A new method for replacing formaldehyde fumigation sterilization in pharmaceutical factories - dry mist sterilization system

A new method for replacing formaldehyde fumigation sterilization in pharmaceutical factories

Author: Zhong Chengrui

[Overview] At present, the sterilization of most pharmaceutical factories in the clean area is based on formaldehyde fumigation. With the development of social economy and the improvement of safety and health production requirements, formaldehyde is increasingly not suitable for the safe and healthy production requirements of enterprises. The pharmaceutical industry's search for new harmless and friendly sterilization methods to replace formaldehyde fumigation will become an inevitable trend in the future.

[Keywords] pharmaceutical factory, replacing formaldehyde, formaldehyde fumigation, sterilization, sterilization new method

Formaldehyde (molecular formula: HCHO), also known as formic aldehyde, is the simplest aldehyde, usually a flammable, colorless and irritating gas. Soluble in water, alcohol and ether. 35 to 40% of the aqueous formaldehyde solution is called formalin. When the concentration of formaldehyde reaches 0.06-0.07mg/m3 per cubic meter of air, children will have mild asthma; when it reaches 0.5mg/m3, it will irritate the eyes and cause tearing; when it reaches 30mg/m3, it will immediately die. .

Formaldehyde Health Hazard: IARC's carcinogenicity review was once "animal positive; humans are not clear", and after further research, was identified as a Class 1 carcinogen in 2006 (ie, carcinogenic to humans and animals - "sufficient evidence of carcinogenicity "). Formaldehyde has an irritating effect on the skin and mucous membranes. Allergic skin may be exposed to formaldehyde. In severe cases, it may cause hepatitis, pneumonia and kidney damage.

Is there a new sterilization method that can replace formaldehyde fumigation? Here to tell everyone a good news, the answer is yes.

After many years of experience and exploration in the pharmaceutical industry, our company has introduced a set of methods that can completely replace formaldehyde fumigation. The modification method is the Orpheum Dry Mist Hydrogen Peroxide Sterilization System, which is already mature in the European Union and is an EU GMP approved product.

The dry mist sterilization system in the pharmaceutical clean area mainly uses physical means to convert the liquid sterilizing agent (main component hydrogen peroxide + active colloidal silver ion) into a "dry mist" in an aerosol state, allowing it to be dispersed in the need of sterilization. The sterile cleansing area, in order to achieve a thorough sterilization effect, can replace the existing formaldehyde fumigation.

Dry fog has the following properties:

1. Dry mist droplets carry out irregular motion (Brown motion principle) and will not settle;

2. Dry mist droplets do not aggregate together to produce large droplets;

3. The dry mist will rebound after contact with the surface without rupturing and moistening the surface;

Therefore, these properties of the dry mist gas make it difficult to achieve a good sterile clean area and surface sterilization effect.

Advantages of dry mist sterilization system:

1. The sterilizing agent can be controlled to be sprayed in the form of dry mist. The size of the dry mist particles is controlled at a precise and consistent level, which reduces the risk of condensing liquid and ensures the penetration and disinfection effect on the more complicated and difficult to reach.

2. Can effectively reach all areas of the clean area.

3, the external structure is sturdy, maintenance is simple, no power is required for work.

4. The main components are made of 316L stainless steel and can be sterilized at high temperature.

5, a single machine can be used for disinfection of 20-1000m3 sterile clean area.

6. The entire disinfection process takes a short time, so the shutdown time is greatly shortened compared to formaldehyde fumigation.

7. There is no noise or ultrasonic pollution throughout the disinfection process.

8, strong sterilization effect, complete verification data, cost-effective.