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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

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SERIALIZATION PRODUCTS & SERVICES

Single-lane Blistering, Cartoning, And Serialization Machine: BEC 300 Single-lane Blistering, Cartoning, And Serialization Machine: BEC 300

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.

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.

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LIFE SCIENCE WEBINARS

  • 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.

  • 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.

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