Liyofilizatöre ALUS™ ile Yükleme & Boşaltma

In collaboration with SCHOTT and HEUFT, GEA has developed a vial traceability solution that will help the pharmaceutical industry to implement the EU drug anti-counterfeiting directive, safeguard the rights of trademark and patent holders and, ultimately, protect patients.

Providing distinctive marking and complete traceability, including process and product monitoring data throughout the entire freeze drying process, the system also offers continuous quality inspection, 100% line clearance and precise sampling. 

HEUFT’s innovative code verification system is fully compatible with GEA’s Automatic Loading and Unloading System (ALUS™), which facilitates complete vial handling traceability. Features and benefits of this novel, reliable and flexible innovation include 

• integrated data management
• containment options (oRABS, cRABS, isolator)
• an integrated code reader
• loading/unloading speeds of up to 400/800 packages/min, respectively
• retrofit options for existing lines.

Pharmaceutical freeze dryers are increasingly being equipped with automatic loading and unloading systems to improve productivity and better protect both the product and operator from contamination. Although the sophistication of automatic loading and unloading systems continues to develop, production irregularities pose certain challenges, such as vials with missing or incorrectly place stoppers, incorrect filling volumes or poorly sealed vials.

Such defects are often only detected during offline or post-quarantine inspections; and, although this procedure is accepted as safe, it does have limitations. First, systematic variations such as reproducible filling volumes can’t always be corrected during production and could lead to the loss of an entire batch. A missing stopper could lead to product contamination and operator safety issues if processing potent material.

To solve these issues, Baumer and GEA have been working on a solution that not only offers maximum product safety, but can also be retrofitted into existing lines, making 100% inspection between filling and packaging a real possibility.

Baumer was able to draw on its experience with vision sensor technology and light barriers, providing a simple image-based quality control solution that includes integrated position recognition. As such, out-of-specification vials can be detected and reliably rejected. Up to 32 different characteristics can be identified, all in real-time, and automatically adjusts to changes in vial size.

If a freeze dryer is loaded and unloaded on the same side, all the inspection criteria can be tested using a single unit. For a pass-through design, two inspection systems are required. Thus, 100% traceability and filling-to-packaging line inspection can be achieved. Additionally images of any rejected vials can be saved to facilitate troubleshooting. This system represents a simple, cost-effective performance monitoring system that further enhances the operational reliability of pharmaceutical freeze drying.

The ALUS™ Backpusher provides the following benefits: improved user access and cleanability, cost-effective containment (only the product zone needs to be LAF protected) and enhanced leak test compatibility. Furthermore, all moving parts are bellow protected and completely contained within the freeze dryer chamber, facilitating CIP/SIP procedures. In addition, the system is fully Annex 1 compliant, with no parts present above the vials during unloading, and suitable for flat front and isolator containment operations.

During freeze dryer loading, the ALUS™ Starwheel module serves to position, count and stop — if necessary — the vials received from the in-feed conveyor to a pusher conveyor. With processing speeds of up to 500 vials/min, the Starwheel is both time- and cost-efficient and comes in an easy to modify format for rapid product changeovers.

The ALUS™ cold shelf loading module from GEA offers an efficient way to load vials onto precooled freeze dryer shelves. Prepared vials are transported by the intermediate pusher to the final shelf position at a rate of up 400 vials/min. No additional change parts are required, there’s no extra cost involved and no added buffer time for shelf changing. In addition, the number of moving package rows is freely selectable using the existing HMI software.