Pharmaceutical Technology
May 02, 2018
Product Spotlight
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Dolomite Microfluidics has developed the Drug Encapsulation System to provide scientists with a simple and scalable way of encapsulating drug samples.
May 02, 2018
Product Spotlight
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Eppendorf’s ViscoTip pipette tip from its Combitips advanced line can process liquids with viscosities from 200 to 14,000 mPa-s, including glycerol 99.5%, ointments, and creams.
May 02, 2018
Product Spotlight
42
5
Ross, Charles & Son's SysCon’s programmable logic controller (PLC) system features a control panel with a wireless connection that allows users to access the PLC system using tablets, laptops, and smartphones via Ethernet, WLAN, or Bluetooth.
May 02, 2018
Product Spotlight
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The MagMixer MBE Series from SPX Flow is suitable for low-viscosity blending, dissolving solids, and solid suspension in sterile applications.
May 02, 2018
Features
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Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.
May 02, 2018
Cover Story
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Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.
May 02, 2018
Regulatory Watch
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The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.
May 02, 2018
Features
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Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
May 02, 2018
Features
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Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
May 02, 2018
Features
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Integrated computerized systems for data collection improve data security and offer a solution for handling temporary data.
May 02, 2018
From the Editor
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A skilled workforce is needed to deliver on technology’s promising medical advances.
May 02, 2018
API Synthesis and Manufacturing
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Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.
May 02, 2018
Peer-Reviewed Research
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The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
May 02, 2018
Regulatory Watch
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FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
May 02, 2018
Outsourcing Outlook
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CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
May 02, 2018
Ask the Expert
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Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
May 02, 2018
Features
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Shipping biopharmaceuticals in single-use containers requires a thorough understanding of the distribution cycle and potential transportation risks.
May 02, 2018
Features
42
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The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
May 02, 2018
Statistical Solutions
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This article looks at a simple structured approach to assigning variance contributions and to assuring that the analytical procedure is fit for purpose.
May 02, 2018
Features
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Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
May 02, 2018
Issue PDF
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Click the title above to open the Pharmaceutical Technology May 2018 issue in an interactive PDF format.