Troubleshooting

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Designing loss-in-weight feeders for accurate and consistent refill is crucial to a continuous solid-dosage process.

Designing loss-in-weight feeders for accurate and consistent refill is crucial to a continuous solid-dosage process.

A process-specific preventative maintenance program improves productivity and reliability.

A process-specific preventative maintenance program improves productivity and reliability.

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Safe handling of HPAPIs requires determining exposure potential and selecting appropriate containment strategies.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

A program for calibration and routine testing of weighing instruments ensures accurate results.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

Effective design of the tablet core and the coating process can help prevent film coating problems.

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.

The revised USP Chapter Sterile Product Packaging-Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods.

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.

Dynamic powder testing and measurement of bulk powder properties can complement shear cell testing to identify the causes of poor hopper performance in solid-dosage drug manufacturing.

Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.

A rheometer and powder flow tester can measure how pharmaceutical materials, such as powders from a hopper, flow.

Multi-faceted powder characterization, including measurement of dynamic properties, can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.

Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile pharmaceutical manufacturing process, including vial filling; operators share best practices for cleaning.

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Paperless operations improve efficiency and increase assurance of product quality.