Product Specification

1400mm X 800mm X 2200mm VHP Pass Box In Biotechnology Industry

1. Purpose and Application:

   • The VHP Pass Box is a specialized equipment used in controlled environments, such as clean rooms, to facilitate the transfer of materials, equipment, or personnel between different zones or areas.
   • It is primarily employed in industries with stringent cleanliness and sterility requirements, such as pharmaceutical manufacturing, biotechnology, and healthcare.

2. VHP Sterilization Process:

   • The VHP Pass Box is equipped with a vaporized hydrogen peroxide (VHP) sterilization system.
   • During the transfer process, the pass box chamber is exposed to VHP, which effectively kills any microorganisms, including bacteria, viruses, and spores, present on the items being transferred.
   • This ensures the sterility of the materials being introduced into the clean room environment.

3. Design and Construction:

   • The VHP Pass Box typically features a robust, airtight, and non-shedding design, often made of stainless steel or other suitable materials.
   • It includes an inner chamber where the items are placed, and the VHP sterilization process takes place.
   • The pass box may have various features, such as interlocking doors, controlled airflow, and pressure monitoring systems, to maintain the required clean room conditions.

4. Operational Procedure:

   • The VHP Pass Box operation follows a specific protocol to ensure the integrity of the clean room environment.
   • This includes pre-cleaning the items, initiating the VHP sterilization cycle, and carefully transferring the materials through the pass box.
   • Strict procedures are in place to prevent cross-contamination and maintain the desired air quality and pressure differentials.

5. Maintenance and Validation:

   • Regular maintenance, including VHP system checks, filter replacements, and leak testing, is crucial to ensure the continued performance and reliability of the VHP Pass Box.
   • Periodic validation and certification processes are conducted to verify the pass box's compliance with industry standards and regulations, such as those set by regulatory bodies like the FDA or ISO.

Vaporized Hydrogen Peroxide

VHP Concentration - no specific concentration value is set, the smaller the better under the condition of meeting the requirements of sterilization

Temperature and humidity -- temperature rise does not exceed 5℃, humidity does not exceed 80%

Chamber pressure -- about 10-20Pa slightly positive pressure to prevent infiltration of air in background area

The vaccine industry is generally used for delivery:

• sterile gloves and eye masks;
• Sterile flask and lid;
• Aseptic medium; Record;
• Embryo eggs;
• Fermentation tank etc.
   

Laboratory animal room:
cage rack or animal transfer

VHP (Vaporized Hydrogen Peroxide) Decontamination Chamber is normally used for sterilization of outer surface of any object, which is not suitable for AUTOCLAVE & compatible with HYDROGEN PEROXIDE in vapour phase.

• Reserved foundation pit, equipment internal ground and ground level
• Door body multi-point fixed, high strength, no sagging
• Split window, chamber situation can be clearly seen
• If there is a dry/wet heat sterilization chamberet around, color steel plate isolation is recommended.

Operation Principle

Chamber air tightness test:JG/T 382-2012“Pass box”( - 500 Pa pressure maintaining 20 min,≤ - 250 Pa)
HEPA leak detection: in situ scanning leak detection can be done for high efficiency of air supply and exhaust
Cleanliness: static class A

It is equipped with PAO dust outlet and upstream concentration detection outlet, which can realize efficient scanning leak detection of air inlet.

Product Description

VHP Decontamination Chamber is designed for two different zone of area, for transferring of product from lower classified zone to higher classified zone (Non– sterile area to Sterile area), without effecting the balancing of respective zone, containment free product transfer to higher classified zone.

Characteristic & Features

• Sterilization process <120min. to realize multiple sterilization operations one day.

• Emergency Stop.

• Decomposition filter can effectively reduce the concentration of VHP remain Reduce the impact on environment and personnel.

• Very low hydrogen peroxide consumption.

Technical Parameters & Specifications

Engineering Drawing

Sterilization Process & Vaporizer Schematic Diagram

Production Line

1. There are 10 automatic welding machines, and 2 laser welding machines.
2. Full welding instead of spot welding.
3. Motor brand: Rosenberg, EBM, etc.
4. PLC brand: Siemens, Schneider etc.
5. Equipment verification support.

Validation Documents

• FDS
• DQ
• FAT
• I&OQ
• SAT
• PQ
• ……