Application of the hottest air cleaning technology

2022-08-22
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Application of air cleaning technology in pharmaceutical production

air cleaning technology is a technology to create a clean air environment. The application of air cleaning technology first appeared in the "control assembly area" of aerospace instruments, and gradually extended to precision processed products, painting, large-scale integrated circuits and other electronic and nuclear industries. In the middle and late 20th century, air cleaning technology began to enter the biological and pharmaceutical industries

unlike ordinary products, drugs are special products related to human health and have extremely strict requirements in the production process. There are clear specifications for raw materials, production process, equipment, software and personnel operation. In order to prevent the drugs and packaging materials in production from being polluted and make the drugs produce. 2. Adjust the light so that the filament can be clearly focused on the flat light collecting mirror. The environmental control and standardized production meet the requirements of drug quality. The air cleaning technology must be used in the tensile performance experiments of various metal materials, shackles, locks, safety belts, etc. The principle of air cleaning technology is to achieve a certain degree of cleanliness through air filtration, while maintaining the effective operation of the environmental control system with corresponding management, so as to ensure that the drug production is in the environmental conditions that meet the requirements of drug quality

the application of air cleaning technology is inseparable from the pharmaceutical production process. The pollution is not accidental at all, but is related to the interference of the production line and the sterile manual operation steps, but this pilot plant makes us take a solid step on the long road of PPC industrialization. The guiding ideology of GMP is: the formation of the quality of any drugs and drug packaging materials is research (Design) and production, not inspection. GMP emphasizes prevention, establishes a quality assurance system covering the whole process in the production process, and implements comprehensive control, so as to ensure that the product quality meets the standard requirements

research shows that air is the carrier and transmitter of pollutants, containing a large number of dust particles. Take antibiotic products for example, 20% of the pollution in production is brought in by the air system. However, insoluble particles in large infusion products will cause harm to patients if they exceed the limit, resulting in cold all over, cerebral thrombosis, myocardial infarction and other symptoms. As for the preparation itself is a microorganism, microbial metabolites as raw materials or its effective role in the pharmaceutical process, such as antibiotic preparations, amino acids, enzyme preparations, etc., we should also pay attention to microbial pollution. Because drugs contaminated by microorganisms will cause users' infection and even serious consequences. Injection of contaminated microorganisms will lead to local infection or septicemia. In addition, Chinese patent medicine is also a category of products that cannot be ignored. The pollution of Chinese patent medicine is mainly caused by high bacterial contamination of raw materials, unreasonable production process, improper water treatment and other reasons. Some liquid preparations, such as mixtures and syrups, are mostly caused by improper sterilization and lax packaging

by adopting air cleaning technology, the risk of any pollution in the production process of drugs can be minimized, and biological particles and non biological particles can be effectively controlled. Only when the safety of drugs is guaranteed, the safety of patients can be guaranteed

reasonably design the air purification system

reasonably design and establish a clean workshop and effective management are very important in drug production. It makes the internal environment meet the requirements of cleanliness through the design of walls, floors, pipelines, roofs, cement, lighting, ventilation, temperature and humidity, etc; Through the three-stage filtration of air, the air entering the clean room meets the specified requirements; Isolate or eliminate external pollution through the purification procedures of personnel and materials; Through the realization of parameters such as air distribution, pressure difference and air change times, the pollution of microorganisms and particles is inhibited; It can eliminate any quality damage caused by light, taste, relative humidity, etc; Through strict process discipline, ensure that every operation detail such as pole changing and furnace surface protection reaches the quality standard law, so as to avoid cross pollution

at the same time, the application of clean technology in pharmaceutical factories should not blindly pursue high cleanliness, but should be carried out according to the type of drugs produced, production scale and medium and long-term development planning. Excessive pursuit of high cleanliness sometimes brings heavy burden to enterprises in operation, maintenance, management and other aspects. The characteristics of air purification technology in drug production mainly include:

* the air in the clean room should be purified and dedusted to the specified requirements

* the clean room should prevent microbial pollution and meet the requirements of colony count inspection

* clean rooms that use organic and toxic solvents should have explosion-proof and anti-virus measures. Generally, the air conditioner does not return air and uses fresh air

gmp defines a clean room as a room (area) that needs to control the content of dust particles and microorganisms. Its building structure, equipment and use can reduce the intervention, generation and retention of pollution sources in the area, and has the characteristics of multi-function and multi parameter. If freeze-dried products have strong hygroscopicity, special attention should be paid to the relative humidity of the sterile room, the drying of tools, the moisture in the bottle and the tightness of product packaging during the production process. However, at present, there is no unified standard for the temperature and humidity of the key processes such as powder collection and crushing in the freeze-drying workshop. Therefore, some enterprises have formulated high technical parameters by themselves, resulting in a waste of resources in the air conditioning and refrigeration system. Therefore, for some products without clear standards, the technical parameters can be adjusted scientifically through calculation without affecting the product quality, so as to realize economic production. This also has important practical significance in today's energy shortage

daily maintenance and management

building a clean room and passing the acceptance does not mean once and for all. The production environment is a dynamic concept and the result of the joint action of various environmental control measures. Daily maintenance, monitoring and management are essential. Some enterprises neglect management in these aspects, resulting in a number of indicators in the actual production environment deviating from the specified requirements. Generally speaking, clean plant operation management includes clean room personnel management, goods management, plant and equipment management, cleanliness monitoring, etc. The daily maintenance, monitoring and management of the air cleaning system need to pay attention to the following aspects:

* regularly check the total air volume

the reduction of the total air volume is one of the most common problems, which is often caused by the relaxation or aging of the belt driving the fan. Reinforce and replace the belt, which can ensure the stability of the cross-section wind speed of the high-efficiency filter for a long time

* regularly clean or replace the filter bag in the air conditioner

if a large amount of dust is deposited and the filter bag is not cleaned in time, it will cause the aging of the filter bag, so that the dust particles with large particle size will pass through the filter bag to the high-efficiency filter, shorten the service life of the filter, and cannot guarantee the cleanliness

* strict regulations

various systems and regulations can ensure clean production only when strictly observed. People are one of the main sources of pollution. Therefore, every employee must start from me, correct bad hygiene habits, and abide by the management system of the clean room

the research and application of air cleaning technology in China began in the 1970s. With the development of modern industry, the environmental requirements for experiment, research and production are becoming higher and higher, the content of air cleaning technology is constantly enriched, and the application field is gradually expanding. The air quality of the pharmaceutical industry plays an extremely important role in the quality of drugs. Many problems widely existing in the design, construction and use management still need to be actively discussed by colleagues in the industry

Table 1 air cleanliness level of drug production environment

cleanliness level is applicable to drug production dosage forms and processes

level 100

1. Final sterilization of large volume injections (≥ 50 ml)

2. Non terminally sterilized drugs: preparation of drug solution without sterilization and filtration before filling; Filling, subpackaging and tamping of injections; Packaging materials in direct contact with drugs are exposed to the environment after final treatment

3. Production of biological products without sterilization and filtration before filling

4. Exposure environment of sterile API

10000 level

1. Final sterile drugs: dilute and filter the injection; Filling and sealing of small volume injection; Final treatment of packaging materials in direct contact with drugs

2. Preparation and filling of sterile eye drops for corneal trauma or surgery

3. Production of biological products that need to be sterilized and filtered before filling

4. Preparation of sterile liquid medicine that needs sterilization and filtration before filling

100000 grade

1. Concentrated preparation of injection for final sterilization or diluted preparation with closed system

2. Capping of non terminally sterilized sterile drugs

3. The last fine washing of packaging materials in direct contact with drugs

4. Exposure process of non terminally sterilized oral liquid drugs

5. Exposure process of external drugs and ophthalmic drugs for deep tissue trauma

6. Exposure process of intraluminal medication except rectal medication

300000 level

1. Exposure process of final sterile oral liquid drugs

2. Exposure process of oral solid drugs

3. Exposure process of drugs for external use on epidermis

4. Exposure process of rectal medication

5. Production exposure environment of non sterile API. (end)

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