Precision, Performance & Packaging

How mechanical shock, pressure, and transport instability create intermittent syringe defects in fill-finish lines Syringe defects in pharmaceutical fill-finish lines rarely occur in a predictable way. A line can operate at nominal speed for hours before a syringe suddenly cracks, breaks, or becomes damaged during transport. When this happens, teams investigate machine settings, glass quality, […]

Assuring container closure integrity (CCI) for an injectable product presentation is a governing principle that must be systemically applied during design, development , manufacturing, distribution and use of a sterile product in order to secure product’s SISPQ (Safety, Identity, Strength, Potency, and Quality) at all times. Injectable drugs must be manufactured to be sterile, and […]

Sterile packaging of pharmaceutical products is not just a regulatory requirement; it is a life-saving discipline. From injectable biologics to implantable medical devices, packaging is often the final barrier that keeps a sterile product safe from contamination on its way to the patient. Choosing the correct packaging system matters as much as the drug formulation […]

Sterile glass vial breakage remains one of the most persistent challenges in pharmaceutical manufacturing. Every broken vial means wasted product, downtime, and higher costs, while also raising patient safety concerns. Breakage can stem from mechanical impact, thermal stress, or inherent material defects. The good news: with the right combination of equipment upgrades, material selection, handling […]

For injectable products, assuring the integrity of the container closure system (CCS) and container closure integrity is fundamental to safeguarding product quality and patient safety over the entire shelf life. Developing an inherently robust CCS is an iterative process—guided by an understanding of product stability, manufacturing methods, and anticipated distribution and storage conditions. Product protection […]

It’s usually the small changes that lead to big results and pharma giant Sanofi proved this with its pharma production line optimization project. The company’s use of SmartSkin technology for this project at their Waterford plant in Ireland resulted in a massive reduction in downtime and an improvement in yield. Here’s what Sanofi did. Production […]

Data analytics in the pharmaceutical industry is evolving from being a compliance and reporting tool to playing a strategic role in helping take informed decisions. When used correctly, data analysis can play a big role in taking operational decisions, preventing time overruns, reducing quality related issues and unlocking Overall Equipment Efficiency (OEE) in the pharma […]

In pharmaceutical fill-and-finish operations, maintaining high Overall Equipment Effectiveness (OEE) is essential not just for efficiency, but for ensuring product quality, regulatory compliance, and cost control. In this blog, we will explore how a data-driven approach to OEE investigation combines real-time data with scientific analysis to guide impactful line modifications and reduce downtime. Why fill-and-finish […]

Martin Van Trieste is an accomplished entrepreneur, board governance expert, executive coach and biopharmaceutical executive. Martin is the retired founder and President Emeritus of Civica Rx, and was previously Amgen’s Chief Quality Officer. He also serves on the boards for Redica Systems. In 2023, SmartSkin was honoured to welcome Martin Van Trieste as Chair of its Board of […]