Automatic Loading and Unloading for Pharma Freeze Dryers ALUS™ Load & Unload of Lyophilizers

ALUS™ Automatic Load & Unload Systems minimize the risk of operator/product contamination while loading and unloading a freeze dryer, offering shorter times, improved productivity and using state-of-the-art monitoring systems, reduced operational costs.

Since the 1980s, GEA has designed, manufactured and improved the ALUS™ system and was one of the first manufacturers to develop this technology using permanently installed systems (conveyor-pusher systems), as well as flexible transfer cart systems.

ALUS™ - efficient, safe and reliable performance

ALUS™ is designed to give the user the maximum layout flexibility. This can include: loading and unloading from one side; loading and unloading from two sides (pass through design); loading with push-pull system under isolator or RABS systems; and unloading using Transfer Cart under RABS systems. ALUS can also accommodate a wide variety of filler and capper options. ATEX option available. The latest ALUS™ equipment is up to 45% more compact than its predecessors. This compact design significantly reduces the footprint to keep building costs to a minimum and allow much easier integration in retrofit applications. The new Transfer Cart ALUS™ is controlled by the latest wireless W-LAN panel. This provides precise control of the  system without any hard-wired connection. The wireless panel is much easier to handle when operating in a cleanroom and is easier to clean than hard wired equipment. Up to ten freeze dryers can be loaded and unloaded by a single ALUS™ transfer cart system (depending on the application) so as a system grows the additional production can easily be accommodated. This is a much more flexible system than fixed push-pull equipment and much more cost effective.

Stationary Push-Pull System

Lyophil_LYOVAC_Integrated_FAT

A decision to use ALUS™ would be made based on the containment requirements and product-related details. If it is necessary to have ALUS™ in conjunction with closed RABS (cRABS) or isolators, then a fixed conveyer-Pusher System has to be deployed. It is predestined not only for use with cRABS but also in the isolator. The mobile transfer cart distinguishes itself by its with flexibility when charging several freeze dryers. Formatting and loading can run in parallel thus optimizing the process.

Containment, Automation and Handling Options
Stationary Push-Pull SystemTransfer Cart System
AutomationManualSemi-automaticFully automaticManualSemi-automaticFully automatic
HandlingFramesFramesTraysFramesFramesTrays
TraysTraysVialsTraysTraysVials
VialsCarpulesVialsCarpules
open RABSXX  XXXX
closed RABSXX
IsolatorX
 

Key Features

  • High performance, with loading speed of up to 500 vials per minute and unloading speed of up to 700 vials per minute
  • High operational safety, even for difficult vials with a diameter – height ratio of <3
  • High flexibility for different vial formats
  • Excellent integration of ALUS™ and the freeze dryer through optimum interface coordination and integration
  • Patented design allows smooth transition of vials from ALUS™ to Freeze Dryer
  • Improved safety as no moving parts above open vials
  • Design complies to zone concept: no machine drives in vial processing area
  • Frameless operation
  • High quality sterile design with excellent laminar flow properties
  • No moving parts above open vials so as to increase safety and avoid product contamination
  • Easy-to-use integrated software

ALUS™ Transfer Cart System

Lyophil_ALUS_TC

The latest ALUS™ Tansfer Cart system from takes the whole process further by offering a flexible layout, more compact design, and advanced control system through a W-LAN Panel, easy docking under laminar flow, open RABS and the ability to expand the system by adding additional freeze dryers when production demands increase. ALUS™ minimizes the risk of contamination by eliminating human intervention during the loading and unloading of the freeze dryer. Automatic loading makes the whole process much quicker and allows for the use of sophisticated monitoring systems that help reduce operational costs.

ALUS™ Options

  • Vial traceability
  • Check&Sort
  • Single row unloading
  • Backpusher
  • Starwheel
  • Cold shelf loading

For further information please visit the options tab on this page

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 system component meets strict safety and regulatory requirements, and has been designed to guarantee optimal product quality and high throughput rates.

Vial traceability

Lyophil_ALUS_Vial Traceability

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.

Check&Sort application: Real-time loading/unloading monitoring during pharmaceutical freeze drying

Lyophil_ALUS_Turntable_w

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.

 

Patented single row unloading feature for automatic loading and unloading systems

Lyophil_ALUS_Singel Row Unloading
Fully compatible with all types of containment system (oRABS, cRABS, isolator), the ALUS™ single row unloading module from GEA facilitates vial sample handling (track and trace), overcomes previously experienced challenges with small vials and provides optional loading/unloading traceability. Using the principle of first in, first out, this novel, vacuum-powered technology offers an efficient way of unloading single rows of vials at speeds of up to 400 vials/min and provides a major step forward in lyophilization.

Backpusher

Lyophil_ALUS_Backpusher

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.

Starwheel

Lyophil_ALUS_Starwheel

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

Cold shelf loading

Lyophil_ALUS_Cold_Shelf_Loading

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.