Briefly describe the technical performance and verification of the dryer

During the drying process, the relationship between the temperature and pressure (vacuum degree) and other process parameters as a function of time is controlled and realized by the dryer according to the preset requirements. That is to say, in order to complete the drying of the product, the drying equipment (machine) needs to have corresponding technical performance. These performances are mainly as follows.

1 The drying box (shelf) cools, heats up and the uniformity of the shelf temperature.

2 cold trap cooling capacity.

3 vacuum system leakage rate and decompression rate.

4 The ability of the drying box to plug the machinery, the amount of suspension of the suspended shelf and the integrity of the piston rod guard.

5 in-situ cleaning and in-situ sterilization effectiveness.

6 other, such as the integrity of the air filter; the flexibility and reliability of the automatic control system; the reliability of the safety protection and fault alarm; the strength, rigidity and easy cleaning of the structure of the whole machine; the corrosion resistance of the inner surface material and Chemical compatibility with cleaning and sterilizing media, etc.

It must be pointed out that due to different varieties of products (such as pharmaceuticals, food or specimens), different shapes (liquid or solid), different shape and size, different production batches, different eutectic points, etc., the conditions and methods of heat and mass transfer It is also different. The process parameters (temperature, vacuum) required for drying are also different, so the technical performance of the dryer is also different. That is to say, dryers with different uses and design principles have different technical performance parameters. This book only takes the shelf thermal conductivity drug dryer commonly used in pharmaceutical drying as an example to introduce the main performance and verification of the dryer. All the verification work of the products in the production of drugs includes the identification of the plant, facilities and equipment, inspection and measurement verification, production process verification, product verification and other four aspects. As the main and core equipment in the production of drying drugs, the dryer should respond to the basic functions of the equipment and its technical indicators, the installation environment and the application of power supply, water supply, water supply steam, compressed air and other supporting facilities, as well as drying. The dry cycle process can reproducibly ensure the quality requirements of pharmaceutical production for identification and verification. The test data is used to verify that the dryer can operate according to production needs and operating limits. Provide a written basis for the user to accept the dryer, develop and review the calibration, maintenance, operation management procedures and operating procedures of the dryer.

The verification of the dryer shall include design verification of the main technical performance, manufacturing verification, installation verification, operation operation verification and verification of the drying product production process. Only the test or verification of the main technical performance of the dryer will be introduced here.

1 Manufacturer acceptance test. Its purpose is to verify the rationality and quality of design and manufacturing, and to provide test data for modifying the design and improving the quality of manufacturing and assembly to ensure that the dryer at the factory can meet the requirements specified in the ordering agreement.

2 user acceptance verification. The dryer is transported to the user for installation, and the environmental conditions of the installation site should be met (for example, when the sterile drug is dried, the clean room at the door of the drying box requires 100 clean air), power supply, water supply, and supply. Whether the facilities such as steam, compressed air, and drainage meet the design requirements for verification. Since the conditions of water and electricity used in the field are not exactly the same as those provided by the manufacturer during the test, the performance index of the machine will also change accordingly. Therefore, the main technical performance of the dryer should be verified for user acceptance and use. Provide basis for maintenance, operation management procedures, operating procedures, etc.

3When the user uses the dryer, or may have differences and influences on the quality of the product due to maintenance, adjustment, or changes in the parameters of the drying process, the corresponding performance shall be verified to ensure that the dryer can be produced. Meet production needs.