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SERIALIZATION FEATURED ARTICLES

  • Are You Prepared For The EU’s Falsified Medicines Directive?

    Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.

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SERIALIZATION WHITE PAPERS & CASE STUDIES

  • Contract Packaging Organization Install Track & Trace System To Meet Serialization Requirements

    Millmount Healthcare, a world-leading Health Products Regulatory Authorized Organization, specialize in pharmaceutical and healthcare blister and bottle/tub contract packaging. Millmount pride themselves on attention to detail and strict punctuality to fit stringent production requirements. Millmount found themselves in need of user-friendly, compact TQS solution capable of combining precise weighing with reliable serialisation of packaged products. The OCS Traceable Quality System represents a unique solution that combines all the future global Track & Trace requirements in one single system, intuitive and very easy to operate.

  • Pharma Manufacturer Installs '4-In-1 System' For Serialization, Weighing And Sealing

    The medium-sized pharmaceuticals company Krewel Meuselbach GmbH manufactures top-quality, affordable pharmaceuticals at its Eitorf (North Rhine-Westphalia) and Gehren (Thuringia) sites in Germany, using state-of-the art technology.

  • Countdown To The 2017 DSCSA Deadline: Serialization Strategies For Compliance

    The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.

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SERIALIZATION PRODUCTS & SERVICES

Seidenader Serialization Solutions Seidenader Serialization Solutions

Seidenader Track&Trace solutions enable serialization at each aggregation level in pharmaceutical packaging. We offer stand-alone solutions as well as integration of components into third-party systems at each secondary packaging level. Using serialization with 1D/2D coding including human-readable text, our solution supports anti-counterfeiting initiatives and ensures product authentication. And we guarantee conformity with legal and country-specific regulations – today and tomorrow.

Ropack Adds High Speed Blistering, Cartoning And Serialization Capabilities Ropack Adds High Speed Blistering, Cartoning And Serialization Capabilities

The BEC 300, manufactured by Uhlmann, is the eighth and newest blister line at Ropack Pharma Solutions. The single-lane unit integrates blistering, cartoning and serialization. The highly efficient BEC 300, which produces cold formed (alu/alu) and Aclar® blisters at high speeds, will be serialization-ready by May 2017, well ahead of the Drug Supply Chain Security Act (DSCSA) mandate of November 2017.

Marking And Labeling For Complete Serialization; Traceability Marking And Labeling For Complete Serialization; Traceability

The station printer generates a label with an individual serial number for the pallet. The technical data is provided by the capture of all shipping cases. The hand scanner provides the readout of label data for all shipping case as well as the corresponding pallet. The user management displays via 'hand scanner hierarchy' on the station screen, corresponding with the serial number of all items

Pharmaceutical Serialization Registration And Labeling Station Pharmaceutical Serialization Registration And Labeling Station

The Advanced Bundle Station (ABS) uses a high resolution camera to read the 2D codes of every single carton aggregated into a bundle. Once these codes have been verified the external database will assign the bundle a unique serialization code. This code is then printed directly onto the bundle and verified. The bundle is then registered with all data for the cartons contained within a bundle.

Track & Trace Line Management Software For Pharmaceutical Packaging Track & Trace Line Management Software For Pharmaceutical Packaging

The Pilot Line Manager Software is an innovative software management system which controls all printing devices on pharmaceutical packaging stations via an Ethernet network. The software system collates all relevant data to create an electronic audit trail complaint to 21 CFR Part 11. A central user-interface handles and monitors all sensors, code readers, cameras and printers.

Pharmaceutical Serialization: Compact Control Unit For The Aggregation of Shipping Cases Pharmaceutical Serialization: Compact Control Unit For The Aggregation of Shipping Cases

The Shipping Case Station (SCS) is an all-in-one manual packaging station, which easily integrates with the inline shipping case packer (retrofit). Using the Pilot Line Manager (PLM) software, the system manages all installed devices to identify all corresponding items & bundles by their unique codes.

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LIFE SCIENCE WEBINARS

  • A New Way to Optimize Temperature Monitoring For The Pharmaceutical Supply Chain
    A New Way to Optimize Temperature Monitoring For The Pharmaceutical Supply Chain

    Watch the on-demand webinar and discover InTemp from Onset - an entirely new, fully-integrated, end-to-end temperature monitoring technology for Good Distribution Practices in the pharmaceutical supply chain.

  • How Cold Chain Planning Impacts Development And Commercialization Of Regenerative Therapies
    How Cold Chain Planning Impacts Development And Commercialization Of Regenerative Therapies

    New therapeutic products require new technologies, capabilities, resources and a thorough understanding of how temperature impacts preclinical and clinical studies and commercialization of regenerative medicines.

  • The Practical Application Of Home Healthcare

    Recruiting patients and retaining their participation in a clinical trial remain the biggest challenges faced by pharmaceutical companies when developing new medicines. For a patient, participation in a clinical trial can be stressful and burdensome, resulting in one in four patients dropping out of a clinical trial prior to completion. With sponsors facing tight-timelines, increased regulatory scrutiny and spiralling budgets the desire to address these challenges has never been more prominent.

  • Modeling Time-Dependent Processes More Accurately To Improve Quality And Control

    Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.

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