Pharmaceutical Technology-06-02-2017

Pharmaceutical Technology

Paperless Recorder Shortens Sampling Intervals

June 02, 2017

Product Spotlight

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The SMARTDAC+ GX series panel-mount type paperless recorder from Yokogawa Electric Corporation comes with new functions, including sampling intervals as short as one millisecond and the control and monitoring of up to 20 loops.

Sterilizer Uses Pulsed Light Technology

June 02, 2017

Product Spotlight

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The Robotic Pulsed Light Sterilizer (RPLS1) from Steriline uses pulsed light technology for ready-to-use nest sterilization and can sterilize tubs of syringes, vials, and cartridges.

Decoding Serialization Regulations

June 02, 2017

Supply Chain

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The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.

EMA Faces Brexit Challenges

June 02, 2017

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The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

Efficient Manufacturing Critical for Accelerated Drug Development

June 02, 2017

Regulatory Watch

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Approval of breakthrough therapies requires expedited quality assessment.

Do You Listen to What Your Data are Telling You?

June 02, 2017

Statistical Solutions

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This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.

Ensure Quality in a Contract Test Laboratory

June 02, 2017

Ask the Expert

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Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Facility Design Issues for Single-Use Processes

June 02, 2017

Features

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Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.

Pharmaceutical Technology, June 2017 Issue (PDF)

June 02, 2017

Issue PDF

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Click the title above to open the Pharmaceutical Technology June 2017 issue in an interactive PDF format.