Changzhou Yibu Drying Equipment Co., Ltd
Changzhou Yibu Drying Equipment Co., Ltd Take one step ahead in technology Take one step ahead in quality Take one step ahead in service.
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WPG -P Asepsis Pharmaceutical Spray Drying Machine ( Close loop Spray dryer )
(Asepsis spray Dryer)( Spray drying machine)
For decades, spray drying has been applied for powder production by the pharmaceutical industry – also under aseptic conditions. The ASEPTICSD Spray Dryer is perfect for the production of sterile pharmaceutical products such as vaccines, antibiotics and other products requiring aseptic conditions.
A precise control of the drying process gives far greater command over the shape, density and morphology of the final product than other aseptic drying technology, and moreover, with low running and capital costs, these advantages are obtained while reducing overheads.
Production of dry sterile dosage forms often involves mixing of the API with one or more excipients. To achieve a homogeneous mixture, the particle size distribution of the excipient(s) must match that of the API. In a one-step-operation, aseptic spray drying can turn a sterile solution into sterile particles of the required size with no risk of introducing impurities.
The spray dryers are also designed for handling organic solvents, which makes possible the use of a wide range of excipients within the formulation.
TheSterilisation using pure steam is the preferred and proven method within the pharmaceutical industry. For complex designs and where the product is in contact with the equipment surface, air pockets must be removed by applying vacuum. These challenging requirements are met by the new generation of YIBU ASEPTICSD Spray Dryers (patents pending).
Preface
The drying device with asepsis and spray is key equipment for manufacturing powder injection in pharmaceutical industry. Many antibiotics, such as streptomycin sulfate, gentamicin sulfate, kanamycin sulfate and so on, need the drying device with asepsis and spray to manufacture during the process of production.
In the system of the drying device with asepsis and spray, all raw materials and air entered into the system must sterilize. The collect of product should be carried out in the asepsis chamber. Therefore the spray liquid can be transferred to the sprayer after it is sterilized. The compressed air can be used after purification too. (The above mentioned two items should be completed by customers.)
The air used for drying should be purified through primary and middle effective filters, blower and high effective filter. Then the purified air is heated through heater and transferred to the dryer. The dried finished products and air are separated through cyclone separator. The finished products should be packaged at the working table in asepsis room. The tail air is discharged through filter.
Feature :
The device adopts sprayer with two ways of flow. Its features are simple in structure, good in contact of flow, uniform in atomization. The requirement of asepsis spraying can be reached.
There is cleaning system in the tower, it’s easy to clean the powder on the inside wall of tower.
Because the hot air passes through the primary and middle and high effective filters, the purified quality of air is high. It is in conformity with the requirements of GMP.
It is very convenient to carry out control and management The electronic systems and their safety should comply with the requirements set forth in 21 CFR Part 11 and GMP Annex 11;
The data should be collected at appropriate time intervals and stored in the system in a fixed format that can be printed out/read;
through filter.