pharm-serialization-995x60 pharm-serialization-995x60

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.

More From Serialization Featured Articles

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.

More Serialization White Papers & Case Studies

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.

More Serialization Products & Services

LIFE SCIENCE WEBINARS

  • 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.

  • Integrating Safety And Immunogenicity Assessments Into The Biopharma Preclinical Development Process

    Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established.

  • The Implications Of Inaccurate Forecasting In Biologic Drug Substance Manufacturing And Strategies To Mitigate Risks
    The Implications Of Inaccurate Forecasting In Biologic Drug Substance Manufacturing And Strategies To Mitigate Risks

    The biopharmaceutical market is undergoing tremendous transformation. Speed to develop and manufacture product has become a critical driver with increased competition and the pressure to be first to market. New process technologies, advances in cell line development and more targeted and complex therapeutic classes have created a challenging biopharmaceutical manufacturing environment with new capacity requirements.

  • 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.
     

More From Life Science Webinars