Case Studies (copy 5)

Case Study: Moving away from ridig processes - Raw material handling in continuous pharmaceutical manuufacturing

Compared to the traditional, "rigid" batch process that still dominates the pharmaceutical industry, continuous manufacturing offers not only advantages in production efficiency but also plays a crucial role in product quality and process development through extensive and continuous process analytics. Unlike the batch-based approach, continuous production can significantly reduce manufacturing costs, shorten production times, and greatly enhance overall efficiency.

A prominent international pharmaceutical manufacturer with multiple production sites in Germany has achieved a significant milestone in the industry by implementing a new continuous manufacturing facility. In two production lines, the goal was to ensure GMP-compliant raw material handling for feeding the Continuous Mixing Technology (CMT) while maintaining a closed, secure containment product transfer, as well as implementing a continuous dosing function. The customer's primary requirements included dust-free systems (designed for up to OEB Level 3), high equipment availability and an automatic CIP (Cleaning in Place) function. Considering sustainability principles and Industry 4.0, the aim was to fully automate integration into the overall process with a focus on energy efficiency of the systems used and on regional processing and manufacturing.

Low-Dust Big-Bag Emptying

After the goods receipt, Big Bags containing various active pharmaceutical ingredients (APIs) and excipients are transported to the facilities which are split into two rooms with five Big-Bag emptying stations each. A typical emptying station consists of the following components:

  • Connection System: The core component for a safe and dust-free connection of Big Bags. The product to be emptied falls by gravity into an extraction shoe which forms the interface to the subsequent processing step.
  • Support Table: This supports the weight of the Big Bag and secures heavy loads.
  • Walk Paddle: An aid for discharging by loosening hard-flowing products.
  • Frame: Used to secure the connection system and the Big Bag support. A pneumatic tensioning device tightens the Big Bag outlet. Various options are available depending on the application area, operating height and installation requirements.
  • Track Carrier with Chain Hoist: Necessary to safely lift and position Big Bags over the connection system for emptying.

A unique feature of this project is the five-arm cantilever portal, consisting of three complete portal units with two cross braces. This special construction led to significant savings in the manufacturing process and simplified installation in the limited space available. The discharge connection system (AASEF) ensures low-dust emptying using a two-hand lever technique. The integrated dust extraction filter with pneumatic cleaning immediately removes dust within the connection system, preventing it from entering the extraction system. An additional inline sieve machine provides protective sieving, retaining any foreign substances that should not enter the product or exceed a certain particle size. A mobile transport cart allows quick transportation of the connection system and attached extraction shoe to a separate washing room for wet cleaning.

Gentle Product Conveyance

The transport to the downstream process step is a demanding application in bulk material technology, with operator protection and the prevention of cross-contamination as top priorities. In the customer project, following the low-dust Big Bag emptying the transfer process to the pneumatic conveying system (PCC) takes place through an aerodynamically optimized and specially designed piping system into the adjacent rooms. The conveying system consists of a total of ten ProClean Conveyors (PCC), designed for the safe and gentle transport of powders and granules. Depending on the choice of additional options, the PCC guarantees increased efficiency and flexibility, ensuring the quality and safety of the process.

The design of the PCCs was customized to the requirements of the pharmaceutical manufacturer:

  • Slightly Conical Design: The separator vessel's slightly conical shape facilitates the discharge of hard-flowing powders, ensuring a smooth emptying process.
  • ViwateQ Surface Finish: This special surface finish prevents product adhesion within the separator vessel. Developed specifically for the pharmaceutical and food industries, this method represents a new dimension in surface treatment and creates ideal cleaning conditions.
  • Anti-Bridging Device: The ProClean Conveyor is equipped with a discharge flap featuring a pneumatic vibrator to prevent bridging.
  • Integrated Weighing System: The integrated weighing system in the ProClean Conveyor supports the downstream differential dosing scale, allowing for very gentle and precise continuous weighing and dosing with high throughput.

In the final process step, the five differential dosing machines feed the continuous mixer.

Big Bag Discharginstations - supply of raw materials
Vacuum conveyor
Vacuum conveyor on differential dosing system
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