The control of cleanliness level of sterile drug production workshop is an important part of quality assurance of drug production, and space sterilization is an important means to ensure the cleanliness level of clean area. The following three sterilants are commonly used for space sterilization: ozone, formaldehyde, and vaporized hydrogen peroxide (VHP).

VHP Sterilization Advantages

The space sterilization of sterile pharmaceutical production workshop is more important with the improvement of GMP requirements. The traditional formaldehyde fumigation has gradually faced elimination due to its toxicity, while ozone is not suitable for space sterilization due to its poor sterilization ability. Vaporized hydrogen peroxide is non-toxic and harmless to human body, with short stopping time and strong sterilization ability, so it has become the best choice for space sterilization in pharmaceutical factories.

From US Pharmacopoeia 1072 Disinfectants and Antimicrobial Agents 

In the US Pharmacopoeia 1072 Disinfectants and Antimicrobial Agents, gaseous ozone is classified as a sporicide only at 80,000 ppm, and vapor hydrogen peroxide is classified as a bactericide at 4 ppm. 

Relevant definitions in the US Pharmacopeia:

Sporicidal agent: An agent that destroys bacterial and fungal spores when used at sufficiently high concentrations for a specified contact time.

Fungicide:An agent that destroys various microorganisms (including fungi, viruses and various forms of bacteria and their spores).

Excerpt from EU GMP Appendix 1 Sterile Drug Manufacturing - Version 2022 

In the EU GMP, it is clearly proposed that vaporized hydrogen peroxide can be used for cleanroom fumigation and disinfection. 

VHP Space Sterilization Equipment 

Our space sterilization equipment is divided into two types, integrated air-conditioning type and mobile type, according to the different ways of VHP steam diffusion. 

 Integrated VHP Sterilization System 

Equipment principle: VHP generating equipment is integrated into the air conditioning system, and the air conditioning system is used to transmit and diffuse hydrogen peroxide vapor so as to achieve space sterilization of the target environment, with a maximum sterilization capacity of more than 1000m³. 

  Mobile VHP Sterilizer   

Equipment principle: small movable equipment, no need integrated air conditioning system. The equipment is pushed into the target environment before sterilization, and the equipment adopts the top spiral air supply design, so that the hydrogen peroxide steam is evenly distributed to the whole target space, and the theoretical sterilization volume can be more than 500m³.

Core Advantage - Dry Sterilization 

SHINVA ensures complete vaporization of hydrogen peroxide through an advanced vaporization control scheme to achieve dry sterilization, which has two major advantages as follows: 

1. Better sterilization effect and short sterilization time

The sterilization principle of vaporized hydrogen peroxide is to generate free hydroxyl groups for attacking cellular components, including lipids, proteins and DNA, thus destroying microbial tissues with a killing capacity of up to 10-6. Vaporized hydrogen peroxide sterilization has a small D-value and a short sterilization cycle, thus improving the efficiency of pharmaceutical plants. 

Test microorganisms

D Value(minute)

Time required to kill 90% of Bacillus 




Bacillus thermophilus


Bacillus subtilis


Bacillus subtilis 


2. Better security

True dry sterilization with less corrosive, better material compatibility and no damage to colorful steel plates and all kinds of equipment in the clean area. 

Features of the Integrated VHP Sterilization System 

1. The fully vaporized hydrogen peroxide vapor can effectively pass through the high-efficiency filter, thus making full use of the air conditioning system for transmission and diffusion, and achieving uniform distribution of hydrogen peroxide vapor in the target space.

2. SHINVA uses professional engineering plastic piping to transmit VHP steam from VHP generating equipment to air conditioning system. The engineering plastic piping has low thermal conductivity and good temperature and corrosion resistance. The engineering plastic piping is externally heated and insulated to ensure no condensation loss of VHP steam in the piping.

3. Centralized control of air conditioning system with one key sterilization. Support SCADA data collection with audit trail function.

Features of Mobile VHP Sterilizer 

1. The completely vaporized hydrogen peroxide steam is sent through the spiral air supply at the top of the equipment, which makes the hydrogen peroxide steam far away from the return air outlet of the equipment, maximizing the diffusion capacity of hydrogen peroxide steam and achieving uniform distribution of hydrogen peroxide steam in the target space.

2. Adopt Ipad remote operation, personnel can realize the monitoring and operation of the equipment outside the sterilization area. The equipment runs automatically and the sterilization process does not require human intervention.

3. The equipment is equipped with a pin printer and Siemens screen, with electronic signature, electronic record, audit track and other functions.

For Health, Be Credible. By virtue of its strong R&D capability, SHINVA has created a perfect product system, which not only develops sterilization equipment for clean area space, but also develops VHP sterilization transfer window for sterilizing the external surface of moisture and heat fearing items, which is suitable for transferring items from low level clean area to high level clean area, thus reducing the pollution to high level clean area.

As a leading manufacturer in the pharmaceutical sterilization in China, SHINVA is providing the best space sterilization solutions for clean spaces including production areas, production equipment, transfer windows, isolators, etc. in pharmaceutical plants through unremitting innovation.