Collected data highlights that each delay in biotech projects generates revenue losses. With a significantly reduced lead time, our Allegro Ready range of single-use systems has been developed to accelerate implementation and reduce costly delays within your process.
As standard designs they are manufactured using preferred components from our unique ACMS (Advanced Central Management System) data management system, enabling us to select from a vast pool of qualified and stocked components. In addition to the increased speed from the moment of order to delivery, our Allegro Ready systems are accompanied by a quality risk management data package that covers the entire lifecycle of the system.
Easy access to our Accelerator℠ Documentation Center also comes as standard, providing full qualification documentation to meet your project milestones and satisfy regulatory requirements.
- The Allegro systems and associated hardware are manufactured under a Quality Management System certified to ISO 9001
- The Allegro biocontainers are 100% leak tested during manufacture
- Allegro biocontainers are manufactured in a controlled environment ISO 7 in operations
- Biological reactivity in vivo for Class VI - 50 °C Plastics
- USP 87 (cytotoxicity)
- ISO 10993 (biological compatibility)
- USP 661 Physicochemical tests for plastics
- European Pharmacopoeia (Section 3.1.5)
- Japanese Pharmacopoeia (Section 61 Part 1)
- European directive 85/572/EEC for food contact plastic materials
The assembled systems undergo stringent qualification and validation as part of the manufacturing process. Additionally, all assembled systems are inspected for quality.
A summary of available configurations for the standard systems is shown in the product datasheet.Figure 1
Standard Allegro 500 mL biocontainer with Kleenpak® Presto sterile connector
- Each unit placed is double bagged and heat sealed
- Supplied in box quantities
- Gamma irradiated
- In order to reduce our carbon footprint, we strive to provide single-use systems manufactured regionally. However, to ensure security of supply you may receive product from multiple global sites.
The documentation supplied with these systems is as follows:
- System certificate
- Irradiation certificate
- Product storage applications across the entire manufacturing process
- Buffer and media storage
See product datasheet.
Disclaimer: By ordering the standard products the customer agrees to the specifications mentioned here. Any deviations on the specifications need to be requested before ordering and will be treated as customized and bespoke.