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.
Efficient, safe and reliable performance
ALUS® provides maximum flexibility in terms of containment, layout and product flow, including loading and unloading from either one side or two (pass-through design). In addition, 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 and unloading can be done with a Transfer Cart in open RABS (oRABS)-based facilities.
ATEX-compliant versions and systems designed to handle potent products or those using organic solvents are also available. Plus, 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 retrofit integration much easier.
Key Features
- High performance: loading/unloading speeds of up to 500 and 700 vials per minute, respectively
- High operational safety: even for difficult vials with a diameter/height ratio of <3
- Can accommodate a wide range of different vial formats
- Excellent integration and interface co-ordination of ALUS® and the freeze dryer
- Patented design allows smooth transition of vials from ALUS® to a freeze dryer
- Improved safety: no moving parts above open vials
- Design complies to zone concept: no machine drives in vial processing area
- Frame-free operation
- High quality sterile design with excellent laminar flow properties
- Easy-to-use integrated software
- Parallel loading and unloading possible
Stationary Push-Pull System
The decision to use ALUS® should be based on specific containment requirements, as well as layout, throughput speed and product-related details. If ALUS® is to be used in conjunction with oRABS, closed RABS (cRABS) 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 direct window access to the areas behind the pusher. Further benefits include
- excellent cleanability (H2O2-resistant covering)
- no electronics above the baseplate
- no cracks or crevices
- stainless steel and FDA-compliant material.
ALUS® Robot Application
As pharmaceutical companies continue to implement the European Commission’s revised Annex 1 good manufacturing practice (GMP) guidelines (as per August 2023), GEA has already taken a significant step forward. The introduction of the ALUS Robot aligns with the industry’s commitment to increase product protection and eliminate direct human interventions.
Robots are a proven technology and have been used for many years in a variety of industries. The pharmaceutical manufacturing sector is also starting to recognize the benefits of robotic automation in terms of error-free product handling, increased operating speeds and the ability to process toxic products in a safe and reliable way.
- repeatability: consistent vial handling reduces variability
- precision: low contact processing minimizes scratches and defects while maintaining product integrity
- speed: enhanced throughput rates of to 1000 vials per minute can be achieved
- safety: eliminate the need for human intervention and reduce contamination risks
- agility: existing processes can be automated, allowing seamless integration into current operations.
ALUS® Transfer Cart System
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
- high levels of throughput, productivity and reliable performance
- flexible product flow and layout options
- multipurpose lines
- parallel loading/unloading (T-shape configuration)
- LAF protection
- inductive power transmission
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.
ALUS® Options
To further enhance the productivity of GEA’s ALUS®, a range of cost-effective modular options is available to customize your freeze-drying system. Each module and/or component meets strict safety and regulatory requirements and has been designed to ensure optimal product quality and high throughput rates.
LYOSENSE® Online Moisture Measurement
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.
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. All moving parts are bellows protected and completely contained within the freeze dryer chamber, facilitating CIP/SIP procedures.
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.
Bellowpusher
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.
Starwheel
During freeze dryer loading, the ALUS® starwheel module serves to position, count and stop the vials moving 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.
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.
Double row loading
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.
Single row unloading
Fully compatible with all types of containment (oRABS, cRABS, isolator), this module provides an efficient way to unload 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.
Continuous Monitoring and Full Traceability: LYODATA®
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!
Distinctive and unmistakable marking — and the 100% traceability of pharmaceutical products in vials or containers — is ensured 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.
Product Temperature Measurement
To ensure both material quality and process optimization during lyophilization, product temperature measurement is critical. To integrate this function, GEA offers the ALUS® Tempris Station. Using a PAT-compatible wireless sensor ensures uninterrupted continuous process verification (CPV), time savings and cost-efficiencies. It also facilitates product recovery and minimizes operational deviations.
During production, specific vials are directed to a secondary line or station. There, they are tagged with a sensor and automatically returned to their original position in the freeze dryer. The same sensors can be used in laboratory, pilot and commercial-scale freeze-dryers under cGMP guidelines to obtain comparable data for regulatory submissions.
Check &Sort application: Real-time checking during loading/unloading
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.
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Productos relacionados
LYOVAC® Pharma Freeze Dryer
GEA’s LYOVAC® industrial-scale freeze dryers are built to customer specifications and are available with production areas of 1–60 m² and condenser capacities of more than 1000 kg.
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SMART LYO™ Freeze Dryers help reduce the cost of freeze drying while maintaining quality and performance, making validation and documentation easier and reducing delivery times.
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