ALUS® Automatic Loading and Unloading Systems for Lyophilizers

Available for cRABS, oRABS and isolators, GEA’s Check & Sort application is H₂O₂ resistant, easy to handle and provides vial traceability that’s supported by a 21 CFR Part 11-compliant SCADA system. Able to provide pictures of your vials as they pass the camera/sensor, the selection criteria can be customized to meet your needs, checking for vials with missing or incorrectly placed stoppers, erroneous fill volumes or poorly sealed vials.

Check & Sort can also be used with coded vials and offers a throughput speed of up to 400 vials/min. With minimized format parts, changeovers to accommodate different size vials are simple and efficient. The Check & Sort application will assess whether or not a semi-inserted rubber stopper is present and correctly positioned. It can also assess the fill height level (solid or liquid), determine whether a cake is present and selectively reject out-of-specification vials.

LYODATA^® provides unique marking, clear identification and the consistent traceability of pharmaceutical primary packaging, making drug counterfeiting practically impossible. The system also offers continuous quality inspection, 100% line clearance and precise sampling. By assigning a unique identifier, we give your vial a name!

Ensuring distinctive and unmistakable marking and the 100% traceability of pharmaceutical products in vials or containers by laser marking and code verification, LYODATA^® also includes process and product monitoring data from primary packaging production, grading and freeze drying, right up to the final finished product.

Based on multipoint NIR measurements, the LYOSENSE^® online moisture sensor from GEA comprehensively and non-destructively evaluates freeze dried product cakes in real-time. This easy-to-install and use measuring device is a non-invasive solution to moisture control, enabling the detection of residual moisture, glass particles, cake homogeneity and API concentration.

Fully GMP and 21 CFR Part 11 compliant, and supplied with IQ/OQ/PQ support, the LYOSENSE^® needs no consumables and provides the following benefits: whole cake inspection; fast processing times (up to 400 vials/min); a simple operator interface; and replaces Karl-Fischer titration.

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 bellows 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 containment (isolator/oRABs) operations.

Providing a clear and defined barrier between the product and user areas, the ALUS^® Bellowpusher offers improved cleanability, better user access and a cost-effective containment option (only the product zone needs to be LAF protected). All moving parts are bellows protected and, like the Backpusher, flat-front containment is also possible. 

During freeze dryer loading, the ALUS^® starwheel module serves to position, count and stop the vials received from the infeed 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.

With loading speeds of up to 600 vials/min, two-row loading provides a stable process for small vials (14 or 16 mm diameter). Offering two-row guiding (all guides are Teflon coated) and no parts above the vials during loading, the system comprises easy-to-handle format parts and is also isolator compatible. Users benefit from higher throughput rates, greater productivity and much less freeze dryer downtime, all while ensuring optimized performance with no loss of reliability.

Fully compatible with all types of containment (oRABS, cRABS, isolator), this module provides an efficient way of unloading single rows of vials at speeds of up to 400 vials/min, offering easy sample handling (track and trace) and optional vial traceability. Single row unloading is an absolute prerequisite for compatibility with LYODATA^® and LYOSENSE^® functionality.