Whitepapers

- Why having a secondary biocide supplier is important - Information you should gather when selecting a secondary supplier.

Online tool predicts the optimal formulation of drugs New way to predict compressibility and compactibility

• Container closure integrity testing is vital for sterile injectable products. • The Headspace Gas Ingress method is a robust detection method of critical leaks. • This method is an upgrade to the blue dye test and can be scientifically validated.

Myths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.

Screening for developability and solubility issues Assessing pH and food effect when evaluating bioavailability Addressing solubility challenges

In partnership with Honeywell, Axendia research sheds light on opportunities and challenges experienced by leaders trying to modernize their life sciences production.

Eurofins’ whitepaper discusses insourcing & outsourcing solutions to solve challenges with meeting drug development timelines and budgets with restricted headcounts.

This whitepaper details how technological advancements by Syntegon and Corning allow for ultra high speed pharmaceutical fill/finish.

This note demonstrates the misconceptions of Maximum Force Compression. Proper formulation development and tablet design contribute to avoiding max compression force.

The integrity of cleanrooms must be preserved by an effective environmental control program. Selection of a disinfectant and sporicide should be based upon laboratory studies and trials involving in situ testing. The summarized case study demonstrates the efficacy of Vesta-Syde SQ 64 RTU and Spor-Klenz RTU in Grade C/D environments.

Learn how to avoid data integrity breaches and comply with increasingly strict regulatory requirements using informatics for electronic data capture and record-keeping.

Meeting detection challenges presented by nitrosamine impurities Determination of NDMA and nitrosamine impurities using triple-quadrupole LC/MS Determination of genotoxic impurities in ranitidine APIs and drug products

Understanding USP Water for Pharmaceutical Use On-line microbial instrumentation for real-time control of water quality Real-time TOC analysis of water purity

This application note describes key activities to accelerate biopharmaceutical tech transfer to support faster development and manufacturing programs.

Tablet press design innovation has traditionally centered on large-scale production equipment, however, there is increasing focus on the smaller-scale, mid-range models that must have the capability to support product development, scale-up, tech transfer, clinical batch manufacturing, small and medium batch production, and continuous manufacturing applications. This range of capabilities demands unique features and design flexibility.

Discover how platforms drive efficiency and get products to market faster. See why data connectivity improves quality and leads to better outcomes. Learn how to transform quality from an obligation to a business accelerator

Drug developers are increasingly using topical dosage forms for numerous reasons, but several factors must be considered to optimize the API's functionality including excipient selection. Trends and Formulation Strategies for Topical Drugs explores this topic and other areas of interest to developers.

-Stability testing for clinical trial materials -New services for oral solid dosage forms -Sourcing global clinical trials in the U.S. and Japan

Whether at the research and development stage, or manufacturing, the inVia Raman microscope offers simple and fast transmission Raman analysis

Explains the purpose, technology, and functionality of Track & Trace in the manufacturing and production process, and the reasons T&T applications have become so important.

-- Innovations in Tablet Press Technology -- Containment for Tableting: Best Practices -- Direct Tableting a Mixture of a Powder Matrix and API Loaded Pellets

-Recent workflow enhancements offer analytical efficiency and speed. -A new molecular spectroscopy method makes sensitive quantitation possible in minutes. -New UV-Vis technology allows simultaneous measurement of standards and unknown samples.

Learn how to use KPIs like Overall Equipment Effectiveness (OEE) to identify and close productivity gaps in batch manufacturing and improve product quality.

Tablet hardness is essential when formulating a solid dosage form. Certain combinations of commonly used excipients may lead to softer tablets. This study outlines how to avoid those pitfalls and learn which excipients will enhance compaction.