The COVID-19 crisis has put unprecedented stress on healthcare product manufacturers for personal protective equipment (PPE), ventilators, vaccines, and targeted treatments. Regrettably, this has also created the perfect opportunity for criminals looking to profit from the pandemic. The frontline of defence in this battle is adding a digital layer of product protection.
Plant managers are regularly challenged to increase throughput on production lines. Improvements to existing infrastructure or processes is often the best option, but this requires knowing which changes to make. This is the aim of overall equipment effectiveness (OEE): a best-practices metric that indicates how well a manufacturing operation is utilized compared to its full potential. The OEE method measures line productivity based on three key performance indicators: 100% availability (no...
Manufacturers need to make sure that marking is correct and readable to ensure compliance with regulations, transparency for customers and to minimize product rework, scrap and recalls. We talk to David Habib, Markem-Imaje’s North America Solution Architect for Packaging Integrity for an expert’s view.
Do you wish the data across your pharma serialization lines was more accessible?
As someone who has worked in enterprise software for a long time, the “disconnected” nature of packaging line data is pretty incredible. Using Systech as an example, we may see network connectivity from enterprise systems to Level 3 Guardian, but rarely visibility to Level 2 Advisor and Level 1 Sentri.
Essentially, each line is its own island. We need to change that!
Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down, but is a growing threat.
Liquid Gold. That's how Interpol has described organized crime's view of vaccine demand. The more in demand a product is, the more it will be counterfeited. We can count on an absolute tidal wave of COVID vaccine and treatment counterfeiting to flood the markets now that the vaccine is available.
Crowdsourcing your counterfeit detection gives you an army of real-time field inspectors. The underlying tech is also your key to more connected customers.
Updated Sept 24 2020.
As of September 24, 2020 Class I medical devices needed to meet the FDA’s Unique Device Identification Final Rule. However, that date was postponed by the FDA in July with the publication of a new Policy Guideline document. That means the FDA will not begin enforcing the UDA Final Rule on these devices until September 24, 2022. By this new date,
Serialization was introduced by governments as a mechanism to protect the pharmaceutical supply chain over 10 years ago. Major serialization mandates in the US, EU and other regions are now live. Now is a good time to reflect back on this massive undertaking and review some “lessons learned”. We say this because serialization isn’t “over” in pharma.
Crime has no moral code. If you have a high-demand product, people will likely counterfeit it. Itcomes as no surprise that during this time of pandemic, counterfeiters are targeting everythingfrom hand sanitizer to test kits. (In 2020 I blogged about counterfeit COVID test kits and counterfeit COVID vaccines.)