White papers are sponsored content and is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.
In cleanrooms and other critical environments, it’s important to understand the role that proper wiping technique plays in reliable and consistent contamination control. When cleaning contamination you cannot see, technique is a sure way to know you’ve covered the surface area in question.
Industrial freeze-drying processes increasingly demand the use of wireless, battery-free, and accurate temperature sensors which allow a deeper understanding of the lyophilization process and monitor in real-time product behaviour. The new Sublime sensors aim to respond to this growing need with their wireless power transmission and communication, and multi-point measuring system consisting of...
Much like a chain is only as strong as its weakest link, a pharmaceutical cleanroom is only as sterile as its most unhygienic element. Even the smallest microorganism can spoil or degrade entire batches of pharmaceuticals and hygiene-sensitive products. That’s why it is essential that all equipment, tools, and personnel in a cleanroom are—in fact—clean.
This article explores the complexity of pharmaceutical engineering and offers a concise overview of crucial engineering practices essential for successful project design and execution. This piece offers a succinct overview of how these engineering principles intersect with the qualification process, a vital step in securing regulatory approval. We focus on the vital role that engineering plays...
The European Union's Medical Device Regulation (EU MDR), which came into effect in May 2021, has not only brought about significant changes to safety requirements but has also presented the medical device industry with a host of new challenges. Register to download this whitepaper to…
The demand for cell and ex-vivo gene therapies is steadily increasing, given the impressive efficacy of autologous chimeric antigen receptor T-cell (CAR-T) therapies against hematological malignancies. In recent years, the reality of curative treatment and commercial approval of several autologous CAR-T products triggered developers to plan for increased capacity and treating larger patient...
Traditional endotoxin tests are time-consuming and require significant hands-on time. Now with the use of microfluidics, liquid handling and hands-on time can be significantly reduced, alongside a reduction in LAL and sample volumes while maintaining compliance.
Temperature sensors used in critical applications are often placed into a thermal buffering device to ensure that normal and expected fluctuations in temperature-controlled environments do not cause false alarms. This is also called temperature damping. For example, when a refrigerator door is opened, the interior temperature will temporarily increase. However, the actual temperature of the...
As its title implies, Annex 1 is the European guidance document for good manufacturing practices of medicinal products. As such, it serves as the road map for sterile drug manufacturers to follow in order to arrive at the pathway to the highest level of sterility, assuring that their medicinal drug products deploy operational best practices, are certifiable, and regulatorily safe.
Technology has been changing the way we communicate for almost as long as we’ve been able to send a message from one person to another. From cave paintings to emails, we now communicate faster, clearer, and from greater distances. Documentation has experienced the same incredible advancements and that has significant impacts on industries that are dependent on it, such as the life sciences...
With any successful manufacturing endeavor, eventually, demand will exceed manufacturing capabilities. When this happens, scaling up from a laboratory or pilot plant is critical for meeting increased production demands. However, there are many changing variables that need to be considered when you are looking to scale up a process.
This application note shows how TOC analyzers and common sensors in the industry recover 11 different compounds most often used in water and product analysis.
Since human therapeutics have rapidly evolved from small molecules to include complex biological products such as monoclonal antibodies (mAbs), viral vectors, autologous and allogeneic cell therapies, mRNA therapeutics, drug manufacturers and contract development and manufacturing organizations (CDMO) are considering how to design and operate multiproduct facilities to maintain agility and...
Increasingly the Medical Device industry is challenged to increase the OEE (Overall Equipment Effectiveness) of their manufacturing process. The Ethylene Oxide sterilization lines for medical devices are no exceptions.
In some cases, the current process operating in ethylene oxide factories is still manual or partially automated. This means that there are operators on the shopfloor...
Data integrity is critical in the life sciences industry because it ensures that the end product meets all the required quality standards. It is a process of maintenance and assurance of accuracy and consistency of the data over its entire lifecycle. If the integrity of the data you collect and record is not maintained, there would be no way to ensure that you are producing high-quality and...
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.