Compared to the traditional, batch process, which still dominates the pharmaceutical industry, continuous production of drugs and medical products offers a number of advantages when it comes to production output. Moreover, it is a crucial factor in improving product quality and process development through continuous and detailed evaluation of product data. Unlike batch production, a continuous production system can significantly reduce production costs, shorten production times and significantly increase overall efficiency. Our client is a globally renowned pharmaceutical manufacturer with several production sites in Germany. With the new production facility, our client managed to achieve a technological milestone in continuous production in the pharmaceutical industry.
Project Description
To ensure a controlled and safe transfer of container products, a GMP-compliant raw material supply system was implemented in two production lines to feed the continuous mixing system (CMT). Additionally, a continuous dosing function was installed.
According to the main requirements of our customer, the system had to be dust-free (up to OEB 3) and offer high availability of the installation, as well as an automatic CIP cleaning function (Cleaning in Place). With a focus on sustainability and Industry 4.0, emphasis was placed on fully automatic integration into the overall process, as well as on the energy efficiency of the systems used and regional processing and production.
Process Step 1
After inspecting the incoming goods, the FIBCs with various active pharmaceutical APIs are transported to the five unloading stations of the plant partners, each divided into two rooms. In principle, the unloading stations consist of four main components:
- The connection system is the core for a safe and dust-free connection of the FIBC. The product to be unloaded is discharged gravimetrically into a suction shoe, which forms the interface for the next process step.
- A support table minimizes the weight of the FIBC and is used to secure the handling of suspended loads.
- A massage system optimizes the unloading process and is particularly suitable for poorly flowing or bridging products.
- The corresponding frame is necessary for the safe mounting of the connection system and the FIBC cover. A pneumatic clamping system is used for securing the FIBC outlet. Depending on the application area, working height, and installation dimensions, there are various additional options.
- A rail with a chain hoist and loading device is required to safely lift the FIBC and place it on top of the connection system for unloading.
A special feature of this project was the five-part cantilevered frame consisting of three complete portal units with two cross braces. This unique custom construction led to significant cost savings during the production process and simplified assembly in tight spaces. The discharge system (AAS-EF) is used for dust-free discharge via a two-lever mechanism to prevent the risk of pinching.
The integrated dedusting filter separates dusty and dust-free air (clean gas side) and prevents product from entering the clean gas side or the extraction unit.
An additional inline sieve with a protective sieve prevents impurities and avoids foreign contamination. A mobile transport cart allows the connection system and suction shoe to be quickly and easily transported to a separate washing room for wet cleaning.
Process Step 2
Transporting to the next process step is generally a difficult task in solids technology from an integrated weighing system in bulk. Operator protection and avoiding cross-contamination are the highest priorities. After dust-free unloading of the FIBCs, the products are transported to the next room using a pneumatic conveying system (PCC) and a fluid-optimized and specifically adapted piping system.
In total, 10 Plant Partner ProClean Conveyors (PCC) were implemented for the safe and smooth handling of powders and granules. Depending on the choice of additional options, the PCC guarantees increased efficiency and flexibility while ensuring quality and process safety.
The design of the PCCs used in this project was tailored to the pharmaceutical manufacturer's requirements:
- A slightly conical shape of the knock-out vessel simplifies the product release of poorly flowing powders for a good and smooth discharge process.
- The special ViwateQ surface finish prevents product residues and adhesion in the knock-out vessel. This process was specially developed for the pharmaceutical and food industry and is a milestone in surface treatment. It also provides ideal conditions for cleaning.
- To prevent bridging, the ProClean Conveyor is equipped with an ejector valve and a pneumatic vibrating motor.
- One supports the scale for weight loss downstream. This allows for a very smooth and detailed continuous weighing and dosing with high production output.
Process Step 3
In the final step, the five weight loss scales feed the continuous mixer.
Conclusion
Looking at the overall logistics of powder processing in continuous pharmaceutical production, we see a number of new challenges. In particular, transporting raw materials in sufficient volumes and of perfect quality at the right time to ensure a stable, continuous process is a complex task for plant operators.
For continuous processes, especially for bulk raw material transport, Plant Partner is your ideal partner in this industry, offering a suitable solution for every application.
More Information
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