Antioxidants Vitamins,Antioxidant Vitamins Tablets,Rubber Antioxygen,Antioxidants Free Radicals SHANDONG BAISHENG BIOTECHNOLOGY CO., LTD , https://www.baishengbioproducts.com Three key elements of lyophilization success
The composition of the solution is related to the implementation of steps such as freezing and sublimation.
The recipe includes:
Active ingredient; excipient; process water.
Second, important thermodynamic properties: (freeze drying process curve)
The degree of supercooling; the degree of crystallization; the disintegration temperature or eutectic temperature; the phase change of the metastable state interstitial material; the crystallization heat of the solution; the melting temperature of the interstitial material.
Third, the performance of the lyophilizer meets GMP requirements; excellent performance; energy adjustment; replay.
Introduction of three key elements of lyophilization success
First, the formulation of the formula is the most critical step.
After the formula is determined, the eutectic point temperature and the eutectic temperature of the product have been determined in a strict sense and determine the antifreeze and activity retention ability of the lyophilization process of the product in a certain sense.
Common brands in the market include: Beijing Bo Yikang, Shanghai Dongfulong, Hubei Chutian, Qianshan Far East, Shanghai Pudong, Beijing Suyuan and so on.
Advantages of Bo Medical Kang Vacuum Freeze Dryer:
u The small test and the pilot freeze dryer are of good quality and the performance has reached the international level.
u The production type freeze-drying machine focuses on bioengineering and preparation of traditional Chinese medicine, and the pharmaceutical freeze-drying supporting process is in the process of maturity.
u Refrigeration technology: cryogenic refrigeration technology, the cooling temperature can reach -165 .
u Efficient heat transfer technology: patented system flow technology, heat transfer efficiency can reach more than 95% .
u Vacuum diversion technology: system vacuum flow forced diversion technology, from the evaporation point to the water trap, the resistance is smaller and the water catching efficiency is higher.
u Manufacturing process of cabinet and lamellar : Strictly implement the manufacturing process standards of European and American cabinets, adopt internationally advanced laminating box manufacturing technology to ensure the pressure and leakage of the main structural parts of vacuum freeze dryer.
u International leading laminar temperature control technology (experimental vacuum freeze dryer): It adopts Japanese process standard heating material, and the uniformity per unit area can reach 0.1 °C. The temperature control algorithm uses fuzzy control + PID algorithm to ensure the control accuracy (other domestic manufacturers use a single PID algorithm, low control precision, easy to overshoot).
u Control system: The main models of the experimental vacuum freeze dryer adopt industrial PLC+ touch screen, and the stability and reliability are far superior to those of other manufacturers using single-chip + LCD or single-chip + touch screen.
u eutectic point test technology: 1000Hz alternating power supply is used to prevent electrolysis of test electrodes and affect test accuracy. Using the data recording hardware and data recording and data processing software of National Instruments of the United States , the analysis is performed in the mutation zone near the eutectic point temperature of the product to accurately calculate the eutectic point temperature of the product. For products without significant mutations, the system provides a mathematical model for analysis and calculation to derive the structure. Both offline and online test functions have been developed for customer needs. The eutectic point test function provided by the domestic vacuum freeze dryer manufacturer adopts the maximum resistance value of the product or the sudden change of the product temperature value as the eutectic point temperature discrimination basis. The results measured by the two methods are greatly deviated from the actual results. This method is suitable as a reference for the eutectic point temperature of the product, and cannot be used as an accurate material eutectic point temperature for scientific research or for accurate freeze-drying process.
u Online moisture testing technology: online weighing test using weighing method, high precision and consistency. Only some manufacturers in the same industry at home and abroad have this technology.
u Freeze-dried product activity protection technology: unique technology to optimize protein freeze-drying process and bacterial freeze-drying survival rate to help customers optimize the process.
u Manufacturing process: The manufacturing process is fully compliant with industry standards at home and abroad. Raw materials strictly enforce inspection standards. The internationally popular production process control method is adopted in the production process to ensure the consistency of product quality. The manufacturing process strictly implements ISO quality standards from process specifications to job guidance, from process inspection to type inspection .
u Quality control point control: For the important control points in the production process, the three-inspection system is adopted, and the important control points are specially staffed to ensure the stability of product quality.
Dongfulong vacuum freeze dryer advantages:
u Pharmaceutical freeze-drying supporting technology is perfect.
u Pharmaceutical freeze dryers are of high quality and have achieved international performance.
u The technology of small test and pilot freeze dryers is becoming more and more perfect, and it is developing in a small and intelligent direction.