Case Study: High Containment Products in the Pharmaceutical Industry
As an expert in bulk material handling, the company HECHT had the privilege of participating in the development of a production facility for a globally crucial medication.Thechallengewas to create a facility capable of producing large quantities of the medication in a short time while meeting the highest quality standards.In a brief timeframe, HECHT designed and manufactured a customized facility for our client, a leading global pharmaceutical manufacturer with a production site in Ireland. This facility was tailored to the specific requirements of the medication's production. The modular design ensures high flexibility and scalability while ensuring process security.
Process Description
To ensure compliance with the customer's strict requirements for pharmaceutical production, HECHT adhered to international Good Manufacturing Practice (GMP) guidelines and designed the facility accordingly. The facility is equipped with advanced technologyand automation systems to ensure high precision and speed in medication production.
The system essentially consists of a combined containment drum/bag emptying station and a pneumatic conveying system. Only one operator is needed to supply raw materials for further production steps and change packaging at the filling station.
The facility allows for the emptying of drums and bags in the following ways:
Drum Discharging: For emptying, the drums are lifted at the back and connected to the glovebox through a secondary liner with a double O-ring connection. An additional unrolling seal secures the drum at the connection opening.
Big Bag Discharging: When emptying bags, the supply is through a side opening (lock) into the glovebox. The bags are opened and emptied within the glovebox while the lock is closed. Multiple filters and a fan in and around the glovebox ensure a dust-free environment.
For optimal ergonomic work, the bags are lifted using a scissor lift and pulled onto a roller conveyor. Through the side opening (lock) and another conveyor inside the glovebox, the bags reach the emptying position. The filters with the fan also ensure a dust-free environment inside the glovebox.
A suction shoe with an agitator at the bottom exit of the glovebox transfers the product to the pneumatic conveying system PCC. For the cleaning of the entire system, a mobile cart was developed for the suction shoe, and the motor was designed to be detachable from the suction shoe.
Furthermore, the operation of the machine and cleaning should be as uncomplicated as possible.
After emptying, the products are transported efficiently and gently. A suitable method fulfilling all these requirements is pneumatic conveying. Particularly noteworthy are dense-phase conveying or plug conveying. Both methods are characterized by lower conveying speeds, ensuring gentle transport of granules/powder and a high fill level in the pipeline system, guaranteeing segregation-free conveying.
In pneumatic conveying, the entire system operates under vacuum, facilitating the processing of highly active substances. The vacuum generated in the system prevents dust leakage. A common application in the manufacturing process is transporting granules from a container to a tablet press. Pneumatic conveying allows placing the container directly next to the tablet press or in another room instead of mounting it on the press. Our ProClean Conveyor (PCC200), specially designed for this purpose, meets high GMP standards for pharmaceutical manufacturing processes.
A vacuum pump is used to convey the product into the separation container. To maintain the vacuum, the system must be closed to the outside during operation. The product-gas mixture enters the separation container through the product inlet valve. The fine dust particles are separated at the ring filter. After the conveying cycle, the filter is cleaned, and the product discharge is initiated, for example, into a reactor container. Instead of a vacuum, a flushing medium (compressed air or inert gas) is used to reverse the gas flow direction. The fine particles separated at the filter are cleaned, and the ring filter is ready for the next conveying cycle. The process steps of evacuation, conveying/filling, and emptying of the separation vessel continue until the desired quantity is reached. The system is fully equipped with WIP (Wash In Place) and CIP (Clean In Place) solutions, and the cleaning processes are verifiable.
Conclusion:
To meet the specific requirements of this intricate process, regular communication between HECHT and the end customer was of utmost priority. Through ongoing feedback in a collaborative atmosphere, the project grew into a success for both parties. The development of the production facility for this important medication was a significant milestone in combating severe diseases. HECHT is proud to have contributed to this project and is confident that the facility can efficiently and reliably enable the production of high-quality medications, making a crucial contribution to improving global health.
Considering the entire bulk material logistics in pharmaceutical manufacturing, many challenges need to be overcome. Especially the transport of raw materials in sufficient quantity and quality at the right time to ensure continuous process supply poses a complex challenge. For purely continuous processes, especially in the bulk material transport of powders, HECHT is also a proven partner for the industry, offering the right solution for every application.