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Cleaning Series (I) : Pharmaceutical industry, how should clean clothes be properly cleaned

Cleaning Series (I) : Pharmaceutical industry, how should clean clothes be properly cleaned

Cleaning Series (I) : Pharmaceutical industry, how should clean clothes be properly cleaned

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Nowadays, the quality and safety of drugs are concerned, clean clothes play an important role in the process of drug production. As enterprises have higher and higher requirements for clean clothes, cleaning of clean clothes has become an important part of recycling.

Cleaning of clean clothes can not be done in the traditional way. In order to avoid cross infection in the process of cleaning, baling and handling, the cleaning and management of clean clothes need to have strict operating norms and processes.
What are the necessary conditions for cleaning clean clothes?
1. Cleaning environment:
It is proposed in Appendix B7 of the Production Management Practice for Sterile Medical Devices (YY0033-2000) that
The air cleanliness level in the cleaning, drying and wearing of clean work clothes room and the end way cleaning and disinfection area of special station appliances can be one level lower than that in the production area. Article 5.1.16 of GB50457-2019 "Design Standard for Clean Workshop of Pharmaceutical Industry" requires that the air cleanliness level of clean work clothes washing, drying and finishing room should not be lower than grade D.
For example, Class B and Class C clean clothes can be cleaned in Class C, and Class B clothes can be washed, dried, folded, sterilized, packed and sealed before being transferred to Class B.
2, cleaning professional equipment: must use professional industrial washing machine and drying equipment; Clean clothes can be cleaned by stainless steel channel type dust-free special washing machine and clothes dryer, and the air used for drying must pass through HEPA filter.
3. Cleaning water: Generally speaking, the cleaning process of clean clothes uses treated sand filter water and pure water, and the rinsing process uses deionized water with a resistivity of at least 10 megms/cm; The cleaning water of clean clothes in dust-free purification workshop must be ultra-pure water, rather than ordinary industrial water. The final rinse shall be with filtered purified water and verified.
4, special detergent: detergent should choose non-ionic surfactants, PH value is neutral, to ensure the performance and service life of clothes.

The correct way of cleaning can not only effectively remove stains, but also protect the fibers of clothes and extend the service life of clothes.
In the cleaning process of clean clothes, the following points need to be paid attention to:
● Before cleaning clean clothes, should carefully check whether there is any damage, buttons, zippers and other accessories are intact; Defects should be repaired, replaced or discarded.
● Clean clothes, both new and old, should be selected first. If stains are found, stains should be removed before washing.
● Clothes in different clean areas should be cleaned separately.
"What is separate cleaning"? The basic principle of separate cleaning is: washing clothes for different purposes and in different areas should not affect each other and cross-contaminate each other. The "purification" of clean clothes mainly has two aspects: the purification of particles and the purification of microorganisms. The purification of particles is mainly realized through cleaning, and the purification of microorganisms is mainly realized through sterilization. After cleaning clean clothes, there should be no secondary pollution after whole clothes, transport, drying and sterilization.
● FZ/T 80014-2012 "General Technical Specification for Clean Room Clothing" requirements, washing water should be softened and filtered through at least 2.0μm membrane. Rinse with purified water at least 0.2μm filter membrane filtration. In order to limit the growth of microorganisms, UV sterilization devices should be installed in the water system.
● FZ/T 80014-2012 "General Technical Specification for Clean Room clothing" requirements, the drying temperature is recommended not to exceed 60℃, and then slowly cooling, to avoid fabrics by sudden shock. At the same time pay attention to prevent the dryer overload, should be according to weight or volume control drying capacity.
After cleaning, compared with other industries, the pharmaceutical industry's clean clothing processing process has an additional disinfection and sterilization procedure.

Sterilization methods of clean clothing include: 121°C high temperature sterilization, ozone sterilization, GAMMA ray sterilization, ETO sterilization, and usually the humid heat sterilization method in the 121°C high temperature sterilization method.
1. High-temperature sterilization at 121°C: Common high-temperature sterilization methods are divided into humid heat sterilization and dry heat sterilization. The difference is the sterilization mechanism. The principle of dry heat is the death of microorganisms through dehydration and drying which oxidizes, denatures, carbonizes proteins and poisons electrolyte concentration. The sterilization methods are the same, that is, both methods are physical sterilization methods using high temperature means to kill microorganisms, and some drugs are not suitable for sterilization by this method. In addition, after high temperature sterilization, clean clothes will have slight shrinkage phenomenon after the first two high temperature sterilization.

2. Ozone sterilization: The principle of ozone sterilization destroys the structure of microbial film by oxidation to achieve sterilization. Ozone first acts on the cell membrane, causing damage to the components of the membrane and resulting in metabolic disorders. Ozone continues to penetrate the membrane and destroy the lipoprotein and lipopolysaccharide in the membrane, changing the permeability of cells, leading to cell dissolution and death.

3. GAMMA ray sterilization: In the irradiation process, gamma ray penetrates the irradiated clean suit and acts on microorganisms, directly or indirectly destroying the ribonucleic acid, protein and enzyme of microorganisms, thereby killing microorganisms and playing the role of disinfection and sterilization.

4, ETO disinfection and sterilization: can kill a variety of microorganisms, including bacterial propagules, buds, viruses and fungal spores, is a wide range of universal sterilization agent. It prevents the normal chemical reactions and metabolism of bacterial proteins, which leads to microbial death.

As we all know, people are the biggest polluter of clean rooms. As an important tool to isolate particles from human body, the performance of clean clothing affects the environmental quality of clean room. In addition to the correct cleaning method, how to choose professional and appropriate clean clothes is the key point that pharmaceutical enterprises need to pay attention to.

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