ISTA-Qualified Boxes for Temperature Sensitive Shipments
Line of pre-qualified shipping boxes includes a series of boxes to accommodate varying payload sizes, all qualified to International Safe Transit Association (ISTA) standards.
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Electrical Connectors Feature A Secure Latching System
The PowerMod®HP (high power) series connector family feature touch-safe female housings, cable strain relief and integral positive latches. The series is RoHS Compliant and rated up to 450 amps for appropriate applications at a 30º C temperature rise.
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Using Vision to Your Advantage
To meet ever-increasing industry regulations, pharmaceutical companies need to employ strict inspection and verification tools during product manufacturing and packaging processes. While simple sensors can be used for presence detection on the automated production line, to achieve accurate results in more sophisticated pharmaceutical applications—such as those requiring analysis of more than one product feature at a time—vision sensors can deliver a more comprehensive and cost-effective solution.
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Applying Operational Excellence in the Product Development Environment
Under the twin shadows of a struggling world economy and a growing mistrust of the global supply chain, is it possible to drive productivity and efficiency without sacrificing quality and safety? Over the last decade we have seen the industry embrace the basic tenets of Six Sigma1 and Lean Manufacturing, spurred in no small part by the 2004 FDA guidance which describes a Risk Based Approach to cGMPs and the ICH 8, 9 and 10 guidances
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FDA Tea Leaves - Nine Things To Expect In 2009
Next year will bring a tougher attitude toward drug, biologic and device makers by the U.S. Food and Drug Administration (FDA). Congressional critics, long frustrated by an agency seemingly more enamored with manufacturers than public safety, will push forward legislation encouraging a "tough love" stance that will last well into the next decade. The FDA will issue new regulations and update old ones to capture expectations that drug makers - and their suppliers - put a priority on public safety, product efficacy and policy compliance.
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Throughout my life I’ve been to countless sporting events – from local soccer matches my kids have been involved in up to major league events in almost every sport. If there is one thing I have learned over the years it’s that you can’t win an argument with a referee. Whether it’s an overzealous parent on the sideline, a student/athlete on a high school field or a professional athlete in a big city stadium – arguing with a referee or an umpire will get you no where. Yet people continue to do so - and frankly I don’t understand why. During a sporting event – the referee is the LAW out there on the playing field – and all of his or her decisions are final - so why bother fighting city hall? And yet many people continue to try – only to find themselves being thrown out of a game; or in the case of an overzealous parent – asked to leave the sideline.
A similar situation came to light recently when a major pharmaceutical manufacturer was warned by the FDA that they were in violation of the law by marketing over-the-counter pain relievers with unproven health claims.
The agency allows traditional pain relievers to be sold over-the-counter without review, as long as they include standard directions and labeling for consumers. But the FDA said the products from the company in question overstepped those regulations by claiming that the added ingredients in each medicine help fight specific diseases.
In general, the FDA discourages firms from packaging drugs with dietary supplements because it gives the impression both have been evaluated by the FDA, when in fact, the agency only regulates drugs.
What were they thinking? Going back to my sport analogy – the FDA is the referee and they make the rules – so what did this company hope to accomplish? In this case you can't fight city hall or the FDA and the repercussions are more severe than a simple red card.
FDA Tea Leaves - Nine Things To Expect In 2009 
