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The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 2.
Measurement system development is a time-consuming task that process development teams often underestimate. The amount of information and data collected during development can be overwhelming. Measurement system analysis (MSA) helps to quiet the noise and allows the team to focus in on meaningful information, which gives everyone peace of mind. MSAs ensure data from the process, and are as accurate as can be with the chosen system/method adding limited variation.
A developmental team tasked with building four class 102 pilot tools must define:
• material/part shrink information (critical to quality and critical to function steel safe dimensions)
• gate design/fill characteristics (melt flow)
• cooling profile
• overall production tool designs
A developed measurement system’s data accuracy plays a considerable role in allowing a team to make correct decisions for each information point. Based on the critical need and accuracy of the information, team members should choose data from a challenged and qualified robust system. Too many shortfalls can occur from using a non-qualified measurement system, the two biggest being cost and time.
Read the full blog here: http://medicaldesign.com/blog/smart-metrology-next-step-speeding-development-cycles-part-2
Particles in parenteral drug products continue to be an important concern. At the April-2017 AAPS Workshop <strong>Challenges and Patient Impact of Particles in Biologics</strong>, Fran DeGrazio, VP of Scientific Affairs and Technical Services, spoke on the topic: <em>Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components.</em> <br />
When evaluating the vial system for your drug product, how do you know you’re making good decisions about protecting the drug product while also meeting regulatory expectations for data requirements as outlined in ICH Q9? To illustrate how complex it is to determine how much data is enough to make good, sound, decisions on your vial containment system, two 20mm container closure systems (CCS) were evaluated with the primary difference being the hardness of the rubber vial stopper. The designs were identical for each stopper, meaning the specifications, nominal dimensions, and other major features were the same.
<p><strong>Applying metrology–the science of measurement–to the art of medical device design.</strong></p><strong></strong><p><strong></strong><em>The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 1.</em></p>
More and more information is being stored in the cloud, and the number of personal cloud users is on the rise with no signs of slowing down. Social media sites such as Facebook in the U.S. and Sina Webo in China are sites where everyone meets and where data is being stored permanently. Today, we seldom exchange photos via email or carry USB sticks for storing documents. Instead, we trust the cloud as our preferred place to meet and exchange information.
West recognizes its responsibility to operate with integrity and to proactively identify potential misconduct. We hold ourselves accountable to the highest standards of quality, integrity and respect for our team members, our shareholders, our customers, and the patients we jointly serve.
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