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 have 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 time of order to delivery, our Allegro Ready systems are accompanied by a quality risk management data package that covers the entire life cycle 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 Ready filter sets are available with different sterilizing grade filter media and filter sizes and a choice of different connection types and tube materials.
Allegro Ready filter sets can be used in wide range of applications, including:
- monoclonal antibodies (mAbs)
- cell, and gene therapies at any process step for liquid buffer/media, semi-product filtration or final product filtration
All standard filter sets are supplied gamma-irradiated and supported with a comprehensive documentation package.
Two sterilizing-grade filter medias are available in standard filter sets:Supor® EKV filters and Fluorodyne® II DFL filters for different applications.
Allegro Ready single-use filter sets are manufactured under a Quality Management System certified to ISO 9001 Quality management systems.
All Pall single-use systems are produced according to Quality by Design approach, including considering components validation, junction validation and application validation. All joints are 100% tested. The single-use systems are manufactured in a controlled environment (ISO 7 in Operations).
- Manufactured for use in conformance with current good manufacturing practices (cGMP)
- Filters included into the design are 100% integrity tested
- ISO 9000 Certified Quality System
- Meets United States Pharmacopeia (USP) <88> Biological Reactivity Test, In Vivo, for Class VI - 121 °C Plastics
- Test correlated to microbial retention
- Meets USP <85> Bacterial Endotoxins Test
- Meets USP <788> Particulate Matter in Injections
- The assembled systems undergo stringent qualification and validation as part of the manufacturing process. Additionally, all assembled systems are inspected for quality
Each unit placed is:
- double bagged and heat sealed
- supplied in box quantities, gamma irradiated
All Allegro Ready filter sets can be produced at multiple Pall manufacturing sites. System drawings with detailed information are available upon request - Please contact your local Pall representative.
Documentation supplied with these systems:
- system certificate
- irradiation certificate
A summary of available Allegro Ready filter set design configurations and detailed design and part number information is illustrated in the product datasheet.