Application of air cleaning technology in pharmaceutical production

Application of air cleaning technology in pharmaceutical production

Air clean technology is a technology that creates a clean air environment. The application of air cleaning technology has appeared in the "control assembly area" of aerospace instruments, and has gradually expanded to apply to precision processing products, painting, large-scale integrated circuits and other electronic industries, nuclear industry. In the mid to late 20th century, air clean technology began to enter the biological and pharmaceutical industries.

Unlike ordinary products, medicines are special products related to human health and have extremely strict requirements in the production process. There are clear specifications from raw materials, production processes, equipment, software to personnel operations. In order to prevent the contamination of pharmaceuticals and packaging materials in production, and to make the environmental control and standardized production of pharmaceutical production meet the requirements of pharmaceutical quality, air cleaning technology is indispensable. The principle of air cleaning technology is to achieve a certain degree of cleanliness through air filtration, and at the same time maintain 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 occurrence of contamination is not accidental at all, but is related to line disturbances and aseptic manual procedures. The guiding ideology of GMP is: the quality of any drug and drug packaging material is researched (designed) and produced, not tested. GMP emphasizes prevention, and establishes a quality assurance system covering the whole process in the production process. Full control is implemented to ensure that product quality meets the requirements of the standard.

Studies have shown that air is a carrier and a propagator of pollutants and contains a large amount of dust particles. Taking antibiotic products as an example, 20% of the pollution in production is brought in by the air system. In the case of large infusion products, if the insoluble particles exceed the limit, the patient may be harmed, and symptoms such as chills, cerebral thrombosis and myocardial infarction may occur. Microbial contamination should be paid attention to whether the preparation itself is a microorganism or a microbial metabolite as a raw material or participates in a pharmaceutical process such as an antibiotic preparation, an amino acid, an enzyme preparation or the like with an effective action thereof. Because drugs contaminated with microorganisms can cause infection or even serious consequences for users, injections of contaminated microorganisms can cause local infection or sepsis. In addition, proprietary Chinese medicines are also a type of product that cannot be ignored. The pollution of proprietary Chinese medicines is mainly caused by high raw material contamination, unreasonable production processes, and improper water source treatment. A liquid preparation such as a mixture or a syrup is often contaminated with excessive bacteria and is caused by improper sterilization and poor packaging.

By using air clean technology, the risk of any contamination of the drug during production can be reduced to a low level, effectively controlling biological particles and non-biological particles. Only when the safety of drugs is guaranteed, the safety of patients can be guaranteed.

Reasonable design of air purification system

Reasonable design and establishment of clean workshops and effective management are very important in the production of pharmaceuticals. Through the design of walls, floors, pipelines, roofs, cement, lighting, ventilation and temperature and humidity, the internal environment is cleaned; The three-stage filtration of air ensures that the air entering the clean room meets the specified requirements; the cleaning process of personnel and materials is used to isolate or eliminate external pollution; and the parameters such as airflow organization, differential pressure and number of air changes are used to suppress microorganisms and particles. Pollution; it can eliminate any quality damage caused by light, taste, relative humidity, etc.; through strict process discipline, to avoid cross-contamination.

At the same time, the clean technology application of pharmaceutical factories should not blindly pursue high cleanliness, but should be based on the type of drugs produced, the scale of production and the medium and long-term development plan. Excessive pursuit of high cleanliness sometimes brings a heavy burden to the company in terms of operation, maintenance and management. The main features of air purification technology in pharmaceutical production are:

Clean indoor air should be cleaned and dusted to the specified requirements;
The clean room should be protected against microbial contamination and meet the colony count inspection requirements;
Clean rooms using organic and toxic solvents should be explosion-proof and anti-virus measures. Generally, air conditioners do not return air and use fresh air.

The GMP specification defines a clean room as a room (area) that requires control of dust particles and microbial content. Its building structure, equipment and its use all have the function of reducing the intervention, generation and retention of pollution sources in the area. Multi-parameter features. If the lyophilized product has strong hygroscopicity, special attention should be paid to the relative humidity of the sterile room, the drying of the tool, the moisture in the bottle and the tightness of the product packaging during the production process. However, at present, there is no uniform standard for the temperature and humidity of key processes such as powder collection and crushing in the freeze-drying workshop. Some enterprises have developed high technical parameters on their own, resulting in waste of air conditioning and refrigeration system resources. Therefore, for some products without clear standards, the technical parameters can be scientifically adjusted to achieve economic production without affecting the quality of the products. This is also of great practical significance in today's energy shortage.

Daily maintenance and management

Establishing a clean room and passing acceptance does not mean that once and for all, the production environment is a dynamic concept and is the result of the joint action of environmental control measures. Daily maintenance, monitoring and management are essential. Some companies are negligent in management in these areas, causing many indicators in the actual production environment to deviate from the regulatory requirements. In general, cleanroom operations management includes clean room personnel management, item management, plant and equipment management, and cleanliness monitoring. The daily maintenance, monitoring and management of air cleaning systems requires attention to the following:

Check the total air volume regularly

The reduction in total air volume is one of the common problems of Zui, often caused by slack or aging of the belt that drives the fan. It is only necessary to 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.

Clean or replace the filter bag in the air conditioner regularly

Depositing a large amount of dust without cleaning the filter bag in time may cause the filter bag to age, so that large-sized dust particles will pass through the filter bag to reach the high-efficiency filter, shortening the life of the filter, and ensuring the cleanliness.

Strict regulations

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

The research and application of air clean technology in China began in the 1970s. With the development of modern industry, the requirements for the environment of experiment, research and production are getting higher and higher. The content of air clean technology is continuously enriched, and the application field is gradually expanding. The air quality of the pharmaceutical industry plays an extremely important role in the quality of medicines. For many problems that currently exist in design, construction and use management, it is also necessary for the majority of colleagues in the industry to actively explore.

The air cleanliness level of the pharmaceutical production environment is clean and applicable to the pharmaceutical production form and process.

Level 100:
1. Potting of large-volume injection (≥50 ml) of Zui terminal sterilization;
2, non-zui terminally sterilized drugs: no need to remove the sterilized solution before filling; preparation of the injection potting, dispensing and tamping; direct contact with the drug packaging materials after the final treatment exposed environment.
3. Production of biological products that have not been sterilized by filtration before filling;
4. Exposure environment of sterile raw materials

10,000 level:
1, Zui terminal sterilization drugs: injection of rare, filtration; small volume injection potting; direct contact with pharmaceutical packaging materials.
2. Sterile preparation and filling of corneal wounds or surgical eye drops;
3. The production of biological products that need to be sterilized and filtered before filling;
4, aseptic, pre-filling solution should be prepared by sterilizing and filtering.

100,000 level:
1. Zui's terminally sterilized injection is concentrated or diluted with a closed system;
2. The capping of the sterile drug that is not sterilized by Zui;
3. A fine wash after direct contact with the packaging material of the drug;
4. Exposure process of non-zui terminally sterilized oral liquid medicine;
5. Exposure procedures for deep tissue traumatic drugs and ophthalmic drugs;
6, the exposure process of the drug in addition to the rectal medication.

300,000 levels:
1. The exposure process of Zui terminally sterilized oral liquid medicine;
2. Exposure steps for oral solid drugs;
3. Exposure process for topical drugs for epidermis;
4. Exposure procedure for rectal administration;
5. Exposure to the production environment of non-sterile APIs.

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