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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 3.
Equipment standardization is a key element in cost savings for any company and covers a broad spectrum of equipment for manufacturing, but for metrology equipment it is vital. As discussed in an earlier blog, metrology loops and the data produced are becoming the long-lead process in tool acceptance and validation activities. Trusting the data and how or where it comes from is just as important. Standardizing metrology equipment is one way of establishing that circle of trust for the project team. Over time, a team will become more and more comfortable with the data sets they receive, and in a data-driven organization, this can be beneficial.
When companies strategically source and purchase equipment with the mindset of standardization, they win. When decisions are based on price, lead time, or immediate needs, the long-term effects can be detrimental to a company’s long-term goals. It may even negatively affect short-term project goals. Consider cost and timing for the following requirements that coincide with a non-standardized equipment purchase:
• Training, including learning curve (muscle memory, keyboard shortcuts)
• Programming in different software packages (job setup, no standardized file)
• Lack of plug-and-play option commonality (rotary indexer, laser scanner)
• New maintenance requirements and additional spare parts
• New work instruction creation
• Data collection system/file sharing handshake
• Validation protocol creation and execution
<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>
Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent <a href="http://www.nature.com/clpt/journal/v93/n2/full/clpt2012220a.html"><span style="color: #0000ff; text-decoration: underline;">paper</span></a>, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur. In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
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.
West is pleased to share a Q&A with Mark McElfresh, Vice President of Operations and Supply Chain at West contract manufacturing, that recently appeared in <em>Manufacturing Leadership Journal.</em><strong> </strong><strong><br></strong>
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