1. Reasonable design air purification system
Reasonable design and establishment of clean workshops and effective management are very important in pharmaceutical production. Through the design of walls, floors, pipelines, roofs, cement, lighting, ventilation, temperature and humidity, etc., the internal environment can meet the requirements of cleanliness. Through the three-stage filtration of air, the air entering the cleanroom meets the specified requirements, through the purification procedures of personnel and materials to isolate or eliminate external pollution, through the realization of parameters such as airflow organization, pressure difference and number of air changes, microorganisms and particles are inhibited pollution, it can exclude any quality damage caused by light, taste, relative humidity, etc.; through strict process discipline, to achieve the purpose of avoiding cross-contamination.
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 plans. Excessive pursuit of high cleanliness can sometimes bring heavy burdens to enterprises in terms of operation, maintenance and management.
The main characteristics of air purification technology in pharmaceutical production are:
* The air in the cleanroom should be purified and dust-removed to the specified requirements;
* The cleanroom should prevent microbial contamination and meet the inspection requirements for the number of colonies;
* Anti-explosion and anti-virus measures are required for cleanrooms using organic and toxic solvents. Generally, air conditioners do not return air and use fresh air.
2. Daily maintenance and management
Building a cleanroom and passing the acceptance does not mean once and for all. The production environment is a dynamic concept and is the result of the joint action of various environmental control measures. Daily maintenance, monitoring and management are essential. Generally speaking, cleanroom operation management includes cleanroom personnel management, item management, plant and equipment management, and cleanliness monitoring. 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. Reduced total airflow is one of the most common problems and is often caused by loose or worn belts that drive the fans. It is enough to reinforce and replace the belt, which can ensure the stability of the cross-sectional wind speed of the high-efficiency filter for a long time.
*Regularly clean or replace the filter bag in the air conditioning box. 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 large-sized dust particles will pass through the filter bag to reach the high-efficiency filter, shortening the life of the filter, and cannot guarantee the cleanliness.
* Strict rules. Various systems and regulations can only guarantee clean production if they are strictly followed. People are one of the most important sources of pollution. Therefore, every employee must start from himself, correct bad hygiene habits, and abide by the management system of the cleanroom.