Troubleshooting

Paperless operations improve efficiency and increase assurance of product quality.

Experts discuss crucial aspects of measuring the stability of biologics, which exhibit greater variability in stability testing than do small-molecule drugs.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.

Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.

Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

Companies manufacturing cytotoxic drugs must ensure that staff are given the highest possible levels of protection.

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

Several chromatographic resins are available for downstream purification.

Several chromatographic resins are available for downstream purification.

Tooling can be damaged by poor handling or problems in process design or material choice.

Tooling can be damaged by poor handling or problems in process design or material choice.

Careful design of a single-use assembly by both the supplier and end user together can mitigate risks and create fitness for the intended use.

Risks associated with single-use technologies, such as product loss and sterility assurance, are magnified in the filling operation because of its closeness to the product in its final form. A thorough evaluation of the assembly design process, manufacture, and use can assist in identifying and mitigating these risks.

The final article of this series will look at the last two steps of the PharmaCare seven-step process?Lubricate and Store.

Solving the problem of tablet spots or specks involves prevention and thorough investigation.

A good cleaning regime goes hand in hand with a good polishing regime, which forms Step 5 of the process and is arguably the next most critical step. It is cleaning and polishing that deliver most noticeable benefit into production, reducing tablet press down time and helping to increase productivity.

Over the last three weeks, we have been looking at each step and the benefit of adopting the process. This week, we look at Step 4, Measure.

Over the last three weeks, we have been looking at each step and the benefit of adopting the process. This week, we look at Step 4, Measure.

Carrying on from our weekly column to help you eliminate a number of tablet manufacturing problems and tablet tooling failures with a simple seven-step tool-care process, we look at the third step, Repair.

As the second part of this series, we look at the importance of ?assessing? the punches and dies to check their condition and how this step may help avoid any problems that may occur during tablet manufacture.

The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

I Holland, in collaboration with the University of Nottingham and experts from the Laboratory of Biophysics and Surface Analysis, United Kingdom, recently completed a two-year tableting science anti-stick research (TSAR) project, which sought to understand why certain formulations stick to tablet tooling.

The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

The root cause of drug shortages is mismanagement of variation.