Challenges in the GMP Environment
The controlled inhibition of RNases in sterile and non-sterile single-use equipment poses a significant challenge in the GMP (Good Manufacturing Practice) environment. Even small amounts of RNases can severely impact RNA handling, particularly RNA sequencing, due to their enzymatic activity.
Conventional deactivation methods, such as the use of DEPC, autoclaving, or thermal deactivation, are not only cost-intensive and time-consuming but also carry the risk of damaging materials or leaving chemical residues.
The effectiveness of the UV inactivation method is limited, as the radiation acts exclusively in a unidirectional manner, making it impossible to effectively treat multiple components in a single step. Furthermore, the UV inactivation method, like the thermal method, generally cannot be applied to bioprocess containers.
Innovative Solution
3CON offers a novel, patent-pending, comprehensive solution in the form of non-thermal plasma that generates ionized air and specifically inhibits nucleases. This groundbreaking method effectively inactivates RNases by breaking molecular bonds, particularly disulfide bridges, and oxidizing sulfur-containing amino acids.
With this innovation, 3CON is the first provider on the international market to offer a method that guarantees certified RNase-free single-use assemblies, containers, and laboratory equipment.
Two Fundamental Systems
This makes it possible to preserve RNA integrity by storing samples in a DNase/RNase-free environment.
Discover 3CON’s innovative RNase Inactivation Systems:
3CON's top-efficient solutions for the production of 2D and 3D single-use bags/containers
Increasing Demand for Single-Use Solutions Requires Efficient Manufacturing Processes
The shift from stainless steel to single-use solutions is driving the demand for 2D and 3D bioprocess containers. Currently, a significant portion of such single-use containers is still manufactured manually – a time- and cost-intensive process that does not meet the increasing market demands. Additional challenges include flexibility for different container sizes, integration into existing production lines, and adherence to the highest quality standards.
The custom-tailored 3CON solutions revolutionize this process, offering a groundbreaking approach to scaling production: from semi-automated production concepts to fully automated solutions that ensure the highly efficient manufacturing of both small and large batches with exceptional quality.
3CON’s systems are modular in design, providing maximum flexibility across various production stages. Each module—such as the welding base, cutting device, double packaging unit, camera-based quality control, or integrity testing station—operates independently, enabling seamless adaptation to specific production requirements and volumes at any time. To fully address the challenges of the market in the field of sealing, 3CON offers comprehensive solutions that integrate both conventional welding technologies and 3CON's advanced laser welding process.
Unique, ultra-flexible laser welding system:
Only one system for a variety of different bag shapes and sizes.
3CON's innovative laser welding process sets new standards for welding clear plastics in the production of 2D and 3D single-use bags and bioreactors. This cleanroom-compatible method offers maximum flexibility in size and geometry, allowing bags ranging from very small (e.g., 1 mL) to oversized containers (e.g., 250 L) in custom shapes to be produced in the shortest time possible. Since no special tools are required for welding, lengthy and costly tool production, as well as time losses due to tool changes, are eliminated. Additional versatile applications: welding of temperature control channels, precision (sampling) bags starting from 1 mL, and flexible, custom bioreactor bags.
Thus, 3CON's laser welding system is the ultimate solution for small and medium volume bag production in highly variable designs, as well as for prototyping – from concept to welded product in less than an hour!
Highly Productive High-Speed Systems:
These advanced 3CON solutions stand out particularly due to highly optimized processes and improved Overall Equipment Effectiveness (OEE) through automation and process parallelization. Another outstanding feature is the extremely low cycle time of the systems:
Globally industry-leading in 3D BPC production – only 100 seconds per bag/BPC!
:: 3CON Contact persons for detailed inquiries:
3CON contact person for detailed inquiries:
Dr. Lorenzo De Benedictis, MA
3CON Business Unit Manager Pharma & Medical
E-Mail: pharma.medical@3con.com
:: Photo Credit: All photos 3CON Anlagenbau GmbH
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