The Allegro™ single-use platform provides a comprehensive range of disposable process solutions from upstream, through downstream to formulation and filling.
We have developed a unique approach, keeping the same materials of construction to allow easy scale-up from lab scale to full cGMP commercial operation, with the capability to provide the same robustness, reliability and batch records that you require to produce your drugs.
We can serve our customers globally with strong technical support and a very robust and reliable supply chain with our global manufacturing platform meeting all the necessary quality requirements. We pride ourselves on the strong quality by design and ease-of-use attributes that we put into all our Allegro single-use systems, thus allowing our end users to meet consistently all the appropriate safety and regulatory requirements.
Pall Allegro 3D biocontainers have been specially designed for large scale applications where 3D systems need to be both reliable and flexible while providing extreme ease of use during their installation in the appropriate tote. They are made from high quality film that meets the critical performance requirements expected for biotechnology and pharmaceutical manufacturing.
Connectors and Disconnectors
With its intuitive operation and three simple steps – Click, Pull, Twist – the Kleenpak Presto connector gives even greater levels of sterility assurance. Made from Bisphenol-A free polyethersulfone, each device can be autoclaved or gamma–irradiated. With 100% inspection at point of manufacture, and individual serial numbers that allow device traceability, the Presto connector is available in sizes ¼ in. to ¾ in. with unique tamper resistant colored coded cap for each size.
Pall's collapsible plastic Allegro totes enable easy implementation of 50 L, 100 L, 200 L and 500 L single-use systems around each unit operation, while reducing manufacturing footprint. The Allegro plastic tote has been specifically engineered in order to provide maximum flexibility in the processing environment with stackable, maneuverable and collapsible features.
The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering design principles and criteria for robust mixer design to deliver the ultimate in mixing performance. The 50 L mixer is a scale down version of the larger mixers in the Allegro range (200 L, 500 L and 1000 L) with the additional feature of an advanced impeller design to facilitate low volume mixing down to 2 L.
PD2 powder handling bags from Pall have been developed to combine the virtues of effective containment and high product recovery with the cost savings and efficiency of single-use technologies. The PD2 film has been developed to allow the bags to be supplied in irradiated or non-irradiated formats, depending on the application requirements.
Pall Helium Integrity Test (HIT™) system used with Allegro™ 2D single-use systems (SUS) is a cutting-edge supplier integrity test for SUS implemented in critical processing steps of drug substance or drug product, to enhance patient safety. This test can detect down to 2 µm defects.
Kleenpak Presto Sterile Connector
With its intuitive operation and three simple steps – Click, Pull, Twist – the Kleenpak Presto connector gives even greater levels of sterility assurance. Made from Bisphenol-A free polyethersulfone, each device can be autoclaved or gamma–irradiated. With 100% inspection at point of manufacture, and individual serial numbers that allow device traceability, the Presto connector is available in sizes ¼ in. to ⅝ in. with unique tamper resistant colored coded cap for each size.
Single Use Systems
Expanding Applications for Single-Use Technologies
According to BioPlan Associates, the market for disposable technologies in biopharmaceutical manufacturing is expanding at a very healthy rate of 16-18%. In addition, Transparency Market Research estimates that currently only 25% of the market can be attributed to commercial cGMP manufacturing applications. With significant expected growth in this segment comes a great need for adaptable technologies.
The adoption of disposable bioprocessing equipment has already been widespread for small-scale applications at the development and clinical manufacturing stages. Now that the concerns about the reliability and robustness of single-use solutions have been alleviated and the extent of their benefits have been clearly demonstrated, many biotech and contract manufacturing organizations are actively moving toward the implementation of disposable technologies for commercial manufacturing, particularly in newer multi-product production facilities.
In 2015, BioPlan Associates reported that more than 90% of facilities use single-use/disposable technologies and, when planning their manufacturing strategies, companies now typically consider both disposable and stainless steel options before making equipment purchases. The same study also found that 69% of respondents attributed improvements in bio manufacturing performance to the adoption of disposable technologies.
Single-use systems are attractive because they eliminate the need for cleaning and cleaning validation, resulting in reduced capital expenditures and faster setup and turnaround times. They also eliminate the risk of cross-contamination and provide greater flexibility to meet changing market needs by facilitating system reconfiguration ease and, as such, are ideal for multi-product facilities that may need to be replicated in multiple locations. Furthermore, disposable technologies can enable Quality by Design approaches, the use of process analytical technology, and continuous processing—all of which are encouraged by the US Food and Drug Administation.