Water is a key component in the pharmaceutical industry. It functions as an ingredient, a cleaning agent, a reagent, a solvent and a product, throughout the drug discovery process, from the initial identification of potential drug targets, all the way to the manufacture and quality control of the final product.
Cleaning and microbial contamination control are critical focus areas in pharmaceutical and medical device industries. Robust cleaning and disinfection programs are needed to meet the required cleanroom microbial grades, to prevent cross contamination and subsequent microbial contamination of products. This white paper reviews the latest cleaning and disinfection updates in the newly revised...
The growing expansion of gene therapy research in urban laboratory facilities presents a tremendous opportunity for high-throughput bioreactor applications. Recent advancements in bioreactor automation have improved lab efficiency and provided a critical experimental advantage in early discovery and process development work. These high throughput bioreactors can reduce risk while...
It can be confusing for business stakeholders and quality teams when it comes to the what and the why of transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA). CSA requires organizations to change their validation efforts from documenting extensive test suites to focusing on more critical thinking up front. Determining the areas of the business process and/or...
After six years in review, the final emergence of Annex 1 in August 2022 has either been a consolidation of accepted practice and wisdom or a rude awakening for many! However, it is universally accepted that it is decades' most significant single change to regulatory approach. As Annex 1 deals with products made in Europe, or products intended for Europe, it is likely to have a significant...
How to implement an effective methodology to manage data integrity risks based upon process understanding, knowledge of technologies, personnel, and procedures
Cleaning validation can be among the most painful and time-consuming aspects of GMP manufacturing for pharmaceutical developers, but "more complex" does not always mean "more compliant". In this new whitepaper, the Azzur Group's head of Cleaning Validation Services explains best practices for an optimized cleaning validation process and why thorough development, prior to validation, is so...
This article analyzes the hydrogen peroxide deactivation kinetics of representative bioburden in the pharmaceutical, healthcare and food industries, as well as the role of microbial and process variables, such as, type of microorganism (Geobacillus stearothermophilus or Bacillus atrophaeus), temperature, or particle distribution impact over the deactivation process. In addition, the effect of...
Investing in automated, paperless solutions is a logical step in driving laboratory productivity, reducing costs, and enhancing regulatory compliance. Any laboratory manager working with paper-based systems will have experienced the challenges they present, and as laboratories come under increasing pressure to do more with less, the case for digitalization grows. within the wider organization,...
Though tablet compression does not generate large volumes of fugitive dust, safe and efficient collection of whatever dust is created by this process is critical in achieving the widely held goal of “error-free performance.” A tablet press depends on a delicate balance of specified airflow and static pressure, climate control, precise material handling and compression force to run properly....