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Case Study: CSPC Megalith Biopharmaceutical

Case Study · Product Deep Dive

CSPC Megalith Biopharmaceutical · HVAC-Integrated VHP System

An engineered VHP bio-decontamination solution integrating the generator, HVAC system, fixed distribution piping and automated controls

Shanghai Fenggu Medical Equipment Co., Ltd. · Sterile Isolation & VHP Bio-decontamination Equipment
ClientCSPC Megalith Biopharmaceutical Co., Ltd. (Qinhuangdao mRNA vaccine manufacturing site)
IndustryBiopharmaceutical / mRNA Vaccine Manufacturing
EquipmentFGVHP1000 HVAC-Integrated VHP System
ApplicationSpace bio-decontamination of sterile areas, HVAC supply/exhaust ductwork and the area upstream of HEPA filters

Project & Product Overview

Shanghai Fenggu Medical Equipment Co., Ltd. supplied the equipment and engineered integration for an HVAC-integrated VHP bio-decontamination system. The project served CSPC Megalith Biopharmaceutical, deeply integrating VHP bio-decontamination equipment with the existing HVAC system, using its airflow circulation to distribute vaporized hydrogen peroxide through the HVAC ductwork into the target space.

The system performs space bio-decontamination across the entire sterile area, the HVAC supply/exhaust ductwork and the area upstream of HEPA filters, with automated control handling preparation, VHP injection, circulation and hold, aeration, and the return to production mode — reducing how often staff need to enter the cleanroom or move equipment.

Suited to: P2/P3 laboratories, aseptic formulation suites, biopharmaceutical production areas and other spaces requiring controlled bio-decontamination.

Fenggu FGVHP1000 HVAC-integrated VHP system installed at CSPC Megalith Biopharmaceutical
The FGVHP1000 HVAC-integrated VHP system, installed in the ceiling void and connected to the facility's HVAC ductwork.

How It Works: The VHP Bio-decontamination Mechanism

Vaporized hydrogen peroxide's strong oxidizing action disrupts the cell membranes, proteins and nucleic acid structures of microorganisms, giving broad-spectrum inactivation of bacteria, viruses and spores. After the cycle, the hydrogen peroxide breaks down into water and oxygen, with no toxic byproducts.

The system is designed and validated against a 99.999% (log-6) kill target; actual results are governed by the project's own validation protocol and reports.

System Components

  • Rotary dehumidifier: supplies a dry carrier airflow for the VHP process
  • HEPA filters: filter the process airflow entering the system
  • High-pressure blower: provides stable motive force for hydrogen peroxide vapor delivery
  • VHP vaporization unit: vaporizes the hydrogen peroxide solution and injects it under controlled conditions
  • CPVC tubing: carries VHP from the equipment to the HVAC system or target area
  • Integrated control system: integrates with the HVAC program to automatically switch between process stages
FGVHP1000 VHP generator, injection tubing and rotary dehumidifier at the CSPC Megalith Biopharmaceutical site
The FGVHP1000 VHP generator, injection tubing and rotary dehumidifier, installed at the Qinhuangdao project site.

Why an Integrated System

Compared with a mobile hydrogen peroxide sterilizer, an integrated system replaces "wheel the equipment into the cleanroom every time" with "fixed equipment, fixed tubing, centralized control." For a sterile area with multiple rooms, VHP can be distributed evenly through the HVAC system and distribution tubing, reducing the setup, positioning, dosing and removal work that multiple mobile units would otherwise require.

Equipment Setup

Mobile: each unit checked, dosed and wheeled into the area individually.
Integrated: fixed equipment and tubing, prepared centrally.

Vapor Distribution

Mobile: higher local concentrations can occur near each unit.
Integrated: distributed evenly to each room via ductwork.

Process Reproducibility

Mobile: placement can vary and affect the bio-decontamination outcome.
Integrated: blower frequency, airflow and valve states can be fixed.

Operational Handling

Mobile: staff must enter the area to wheel equipment out after the cycle.
Integrated: aeration and return to production are completed from the control panel.

The Automated Bio-decontamination Cycle

01 Preparation02 Dehumidification03 VHP Injection04 HVAC Circulation05 Hold06 Aeration07 Return to Production

Before starting, there is no need to wheel multiple units into the cleanroom one by one. VHP is injected through pre-installed tubing, and the remote control panel can be located in the HVAC control area. Once integrated with the HVAC program, the system can automatically complete preparation, circulation, aeration and the return to production — and after the cycle, staff do not need to gown up and enter the area to remove equipment.

Remote control panel and HVAC control computer used to operate the VHP bio-decontamination system
The remote control panel and program control, set up alongside the HVAC control station.
Internal structure of the FGVHP1000 HVAC-integrated VHP cabinet
Internal structure and functional units of the equipment.

Scalability & Project Value

An integrated system scales well. When a project spans multiple sterile areas, distribution can be handled through tubing and valves, with preset programs running automated bio-decontamination for each area in sequence. The system can also reserve VHP tubing and control interfaces for future facility expansion, so new areas are mainly connected by extending the VHP tubing and valve configuration — reducing the need to purchase duplicate standalone equipment.

Centralized

A single system manages equipment, tubing, valves and programs together.

Automated

Reduces manual handling, per-unit startup and in-cleanroom operation.

Consistent

Fixed airflow, valve positions and control logic improve process reproducibility.

Expandable

Reserved interfaces support future controlled-area expansion.

From Mobile Equipment to Systems Engineering

The CSPC Megalith Biopharmaceutical project illustrates an engineered approach to bringing VHP bio-decontamination equipment together with HVAC, fixed tubing and automated control.

Note: the project's actual bio-decontamination efficacy, cycle time and residual levels are governed by the formal validation documentation.
VHP injection tubing serving three sterile areas at CSPC Megalith Biopharmaceutical
Fixed VHP injection tubing, with one system serving three sterile areas.

An Illustrative Multi-Room Bio-decontamination Scenario

For example, a roughly 1000m³ Grade B sterile area with 12 rooms would typically require at least 3 mobile VHP sterilizers to cover the entire area using a mobile approach. With an HVAC-integrated VHP system, a single centralized unit paired with pre-installed tubing can complete VHP injection and coverage across the area.

Operation & Automated HVAC Integration

Before starting a cycle, the integrated system does not require each unit to be wheeled individually into the sterile area, unlike a mobile VHP unit. VHP is injected through pre-installed fixed tubing, the remote control panel can be located in the HVAC control area, and operators can complete the bio-decontamination work from the control station.

Once integrated with the HVAC system's program, the system can automatically complete preparation, VHP injection and circulation, aeration, and the return to production mode after the cycle. Once the cycle is complete, staff do not need to gown up again and enter the Grade B area to wheel mobile VHP units out one by one.

Labor, Local Concentration & Material Risk

When using multiple mobile VHP sterilizers, each unit must be checked and dosed with hydrogen peroxide solution before startup, requiring more manual preparation. While a mobile unit runs, higher hydrogen peroxide vapor concentrations can form near the unit; sustained or repeated local concentration spikes can increase the risk of corrosion to nearby materials such as sandwich panels.

An integrated system distributes hydrogen peroxide vapor to each room through HVAC ductwork and fixed distribution paths, which helps reduce local concentration spikes near the equipment and gives more even VHP delivery across the target rooms.

Process Reproducibility & Future Expansion

Mobile VHP bio-decontamination relies on manual placement and operation, and differences in unit position from cycle to cycle can affect the outcome. An integrated system injects VHP into each room through fixed ductwork, with parameters such as HVAC supply blower frequency, airflow rate and supply/exhaust damper position set to fixed values — helping improve the reproducibility of the process.

Where a project spans multiple sterile areas, a single integrated system can distribute VHP through tubing and valves, with preset programs completing automated bio-decontamination for each area in sequence. The system can also reserve VHP tubing and control interfaces for future facility expansion, so new areas are mainly connected by extending the VHP tubing, reducing the need to purchase duplicate standalone equipment.

Planning an HVAC-Integrated VHP System for a Multi-Room Facility?

Tell us your area layout and room count, and our engineers will recommend the right tubing and control configuration.

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