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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

  • 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.

  • Serialization, Track & Trace Installation For Solid Dose Contract Manufacturer

    Artesan Pharma Gmbh & Co. KG in Lüchow, Germany, demonstrates how an effective program of serialization, i.e. the traceability of medicines, can successfully be put into practice in today's pharmaceutical industry.

  • Aggregation: Integrated Solutions For Traceability In Pharma Products

    If you were to take a look at the criminal statistics of any given country, you would soon gather that counterfeits, imitations and fake products are on the rise among international criminal offences. Virtually all sectors have been affected; whether the electronics industry, the pharmaceutical industry, the automotive industry or the capital goods industry. It is an alarming development that has led governments and international organizations to draw up laws and measures against this growing crime.

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SERIALIZATION PRODUCTS & SERVICES

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.

Multi-Line Track & Trace Software For Pharmaceutical Packaging Multi-Line Track & Trace Software For Pharmaceutical Packaging

Pilot Site Manager (PSM) is capable of supporting multiple line solutions forming the basis for unique item level serialization and aggregation of serial numbers to packaging units. The software manages the writing, reading, printing of serial numbers and the provision of serial numbers within the packaging environment. Pharmaceutical manufacturers can be assured of their compliance with legal requirements and brand protection demands while laying the foundation to meet future serialization regulations. All PCE systems are standards-based and 21 CFR Part 11 compliant.

Pharmaceutical Serialization And Aggregation System – CPS 0400 Pharmaceutical Serialization And Aggregation System – CPS 0400

With the CPS 0400, the semi automatic aggregation solution, cartons can be easily and safely packed and aggregated into a case.

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LIFE SCIENCE WEBINARS

  • Assumption-Free Modeling Of Time-Dependent Processes

    Join this webinar to learn more about this unique approach and how you can benefit from it in different situations. Our Chief Scientific Officer will share the theory and background behind the solution and demonstrate how Unscrambler® X Batch Modeling from CAMO can improve the way we manage time-dependent processes and as an effect, get better quality control, detect events early and overall help improve quality of products and processes.
     

  • VaiNet: A Wireless Technology That Rises Above Crowded Frequencies

    In this webinar we discuss how advances in wireless technologies are changing the way environments are monitored, especially in regulated environments. We also introduce Vaisala’s VaiNet wireless technology.

  • How to Ensure Controlled Substance Compliance for Chemical and Pharma Companies
    How to Ensure Controlled Substance Compliance for Chemical and Pharma Companies

    In this webinar, the BIOVIA experts will discuss how CSCS ensures that teams can always take the proper care when handling controlled substances across their entire organization

  • Data Integrity - A Requirement for FDA Compliance, Quality and Beyond
    Data Integrity - A Requirement for FDA Compliance, Quality and Beyond

    Intended for leaders in science-based organizations, this webinar about how to achieve integrity of scientific and quality data in your organization will examine the relevance of data integrity and how it can be achieved from a process and technology perspective.

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