GMP Sterile API Vertical Cone-shaped Vacuum Dryer Introduction
In the production process of APIs, both sterile drugs and non-sterile drugs will encounter the transfer of materials (crystals) during the production process. The common production process is: crystallization → filtration → washing → filtration → drying, etc. Process operation. In the past, the old process flow used in the production of APIs is: crystallization in crystal tank → solid-liquid separation by crystal filter or centrifuge → detergent cleaning crystal → vacuum filtration → manual discharge → tray loading, silk cloth bag covering A vacuum drying oven (or double cone drying) → manual discharging → raw material barrel. Among them, the material (crystal) in the process of transferring, due to the shovel in the crystal filter when shoveling the crystal or crushing the crystal cake Cracks will occur. In the process of discharging and digging crystals (powder) and placing them on the plate, the crystals are exposed for a long time, there are many man-made pollution factors, and the labor intensity is high. This old technology is difficult to meet the requirements of GMP for pharmaceutical production Claim.
The "three-in-one" (filtration, washing, drying) multifunctional equipment developed by Wuxi Shuangrui Machinery integrates solid-liquid separation, washing and filtration, and low-temperature vacuum drying of crystals. The above process operations are completed in a sealed container, which is effective To prevent man-made pollution and ensure the internal quality of drugs, the process flow is: crystallization of raw material drug crystallization tank → three-in-one multifunctional filter (filtering, washing and drying) and automatic discharge. This new operation has the characteristics of simple process, sealing operation, convenient material conversion, high production efficiency, and good product quality. The entire production process from the feeding of the crystalline solid-liquid suspension to the automatic discharge of the raw material after drying is completed in one container, which reduces the total number of API production equipment, which reduces investment costs and reduces the area of the plant. Because the "three-in-one" equipment has the above advantages, it has been gradually adopted by API manufacturers.
Sterile API Vertical Cone-shaped Vacuum Dryer Working Principle
"Three-in-one" equipment is to separate the solid-liquid mixture after crystallization in a closed container using the pressure difference before and after the filter cake as the driving force, and complete the filtration → cleaning → refiltration → recleaning → filtration in the same equipment Or press filtration → drying and other processes. Therefore, whether it is primary filtration or re-filtration after cleaning, it is filtration in the form of filter cake, that is, under a pressure difference as the driving force, the solid-liquid mixed suspension of crystals and liquid after crystallization is passed through the porous sintered mesh The plate makes the crystals (solid particles) be intercepted on the top of the filter medium, and the mother liquor (liquid) is separated through the medium.
Sterile API Vertical Cone-shaped Vacuum Dryer Big Advantage
1. The "three-in-one" equipment completes the mixing, filtering, washing, drying and other technological processes in the same closed equipment, thus avoiding the mixing of foreign matter and microbial contamination during the transfer of materials, so that the product quality is fully guaranteed .
2. Automatic control, convenient operation, reduced labor intensity, more stable process control
The "three-in-one" equipment can automatically perform crystal mixing, filtration, filter cake cleaning, crushing cracks, drying materials, and automatic discharge of materials. All operations such as hydraulic control are used to ensure stable operation.
3. With in-place cleaning and in-place sterilization functions
All parts in contact with the material can be fully automatically cleaned in place, including the body, pipes, pipe fittings, discharge valve, etc. After automatic cleaning, the parts can be sterilized in place without moving and disassembling the parts. , It is convenient to complete the cleaning verification of the equipment and the sterilization verification of the empty string.
4. The equipment structure is simple and the production environment is improved
The entire process of the "three-in-one" equipment from the beginning of the feed to the discharge of the finished product after drying is completed in one device, the total number of required process equipment is greatly reduced, and it plays the role of one at most conventional filtering equipment. Since the entire operation is carried out in a sealed state, no liquid, gas, or dust is discharged in the clean room, and there is no pollution and harm to the human body, thereby reducing the area of the clean area and reducing the total investment cost of the project.
5. Meet GMP requirements for API production equipment
The unit operations such as mixing, filtering, washing, crushing, deliquoring, drying and automatic material discharge are completed in the same equipment, which reduces and avoids possible environmental pollution to materials, reduces material exposure time, and ensures the internal quality of products , So that this type of equipment meets the requirements of GMP.
Sterile API Vertical Cone-shaped Vacuum Dryer Functions
1. Stirring and filtering function
The crystallized material (solid-liquid suspension) in the crystallization tank is stirred evenly, and then filtered for solid-liquid separation of crystals and mother liquor.
2. Filter cake cleaning and filtering function
It is also called the leaching or displacement cleaning of the filter cake. For materials that are easy to clean, the filter cake layer of crystals can be washed and filtered. For materials that are difficult to wash, the cake layer of crystals can be stirred and washed. The replacement cleaning and filtering of the agent can be done once or repeated several times until the cleaning is clean and the process requirements are met.
3. Deliquid extension function
The filter cake is crushed to remove the cracks in the filter cake, to overcome the disconnection phenomenon in the filter, and the air pressure or vacuum method is used to make the filter smoothly and the solid-liquid separation is clear.
4. Dry discharge function
After the low-temperature vacuum drying reaches the drying standard index, the material can be discharged automatically. During vacuum drying, the vacuum can be drawn from the top of the tank or from below the filter plate of the tank. At the same time, the jacket, stirring shaft and blades of the cylinder are filled with constant temperature hot water to heat the material to achieve the purpose of drying. After drying, turn on the stirring valve and discharge valve for automatic discharge.
5. CIP and SIP functions
After the process operation is over, the entire cylinder and the discharge valve are cleaned in place in the cylinder and the discharge valve cavity (rotating spray balls are installed inside) and then steam sterilized to complete the CIP and SIP function process .
The "three-in-one" multifunctional equipment of filtration, washing and drying produced by Wuxi Shuangrui Machinery Co., Ltd. absorbs the most advanced technology and makes bold innovations. It incorporates the world’s advanced clean equipment manufacturing technology and focuses on the structure. The research and development of bacterial product application is especially suitable for the preparation of sterile APIs.