Loading and Unloading for Pharma Freeze Dryers
ALUS® Automatic Loading and Unloading Systems for Lyophilizers
When loading a freeze dryer, human intervention increases the risk of operator/product contamination. The ALUS® Automatic Loading and Unloading Systems minimizes this risk and, at the same time, reduces processing times, improves productivity and, by using state-of-the-art monitoring systems, decreases operational costs.
When loading a freeze dryer, human intervention increases the risk of operator/product contamination. The ALUS® Automatic Loading and Unloading Systems minimizes this risk and, at the same time, reduces processing times, improves productivity and, by using state-of-the-art monitoring systems, decreases operational costs.
Freeze Drying Loading/Unloading
As a pioneer in the field of freeze-drying innovation, GEA has been designing, updating and improving the ALUS® system for more than 30 years. In fact, we were the first manufacturer to develop this technology and create permanently installed units (conveyor-pusher systems). Other advances include introducing flexible, automatic guided vehicle (AGV)-led transfer cart systems and integrating a loading system inside an isolator. Our wealth of experience has resulted in a validated base of more than 220 production-scale ALUS® systems being installed worldwide, seven patents and an ongoing program of research and development to optimize both handling and maintenance.
ALUS® is designed to provide maximum flexibility in terms of containment, layout and product flow. This can include loading and unloading from either one side or two (pass through design).
This system is extremely flexible; for example, multipurpose lines for a broad range of products and formats are available. Loading can be done with a fixed push-pull system using an isolator or RABS systems, and unloading can be done with a Transfer Cart in oRABS-based facilities.
Furthermore, ATEX-compliant versions and systems designed to handle potent products or those using organic solvents are also available. In addition, the ALUS® can accommodate a wide variety of third-party filler and capper options, both upstream and downstream.
Benefiting from a compact and adaptable design significantly reduces the footprint of the plant, keeping building costs to a minimum and making integration in retrofit applications much easier.
The ALUS® portfolio for toxic (bottom) and non-toxic (top) products
Any decision to use ALUS® should be made based on your specific containment requirements, as well as layout, throughput speed and product-related details. If it is necessary to use ALUS® in conjunction with open (oRABS), closed RABS (cRABS) systems or isolators, then a fixed conveyer-pusher arrangement should be deployed.
Our push-pull (PP) system offers excellent ergonomics and considerable energy savings. It also reduces isolator and/or cleanroom expenditure. The baseplate depth of 600 mm ensures easy, direct window access to the areas behind the pusher. Further benefits include
| Stationary Push-Pull System | Transfer Cart System | |||||
| Automation | Manual | Semi-automatic | Fully automatic | Manual | Semi-automatic | Fully automatic |
| Handling | Frames | Frames | Trays | Frames | Frames | Trays |
| Trays | Trays | Vials | Trays | Trays | Vials | |
| Vials | Carpules | Vials | Carpules | |||
| open RABS | X | X | X | X | X | X |
| closed RABS | X | X | ||||
| Isolator | X | |||||
The ALUS® Transfer Cart system takes the whole loading and unloading process further by offering a flexible layout, more compact design and a wireless control system. Easy docking under laminar flow or oRABS and the ability to expand the system by adding additional freeze dryers when production demands increase are additional benefits.
Multiple freeze dryers can be loaded and unloaded using a single ALUS® Transfer Cart system (with up to four carts), depending on the application. So, as your system grows, additional production requirements can easily be accommodated. The ALUS® Transfer Cart offers
For applications that require “track-changing” flexibility, GEA offers the ALUS® Transverse Cart. Like the Transfer Cart, this option can run on inductive power lines, is retrofit compatible and flexible. Multipurpose lines are possible, as is loading and unloading in opposite directions with up to four carts.
System requirements include continuous and constant power transmission for all movements and LAF protection, an uninterruptable power supply and the highest possible product protection.
Depending on the application and layout, the push-pull (PP) system can be run in parallel with the transfer cart(s).
The mobile transfer cart distinguishes itself by its flexibility when charging several freeze dryers. Formatting and loading can run in parallel, thus optimizing the process.
Available Options for ALUS®
To further enhance the productivity of GEA’s Automatic Loading and Unloading Systems (ALUS®), a range of cost-effective modular options is available to customize your freeze-drying system. Each module and/or system component meets strict safety and regulatory requirements, and has been designed to ensure optimal product quality and high throughput rates.
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.
The LYOVAC™ Freeze Dryer is the ultimate cGMP-compliant pharmaceutical lyophilizer. Industrial scale production Freeze Dryers built to customer specifications - production sizes from 8m² to 55m² of shelf space and more than 1000kg condenser capacity to ensure high drying rates even on the largest machines.
Extending its range of LYOVAC™ Freeze Dryers, GEA now offers both integrated and standalone equipment for the production of small-scale batches and formulation or process development.
SMART LYO™ 冷冻干燥机有助于降低冷冻干燥成本，同时还能维护设备质量与性能、简化设备检验与记录并缩短交付时间。