Vhp Sterilization Pass Box

1. What is a VHP pass box?
2. VHP Pass box Components and Functions
3. Sterilization Principle and Process
4. Sterilizer performance parameters
5. Structure and Components of a VHP pass box
6. What is the workflow of the VHP pass box?
7. Sterilization Mechanism of VHP Passbox
8. Application scenarios of VHP pass box
9. Application scenarios of VHP pass box
10. What are the technical specifications of the VHP pass box?
11. Common sizes of VHP pass box
12. Common sizes of VHP pass box

Sterilizer performance parameters

1. What is a VHP pass box?

The VHP sterilization pass box is designed specifically for high-purity environments such as pharmaceuticals and scientific laboratories. It ensures an absolutely sterile environment and simultaneous sterilization when transferring items between different functional operating rooms.

2. VHP Pass box Components and Functions

It integrates an advanced hydrogen peroxide generator, a sterile air supply system, a PLC-controlled electromagnetic door interlock, a vacuum sealing system, a control system, and a vacuum sterilization medium dispensing system.

• First, the sterile air supply system utilizes a tank-sealed high-efficiency filter and a corrosi
• on-resistant, high-efficiency centrifugal fan to create a Class A cleanroom environment within the chamber.
• Second, hydrogen peroxide exhibits a powerful antispore killing ability at room temperature. By generating free hydroxyl radicals, it effectively attacks cellular components such as lipids, proteins, and DNA, achieving complete sterilization.
• Finally, the pass box’s sterilization chamber is a carefully designed vacuum-sealed enclosure, ensuring no leakage of the sterilization medium and complete isolation from the outside air. Furthermore, a specialized vacuum sterilization medium dispensing system ensures even H2O2 distribution, eliminating dead zones and ensuring optimal sterilization results.

3. Sterilization Principle and Process

Before sterilization begins, the clean air blower operates continuously, drawing in fresh air from the outside. This fresh air first passes through a fresh air filter and then a high-efficiency filter before entering the sterilization chamber for self-purification. The fresh air then circulates within the sterilization chamber through the return air duct, preparing for the subsequent sterilization process.

Once the sterilization process begins, the hydrogen peroxide dosing unit supplies liquid hydrogen peroxide to the hydrogen peroxide gas generator. This generator then converts the liquid hydrogen peroxide into a gaseous state and transfers it via piping into the sterilization chamber. Within the sterilization chamber, the gaseous hydrogen peroxide fully contacts the product, exerting its powerful spore-killing ability and achieving complete sterilization. After sterilization is complete, the system automatically activates the exhaust system to remove excess hydrogen peroxide residue generated during the sterilization process, ensuring a safe and clean environment.

4. Sterilizer performance parameters

When we deeply understand the performance of the sterilizer, we need to pay attention to a series of key parameters. These parameters not only affect the sterilization effect, but are also crucial to the safety and convenience of operation. The following are some core performance indicators:

• Power requirements: The sterilizer uses AC 220V/50Hz power supply to ensure stable power supply.
• Power: 2000W power to meet the needs of efficient sterilization.
• Dosing speed: Adjustable dosing speed, ranging from 1 to 3g/min, flexibly adapting to different sterilization needs.
• Carrier gas system: Use compressed air, the pressure is controlled at 0.3-0.6Mpa, and the gas flow does not exceed 6 cubic meters/hour to ensure safe and stable carrier gas.
• Vaporization temperature: The vaporization temperature is limited to 100℃ to ensure safe operation.
• Noise level: ≤70dB(A) to ensure a quiet and comfortable operating environment.
• Sterilizer: Use 35% food-grade hydrogen peroxide solution to ensure sterilization effect while also ensuring food safety.
• Killing rate: The killing ability for thermophilic fat spores reaches 6 log, ensuring efficient sterilization effect.
• Working mode: Supports manual or automatic working mode to meet different operating requirements.
• Sterilization cycle: The sterilization cycle is about 90 minutes, ensuring sufficient sterilization time.
• VHP concentration: During sterilization, the VHP concentration must be greater than 700ppm to achieve the ideal sterilization effect.
• VHP residual level: After sterilization, the VHP residual level should be less than 1ppm to ensure safe use.
• Chamber temperature and humidity range: The chamber temperature is maintained at 30℃~35℃, and the humidity is controlled at 40%RH~50%RH to provide suitable environmental conditions for the sterilization process.

The sterilizer also features real-time monitoring of chamber temperature, humidity, differential pressure, and VHP concentration. Data can be saved and printed using a convenient ribbon-type paper printer. It also includes door-open timeout alarms, door-lock alarms, and double-door interlocking, ensuring safe and convenient operation.

5. Structure and Components of a VHP pass box

A VHP pass box primarily consists of the following components: A main frame, a sealed door, a VHP generator, a heating system, a ventilation system, a control system, and a detection system.

• The VHP generator is the core component, generating VHP (vaporized hydrogen peroxide) gas.
• The heating system heats the liquid hydrogen peroxide to its evaporation temperature, converting it into a gaseous state.
• The ventilation system evenly distributes the VHP gas within the pass boxand controls its flow rate and direction.
• The control system operates and monitors the entire system, ensuring the smooth progress of the sterilization process.
• The detection system monitors the VHP gas concentration within the pass boxin real time to ensure the desired sterilization effect.

6. What is the workflow of the VHP pass box?

The workflow of the VHP pass box can be roughly divided into the following steps:

• Preparation stage: Place the items to be sterilized in a specific area of the pass box, close the sealed door, and ensure that the interior of the pass boxis in a closed state.
• Heating and evaporation stage: Start the VHP generator to heat the liquid hydrogen peroxide to the evaporation temperature and convert it into gas. At the same time, the ventilation system starts working to evenly distribute the VHP gas inside the pass box.
• Sterilization stage: When the VHP gas concentration inside the pass boxreaches the preset value, the control system will automatically enter the sterilization stage. At this time, the VHP gas will fully contact the surface of the items and destroy the cell wall and membrane structure of the microorganisms through oxidation reaction, thereby achieving the purpose of sterilization.
• Ventilation and discharge stage: After sterilization is completed, the ventilation system will continue to work for a period of time to discharge the VHP gas inside the pass boxto reduce its concentration to a safe level. At the same time, the detection system will continuously monitor the VHP gas concentration inside the pass box to ensure the safety and reliability of the discharge process.

7. Sterilization Mechanism of VHP Passbox

The sterilization mechanism of VHP pass box relies primarily on the strong oxidizing properties of VHP gas. When VHP gas comes into contact with microorganisms, it rapidly oxidizes biomacromolecules such as proteins, enzymes, and nucleic acids on their surfaces, destroying their cell walls and membranes. Furthermore, VHP gas reacts with water molecules to form reactive oxygen species (such as hydrogen peroxide and oxygen), which further damage the microorganism’s cell structure and accelerate its death. Therefore, VHP pass box achieve efficient and thorough sterilization in a short period of time.

8. Manufacturing process of VHP pass box(vaporized hydrogen peroxide pass box)

The manufacturing of VHP pass box involves multiple links such as mechanical structure design, sterilization system integration, clean control, safety protection and validation testing, and must comply with GMP, ISO 14644, FDA and other regulatory requirements. The following is its core manufacturing process:

1. Design and engineering planning

• Demand analysis
• Determine the purpose (pharmaceutical, laboratory, hospital?)
• Determine the sterilization level (such as 6-log spore killing)
• Select the size (standard/customized)
• Determine the control system (PLC/touch screen, whether data recording is required)

• 3D modeling and structural design
• Box material: usually 304/316 stainless steel (corrosion-resistant, easy to clean).
• Sealing design: ensure airtightness to prevent VHP leakage (silicone sealing strip + negative pressure protection).
• Double door interlock: prevent both doors from opening at the same time to avoid cross contamination.
• HEPA layout: high-efficiency filtration of air intake/exhaust (ISO Class 5 or higher).

1. Manufacturing and assembly of core components

• Boxprocessing
• Laser cutting/bending stainless steel plate → welding → polishing (Ra≤0.8μm, easy to clean).
• Install visual window (tempered glass, easy to observe).

• VHP sterilization system integration
• VHP generator: vaporizes liquid H₂O₂ (flash evaporation or atomization technology).
• Circulating fan: ensures uniform distribution of vaporized hydrogen peroxide.
• Catalytic decomposition module: decomposes residual VHP into H₂O+O₂ after sterilization.

• Clean air system
• HEPA filter (H14 grade, 99.995% @0.3μm).
• Fan speed control: maintains positive pressure in the cabinet (prevents external contamination from entering).

• Control system
• PLC/touch screen: set parameters such as sterilization time, concentration, temperature, etc.
• Sensor: real-time monitoring of VHP concentration, temperature, humidity, and pressure difference.
• Data recording: Complies with GMP ALCOA+ principles (traceability and tamper resistance).

• Safety protection
• Leak detection: Automatic alarm and emergency exhaust when VHP concentration exceeds the standard.

9.Application scenarios of VHP pass box

VHP (vaporized hydrogen peroxide) pass box are widely used in fields with extremely high requirements for aseptic environment, biosafety, and cross-contamination control due to their high efficiency sterilization, no residue, and rapid circulation. The following are its main application scenarios:

1. Pharmaceutical and biotechnology industries

• Sterile drug production (GMP workshop)
• Injections (water injection/lyophilized powder injection): transfer of raw materials, excipients, rubber stoppers, aluminum caps and other sterile materials.
• Biological preparations (vaccines, monoclonal antibodies, cell therapy products): prevent microbial contamination during the production process.
• Aseptic filling lines (BFS, vials): connect areas of different cleanliness levels (such as Class C → Class A).
• Biosafety laboratories (BSL-3/BSL-4)
• Transfer of experimental samples of highly pathogenic pathogens (such as Ebola, SARS-CoV-2).
• Ensure that pathogens do not leak out, in compliance with the “General Requirements forLaboratory Biosafety” (WS 233).

1. Medical and hospital systems

• Operating room and ICU
• Transfer of sterile surgical instruments and implants (such as artificial joints and heart stents).
• Reducing the risk of postoperative infection (SSI, surgical site infection).
• Sterile preparation room (IV preparation center)
• Transfer of high-risk drugs such as infusion bags and chemotherapy drugs across regions.
• Isolation ward (such as infectious disease hospital)
• Transfer of drugs/food for patients with HIV, tuberculosis, etc. to avoid direct contact between medical staff.

1. Scientific research and laboratories

• Cell culture and genetic engineering
• Transfer of cell lines and culture media to prevent mycoplasma/fungal contamination.
• Protection of stem cell laboratories and IVF (test tube baby) culture environments.
• Animal experiment facilities (ABSL-3)
• Transfer of samples from infected animal models (such as new coronavirus mice) to ensure biosafety.
• High-end cosmetics (sterile skin care products)
• Sterile transfer of raw materials (collagen, hyaluronic acid).

     10.What are the technical specifications of the VHP pass box?

11.A. Sterilization performance indicators

1. B. Cleanliness and airflow control

1. Structure and Materials

1. Control Systems and Safety

1. Environmental adaptability

1. Verification and certification requirements

11.Common sizes of VHP pass box