Troubleshooting

Non-compliance issues show that users find dealing with computer systems challenging.

Training, calibration, and preventive maintenance help prevent over-and under-weight tablets. The author discusses causes of off-weight tablets and best practices for tableting.

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

The rapid uptake of single-use vessels for use in bioprocessing applications has made assuring integrity that much more crucial; helium integrity testing can be used to test integrity and prevent failures.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

The author describes how liquid chromatography-mass spectrometry works and explains some of its advantages and disadvantages, particularly compared to high-performance liquid chromatography.

Warehouse layout and personnel training are crucial to successfully implementing a warehouse management solution.

A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.

A screening method predicts delamination in primary packaging.

Crushing, fracturing, and bending tests quantify hardness.

Crushing, fracturing, and bending tests quantify hardness.

Loss-in-weight feeders provide high accuracy for batch or continuous processes.

Speakers discuss modularization, single-use systems, and process validation in a series of podcasts available on the Pharmaceutical Technology website.

A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training

Loss-in-weight feeders provide high accuracy for feeding powders.

Room-temperature sterilization using nitrogen dioxide gas benefits parenteral drugs.

A Q&A with Michael Lacey, plant manager at the National Institute for Bioprocessing Research and Training.

Adopting a seven-step process resolves tableting problems.

Magnetic separation equipment reduces ferrous metal contamination.

Clean-in-place systems should be optimized during design and commissioning and after validation.

As-found data is a crucial component of pipette calibration for laboratories that must comply with GMP regulations.

Consider critical process parameters and strategies to optimize the manufacturing process.

Consider the time and expertise needed to maintain regulatory compliance and perform stability testing.

Today's pharmaceutical companies are striving to reduce costs and maximize efficiencies, and must make decisions on the best way to deploy their limited resources.

Our company needs more stability storage. What issues should we consider when deciding whether to build our own biorepository facility or outsource our storage?

Identifying and classifying rouge can help to determine CAPA.

Flexible, scalable control systems use program batch sequencing.