High-risk packaging applications, such as pharmaceutical and class III medical devices, are coming under increasing scrutiny. A package protects the product throughout the product life cycle, and package integrity is a significant pocket of risk that can be mitigated.
As companies around the world implement the necessary changes to become compliant, it will add an increased level of cost, risk, and especially complexity to today’s operations. Specifically, part of these mandates requires that production floor and warehouse equipment are able to exchange information with a customers’ business system throughout the drug’s packaging lifecycle.
The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.
Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls — resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.
Acquiring pharmaceutical processing equipment and successfully integrating it into operations is not as straightforward as it may seem.
An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. Forecasting and demand simulations are useful for anticipating when and where stock is likely to be needed to formulate a kit production and distribution strategy.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.
Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much moisture so it is uncommon to use a humidity sensor in a cold temperature situation (specifically closed chamber situations wherein the air is cycled over the cooler to remove the condensation. But initial cooling will result in 100% RH. But for the purposes of continuous monitoring we can go with the lower RH accompanying colder temperatures). Low temperature presumes low humidity.
A packaging technology known as blow/fill/seal (BFS) offers an automated aseptic method for creating single-dose packaging for vaccines, even those that are very sensitive to heat.
The latest in automated lubrication systems ensure optimum equipment performance — even in demanding pharmaceutical manufacturing environments — and reduce unscheduled maintenance.
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