Guidelines for disinfection of Pharmaceutical compant
Among the disinfection methods in pharmaceutical factories, many companies use the sterilization method of formaldehyde fumigation. Although this method is cheap and has excellent sterilization abilit...
Among the disinfection methods in pharmaceutical factories, many companies use the sterilization method of formaldehyde fumigation. Although this method is cheap and has excellent sterilization ability, but the disadvantages of formaldehyde are high toxicity, strong harm, inconvenient operation, and damage to the health of employees. and those are known and eliminated by more and more companies. Thus, the use of formaldehyde is prohibited in European pharmaceutical companies. This article integrates the latest technical solutions for environmental disinfection in the workshop of a pharmaceutical factory, and introduces the advantages of using dry fog hydrogen peroxide for disinfection in a pharmaceutical factory. Explain in detail why hydrogen peroxide can replace formaldehyde, and how hydrogen peroxide's bactericidal ability, corrosiveness, and residue are.
When choosing a sterilization equipment for a pharmaceutical factory, the following aspects should be considered:
1. Easy to use, simple to operate, eco-friendly, friendly to personnel and environment, and sterilization time is very short.
2. Bactericidal efficacy: it can kill Bacillus subtilis and Bacillus stearothermophilus up to log6.
3. Good material compatibility: no corrosion to metal, engineering plastics, rubber, clean room wall panels, epoxy resin self-leveling ground, high-efficiency air supply vents, return air vents, plexiglass, sockets, switches, various electrical display instruments .
4. No residue: to ensure that the sterilant residue after sterilization will not cause any form of pollution to the medicine.
5. Diffusion should be very good: full coverage, leaving no dead ends.
Development and advantages of dry fog hydrogen peroxide sterilizer
Dry fog hydrogen peroxide sterilizer has been applied to the disinfection of workshop spaces in European pharmaceutical factories for nearly 20 years. Especially in recent years, due to the restrictions on the use of formaldehyde space sterilization in the European Union, hydrogen peroxide dry fog sterilization has developed rapidly. For the first time, the concept of hydrogen peroxide sterilization was proposed for the workshop of a pharmaceutical factory. Although it cannot be quickly popularized in various categories, from the abandonment of formaldehyde sterilization and sterilization in the European Union, we have been able to see the entire industry, whether it is managers or participants. All of them are trying to find a product that can replace formaldehyde for sterilization.
1. Employee safety
Regardless of the industry, production safety is the first principle. Today, with the popularization of information, people are becoming more aware of the hazards of formaldehyde. Its hazards are mainly reflected in: strong carcinogenicity, strong teratogenicity, and intergenerational hazards (that is, pregnant women poisoning can cause fetal malformations). Therefore, we use a 7.5% concentration of hydrogen peroxide disinfectant. Its toxicity (LD) value is lower than that of table salt. and it is a recognized safe and environmentally friendly disinfectant and is widely used in pharmaceutical factories, hospitals, and pharmaceutical factories.
2. Application convenience
One of the characteristics of the pharmaceutical factory workshop is that the space is small and there are many emergencies. Therefore, emergency disinfection and small-scale disinfection are indispensable. Obviously, formaldehyde cannot cope with such emergencies. However, the dry fog hydrogen peroxide sterilizer is fast, wide, and flexible, which is very suitable for solving these situations.
Dry fog sterilization system verification system
The main verification content includes three parts:
1. Verification of sterilization effectiveness of dry fog hydrogen peroxide sterilization system
The sterilization effect of the atomized hydrogen peroxide sterilization system is verifiable. Through the challenge test of the biological indicator, according to the regulations in the USP, using Bacillus subtilis and Bacillus stearothermophilus as test bacteria, the decrease of 4-6 log units after sterilization can prove that the system is sterilized in space The ability to kill various microorganisms in the process.
2. Material compatibility verification.
3. Residual verification
After having a better sterilization agent, how to achieve a better space sterilization effect?
A basic understanding is that if the disinfectant can be vaporized, then the diffusibility must be ideal. This is what companies have always hoped for. However, if the disinfectant is ionized, the cost of the equipment and the use cost are very high, and many pharmaceutical workshops do not perform complete disinfection many times a year, so the cost performance is very low. However, the dry fog hydrogen peroxide sterilizer can solve these problems very well. Because of its good diffusion, and can solve more problems (such as dead ends, condensate, etc.), so as to meet the requirements of disinfection in the pharmaceutical factory workshop.
To sum up, because some insurmountable problems of formaldehyde fumigation are not accepted by the company, it is gradually abandoned by the company in production. Under the background that hydrogen peroxide sterilization technology is becoming more and more mature, the application of hydrogen peroxide for sterilization in pharmaceutical factories will be accepted and adopted. With its obvious advantages, this sterilization method will completely replace traditional formaldehyde fumigation.