Filling Technologies Solutions
Pall recognizes that formulation and filling is a critical part of any drug manufacturing process and demands the highest levels of quality and reliability. Pall has a range of filling technologies and services that enables end user to carry out their operations with increased reliability and flexibility – while ensuring the product quality is designed into the manufacturing process.
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Enhanced drug safety by using Allegro™ single-use systems, tested to 2 µm at Pall with the Helium Integrity Test (HIT™) system.
Filling Technologies Applications
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Filling Needles
This versatile needle is easily integrated into new or existing single-use filling lines, where the fluid path is either autoclaved or gamma irradiated. Complete single-use assemblies incorporating the needles simplify filling machine operation, reduce assembly time and needle installation risks.
Standards
Pall SoloHill Particle Validation Standards support the training and testing of human inspectors and are designed to challenge and validate both manual and automated visual inspection methods.
Test Instruments
The Palltronic Flowstar LGR test instrument enables point-of-use leak testing of single-use systems up to 200 L nominal volume and provides the ability to test the integrity of the filters within the single-use systems. This technology has an extremely small footprint, is easy to use, and is compliant with current regulatory standards. The instrument allows end users to test endless configurations of single-use systems and filters, with one device, without compromising the sterility of the system.
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.
Ultra-Clean Sterilizable Packaging
Newform bags are medical-grade, low-density-polyethylene (LDPE) bags, ideal for packaging and gamma irradiation of stoppers, caps and closures, vials and containers, API, medical powders, buffers, media, filters, medical devices, cleanroom garments, syringe components and more.
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Palltronic Flowstar LGR Test Instrument
Single-Use Filling Technology
Filling Solutions
Pall recognizes that formulation and filling is a critical part of any drug manufacturing process and demands the highest levels of quality and reliability. Pall has a range of technologies and services that enables end user to carry out their operations with increased reliability and flexibility – while ensuring the product quality is designed into the manufacturing process.
Using technology from the Allegro™ program and also Pall sterilizing grade filters, Pall’s automated solutions ensure that manual interventions are minimized and increased sterility assurance is achieved. With the Allegro range of filling technologies, a complete single-use flow path is possible that allows end users to create more flexible multiproduct manufacturing facilities.