Away with rigid processes: raw material supply in continuous pharmaceutical production
Compared with the traditional, 'rigid' batch process that still dominates the pharmaceutical industry, continuous production (Continuous Manufacturing) of medicines offers advantages not only in production capacity, but is also a decisive factor for product quality and process development thanks to extensive, continuous process analysis data. Unlike the batch-oriented approach, continuous production can significantly reduce production costs, shorten production times and considerably increase overall efficiency.
A renowned international manufacturer of pharmaceutical products with several production sites in Germany reached an important milestone in continuous production with a new continuous manufacturing facility. On two production lines, a GMP-compliant raw material supply for the continuous mixing technology (CMT) had to be guaranteed, with closed, safe containment product transfer, and a continuous dosing function also had to be implemented.
Dust-free systems (designed up to OEB level 3), high plant availability and an automatic CIP (Cleaning in Place) function were the customer's main requirements. In line with the principles of sustainability and Industry 4.0, the aim was full automatic integration into the overall process, with a focus on the energy consumption of the systems used and on regional handling and production.
Low-dust big bag emptying
After goods receipt, the big bags containing various active pharmaceutical ingredients and excipients (APIs) are transported to the systems, which are split across two rooms with five big bag emptying stations each. An emptying station consists mainly of the following components:
The connection system is the core component for a safe and dust-free connection of the big bags. The product to be emptied falls by gravity into a suction shoe, which forms the interface to the next process step.
The support table takes the weight of the big bag and secures heavy loads.
A walking paddle serves as a discharge aid to loosen poorly flowing products.
The associated frame holds the connection system and the big bag support. A pneumatic tensioning device pulls the big bag spout taut. Depending on the application, operating height and installation dimensions, various additional options are available.
A runway beam with chain hoist and lifting gear is needed to lift the big bags safely and position them above the connection system for emptying.
A special feature of this project is the fivefold cantilever gantry, consisting of three complete gantry units with two cross-connections. This special design led to major savings in the production process and allowed simplified installation in the limited space. The outlet connection system (AASEF) ensures low-dust emptying using the two-handed lever technique.
The dedusting filter integrated in the system, with pneumatic cleaning, captures dust directly in the connection system and prevents it from spreading into the extraction system. An additional inline sieving machine provides protective screening and stops any foreign matter that must not enter the product or that exceeds a certain particle size.
A mobile transport trolley allows the connection system and the attached suction shoe to be moved quickly for wet cleaning in a separate wash room.
After goods receipt, the big bags containing various active pharmaceutical ingredients and excipients (APIs) are transported to the systems, which are split across two rooms with five big bag emptying stations each. An emptying station consists mainly of the following components:
The connection system is the core component for a safe and dust-free connection of the big bags. The product to be emptied falls by gravity into a suction shoe, which forms the interface to the next process step.
The support table takes the weight of the big bag and secures heavy loads.
A walking paddle serves as a discharge aid to loosen poorly flowing products.
The associated frame holds the connection system and the big bag support. A pneumatic tensioning device pulls the big bag spout taut. Depending on the application, operating height and installation dimensions, various additional options are available.
A runway beam with chain hoist and lifting gear is needed to lift the big bags safely and position them above the connection system for emptying.
A special feature of this project is the fivefold cantilever gantry, consisting of three complete gantry units with two cross-connections. This special design led to major savings in the production process and allowed simplified installation in the limited space. The outlet connection system (AASEF) ensures low-dust emptying using the two-handed lever technique.
The dedusting filter integrated in the system, with pneumatic cleaning, captures dust directly in the connection system and prevents it from spreading into the extraction system. An additional inline sieving machine provides protective screening and stops any foreign matter that must not enter the product or that exceeds a certain particle size.
A mobile transport trolley allows the connection system and the attached suction shoe to be moved quickly for wet cleaning in a separate wash room.
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Product-friendly transport
Transport to the next process step is a demanding application in bulk solids technology. Operator protection and the prevention of cross-contamination have top priority. In the customer project, after low-dust big bag emptying, the product is transferred to the pneumatic conveying system (PCC) in the adjacent rooms via a flow-optimised, specially designed pipework system.
The conveying system consists of a total of ten ProClean Conveyors (PCCs), designed for safe and product-friendly transport of powders and granules. Depending on the additional options chosen, the PCC increases efficiency and flexibility and safeguards process quality and safety.
The design of the PCCs was adapted to the specific requirements of the pharmaceutical manufacturer:
The slightly conical design of the separator makes it easier to discharge poorly flowing powders for a flawless emptying process.
The special ViwateQ surface finish prevents the product from sticking to the separator vessel. This process was developed specifically for the pharmaceutical and food industries, represents a new dimension in surface treatment and also creates ideal conditions for cleaning.
To prevent bridging, the ProClean Conveyor is fitted with a discharge valve with a pneumatic vibrator.
A weighing system integrated in the ProClean Conveyor supports the downstream loss-in-weight feeder. This achieves very gentle and highly accurate continuous weighing and dosing at high throughputs.
In the final process step, the five loss-in-weight feeders supply the continuous mixer.
Transport to the next process step is a demanding application in bulk solids technology. Operator protection and the prevention of cross-contamination have top priority. In the customer project, after low-dust big bag emptying, the product is transferred to the pneumatic conveying system (PCC) in the adjacent rooms via a flow-optimised, specially designed pipework system.
The conveying system consists of a total of ten ProClean Conveyors (PCCs), designed for safe and product-friendly transport of powders and granules. Depending on the additional options chosen, the PCC increases efficiency and flexibility and safeguards process quality and safety.
The design of the PCCs was adapted to the specific requirements of the pharmaceutical manufacturer:
The slightly conical design of the separator makes it easier to discharge poorly flowing powders for a flawless emptying process.
The special ViwateQ surface finish prevents the product from sticking to the separator vessel. This process was developed specifically for the pharmaceutical and food industries, represents a new dimension in surface treatment and also creates ideal conditions for cleaning.
To prevent bridging, the ProClean Conveyor is fitted with a discharge valve with a pneumatic vibrator.
A weighing system integrated in the ProClean Conveyor supports the downstream loss-in-weight feeder. This achieves very gentle and highly accurate continuous weighing and dosing at high throughputs.
In the final process step, the five loss-in-weight feeders supply the continuous mixer.