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Pharmaceutical Technology-11-02-2015
Pharmaceutical Technology
Using Dynamic Thermal Imaging to Correct Sealing Problems
November 02, 2015
Troubleshooting
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Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.
CMOs Continue to Improve Overall Biomanufacturing Performance
November 02, 2015
Outsourcing Outlook
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Better process development is creating industry benchmarks for bioprocessing.
FDA Overhauls Inspection Operations
November 02, 2015
Regulatory Watch
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New program emphasizes quality, risk, and global collaboration.
Good Documentation Practice: Saving Data for the Long Term
November 02, 2015
Ask the Expert
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Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
Identifying Causes Of Delamination
November 02, 2015
Peer-Reviewed Research
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Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.
Piloting Track-and-Trace Implementation
November 02, 2015
Supply Chain
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Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
Advances in Heterocyclic Chemistry for API Synthesis
November 02, 2015
API Synthesis and Manufacturing
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Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C–H silylation reactions
EU’s New Telematics Strategy for the Regulation of Medicines
November 02, 2015
Regulatory Watch
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The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.
Exploring the Potential of Continuous Coating
November 02, 2015
Features
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Industry experts share insights on the advances in tablet coating technologies and the potential of continuous coating in solid-dosage manufacturing.
Demonstrating Therapeutic Equivalence for Generic Topical Products
November 02, 2015
Formulation
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The determination of topical bioequivalence requires a multi-faceted approach, tailored specifically to the generic-drug formulation.
Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?
November 02, 2015
Special Report
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The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
Single-Use Shipping Solutions
November 02, 2015
Product Spotlight
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Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids.
Tablet Press
November 02, 2015
Product Spotlight
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IMA Active’s new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.
High Shear Mixers
November 02, 2015
Product Spotlight
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Ross’ Batch High Shear Mixer features a four-blade rotor running within a close-tolerance stator at variable tip speeds up to 3000-4000 ft/min.
Packaging Inspection Machines
November 02, 2015
Product Spotlight
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Pharmaceutical inspection machines from Bosch Packaging Technology include the KHS 1, which uses laser headspace analysis (HSA), and the AIM 3, which uses high-voltage leak detection (HVLD), for container closure integrity testing.
Industry Suppliers Honored for Innovative Advances
November 02, 2015
From The Editor
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The CPhI Pharma Awards celebrate innovations in the pharma industry.
Advances in Heterocyclic Chemistry for API Synthesis
November 02, 2015
API Synthesis and Manufacturing
39
11
Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.
Better Days for Parenterals?
November 02, 2015
Cover Story
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Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.
Addressing Parenteral Manufacturing Challenges
November 02, 2015
Cover Story
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Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.
Pharmaceutical Technology, November 2015 Issue (PDF)
November 02, 2015
Issue PDF
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Click the title above to open the Pharmaceutical Technology November 2015 issue in an interactive PDF format.