAT, IQ, 0Q and PQ.。

Standard configuration

Optional

■ ASME BPE process pipeline: The process pipeline is made of 316L# stainless steel, providing welding logs and reports compliant with ASME BPE.

■ Audit trail: Utilizes Siemens audit trail module and authorization to meet FDA audit trail requirements.

■ Electronic signature: Includes an electronic signature function compliant with 21CFR Part 11, typically required for FDA standard items.

■ Bio-seal: Adheres to bio-seal requirements compliant with BSL-3 or BSL-4 for biosafety projects.

■ GMP validation (FAT, SAT, DQ, IO/PQ): Offers validation documents and services compliant with GMP upon request.

■ Spare parts kit: Includes parts and consumables for routine or regular maintenance of the equipment, such as inflatable seals, silicone tubes, VHP concentration probes, etc.

■ Loading trolley: The trolley is made of 304# stainless steel for transferring chamber loading brackets, which is easy to use.

■ VHP low-concentration probe: Installed in the exhaust duct to detect VHP concentration at the end of sterilization.

■ Clean-side operation screen: Enables dual-side operation and observation of equipment for ease of use.

■ TCP/IP network port: Facilitates electronic data transmission and connects the device to the SCADA system.

■ Venturi nozzle: Assists in distributing hydrogen peroxide inside the large chamber VHP pass box for improved distribution