Freeze Dryer: The "Fresh - Keeping Guard" in The Biopharmaceutical Field

Freeze Dryer: The "Fresh - keeping Guard" in the Biopharmaceutical Field

In biopharmaceutical production, the lyophilizer is a key equipment to ensure the activity and stability of drugs. By virtue of low - temperature freezing and vacuum sublimation technology, it can remove moisture while retaining the active ingredients of materials, and is widely used in the production of vaccines, enzyme preparations, antibiotics and other products.

When operating the lyophilizer, the three - step process of "pre - freezing - sublimation - desorption" must be strictly followed. In the pre - freezing stage, the temperature of the material should be reduced to below the eutectic point, usually controlled between -40℃ and -60℃, to ensure that the moisture is completely frozen into crystals. In the sublimation stage, it is necessary to slowly raise the temperature of the shelf and maintain a high vacuum environment (the vacuum degree is generally lower than 10Pa) so that the ice crystals can be directly sublimated into water vapor. In the desorption stage, the temperature is further increased to remove the residual bound water in the material. During the whole process, the intelligent control system of the equipment must be used to monitor parameters such as temperature and vacuum degree in real time to avoid the impact of parameter fluctuations on product quality.

Daily maintenance is crucial for extending the service life of the lyophilizer. After each use, the lyophilization chamber and cold trap should be cleaned in time to prevent residual materials from polluting subsequent batches. The oil level and oil quality of the vacuum pump should be checked every week. When the oil level is too low or the oil quality is turbid, it is necessary to supplement or replace the oil in time. The seals of the equipment should be checked every month. If the seal is found to be aging, it should be replaced immediately to ensure the tightness of the vacuum system. In addition, professional and technical personnel should conduct a comprehensive inspection of the refrigeration system and electrical system of the equipment every six months to ensure the stable operation of the equipment.

Compared with traditional drying equipment, the lyophilizer has significant advantages in retaining the active ingredients of materials and extending the shelf life of products. With the rapid development of the biopharmaceutical industry, lyophilizers with the characteristics of high efficiency and energy saving, intelligent control and strong compliance have become an important choice for pharmaceutical enterprises to improve production quality and efficiency.