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In Search of Consistency
. "It's not unusual to have four batch records attached to a product lot: one each for raw materials, solution prep, forming and packaging," Norz explains. "How do you manage all that information? With electronic batch records, one record contains it all,and that reduces paperwork and quarantine time...
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Medical Device Link .
New osteoporosis tests headed to market Consumers at risk for osteoporosis could gain some useful tools if recently released diagnostic products live up to their promise. For one, Osteometer BioTech (Copenhagen, Denmark) received FDA clearance to market its N-MID Osteocalcin enzyme-linked...
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The Future of Barrier Packaging
, CFF is poised to change the way that structures are formed. Existing metal forming technologies from other industries, if migrated to pharmaceutical machinery, offer the potential to achieve the geometries, speed and security demanded by the industry. Major changes can also be expected in the design...
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Tech Transfer: Don't Fumble the Hand Off
and operations personnel, is actually easier to put together at a small pharm/biotech company where professionals wear several hats. "Larger firms tend to have a lot of specialty silos," says Chatterjee of Pharma Tech. For the duration of the project, team members report to the project leader rather than...
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What is Advanced Aseptic Processing?
colony-forming units into the surrounding environment during each hour of work [1, 2]. Any technology that allows this level of interventional activity, and the potential for contamination associated with it, is too risky to be considered. Pharmaceutical Engineering | What is Advanced Aseptic...
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IFPAC Pre-Conference: Roadmap for PAT
, director, Office of New Drug Quality Assessment, FDA. ICH is forming a group to do this internationally. Simply, how a company defines the process can be a hurdle to PAT implementation. If the process is not defined in a more flexible way, unwanted FDA supplements might be necessary. In addition...
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Crystallization Imaging Offers Sneak Peak Inside Reactor
what's happening as crystals are forming - and we've shown that we can do this on a large scale," says Professor Kevin Roberts of the University's Institutes of Process R&D (iPRD) and Particle Science and Engineering (IPSE). "I believe we can help the manufacturing process become faster and more...
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Team Building: All For One and One For All
, are critical to effective problem-solving and decision-making. In fact, these skills are often more important than the technical skills for which team members were hired because the emphasis is now on the success of the Team. Set an Agenda, Focus on Process After forming the team, a clear agenda...
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Making the Difficult Look Easy: PAT at Talecris
in September 2004. We began by forming a multidisciplinary Core Team whose mission is to promote initiatives and review opportunities for PAT application. This team s direction is then executed by a PAT Implementation and Coordination Group, which was formed to prepare proposed PAT solutions...
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Aqueous Film Coating: Get It Right the First Time
for example, a clear coating or a controlled-release membrane. However, most coatings are formulated during the suspension process. Typically, a coating formula will consist, roughly, of 7 to 18% film-forming polymer, 0.5 to 2% plasticizer, and between 2.5 and 7% pigment or colorant. Table 1 summarizes...