[Overview] Sterilization is a key part of every aseptic pharmaceutical manufacturer and the focus of GMP inspection. The microbial exceeding the standard in the clean area directly affects the quality of the product, and the seriousness of the consequences is self-evident. The primary consideration for microbial excess is the presence of resistant strains in the clean area. The presence of resistant strains greatly reduces the sterilization effect and even disables the sterilization. Based on this, the author proposes solutions to the above problems based on the experience of foreign advanced killing strains.
[Keywords] pharmaceutical factory, clean area, resistant bacteria, killing method
Cause Analysis:
1. Long-term use of inefficient disinfectants. For example, quaternary ammonium salt compounds (QACs) have unsatisfactory effects on Gram-negative bacteria, especially Pseudomonas.
2. There is no reasonable disinfectant rotation. Some enterprises use disinfectant in a single way, and do not consider the complementarity of disinfectant efficacy; some companies have a disinfectant whose active ingredients belong to one type and do not play a role in rotation, such as two different quaternary ammonium compound rotations.
3. There is no disinfectant in the disinfection plan to kill spores.
The hygiene of the clean area is particularly important. The clean areas should be cleaned and disinfected as required in accordance with written procedures. There should be more than one type of disinfectant used. Environmental monitoring should be carried out regularly in order to detect the presence of tolerogenic strains and their spread in a timely manner.
Solution:
As the world's first purely ecological disinfection product, Norfolk is the first choice for GMP disinfectants in many pharmaceutical, beverage and food companies, both in the EU and in China. Because of the introduction of a high-quality and high-quality disinfectant quality, Norfolk has many years of experience in GMP disinfection, and can quickly customize the most economical and efficient GMP disinfection solution for customers.
Nofo brand disinfectant features Â
1 Efficient bactericidal ability: Norfolk can kill more than 200 harmful microorganisms including Escherichia coli, mold, and Salmonella, and even kill spores and some viruses. Therefore, whether it is a pharmaceutical factory, or a beverage factory, a food factory, Norfolk can be competent for the disinfection of the GMP workshop. We have a large number of test reports available on request.
2 High stability: Novo's test report in the Disinfection Center of the Chinese Academy of Military Medical Sciences (the only domestic testing agency that is qualified to test imported bactericidal products) clearly shows that at 54 degrees Celsius, the exposure is placed for 14 days, and the effect of Novoy is valid. The component loss is only 0.42%, which is the most stable among the known sterilization products. Therefore, the product can be effectively bacteriostatic while being efficiently sterilized.
3 High applicability: Norfolk is not affected by temperature, light and pH. This almost overcomes the shortcomings of all other disinfection products. We know that the current disinfection products will be affected by pH and temperature without exception. Thus failure or need to increase the amount (increased dosage means corrosive, increased concentration means that the GMP workshop is easy to clean)
4 Does not produce drug resistance: unlike chlorine dioxide and antibiotic products, Novo's unique sterilization principle does not produce resistance. Therefore, in the production of gelatin enterprises, the following two problems can be solved: 1) disinfection products use The amount will increase, there will be no increase in usage when using Norfolk. 2) The traditional disinfection product is ineffective or unstable after a period of use. Norfolk is the only product that does not produce resistance, so it can be long-term. , stable for GMP workshop
5 The world's first truly environmentally friendly bactericidal product: After the action, Norfolk decomposes into water and oxygen, does not cause any harmful residues to the environment, and the peroxide does not exceed the standard. It is diluted after a certain proportion of Norfolk, even Can be consumed directly. This is especially important for GMP workshops. The requirements for cleaning in the GMP implementation are very strict. One of the things that must be cleaned is the residue of the disinfectant. As a purely ecological disinfection product, the only residue of Norfolk is water and oxygen. , is the best choice for GMP.
6 Through the national and EU authoritative certification testing: Nuofu has the Ministry of Health imported products approval, EU food safety certification, EU ecological sterilization certification, and several national laboratory test reports, is currently the most qualified and authoritative GMP disinfection products.
7 Easy to use, easy to operate, standardized management
8 When used, it is colorless, odorless, non-corrosive, non-irritating (all reports from the Disinfection Center of the Chinese Academy of Military Medical Sciences), and does not cause any harm to the operating staff and the equipment in contact.
Conclusion: Nofo brand disinfectant sporicide specifically kills resistant strains and will not produce tolerance from now on, so you can safely use it safely, and you can also be a true clean and sterile area to provide a solid backing for the quality of the product. It is also the first choice for pharmaceutical companies to easily pass the new GMP certification. This product verification information is complete, without any worries.
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