Application Notes & Case Studies

  1. True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)

    One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.

  2. Biogen And Biovia: Answering Pharma Manufacturing’s Call

    Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly.

  3. Paediatric Drug Product Development Through To Commercialization

    Almac, in partnership with a US Biotech client and supported by Merz, a world leader in the design and fabrication of stickpack sachet machines has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture

  4. Late Stage Customization For Small Lots Of Blister Packaging

    Two years ago, Elaiapharm undertook the packaging of an important new solid dose product (Cipralex, an antidepressant) to be launched across a large number of international markets. The product itself is an ODT – orally dispersible tablet – formulation packed in child resistant cold form blisters.

  5. Autoclavable PP Blisters With Filled Disposable Syringes

    At the end of the packaging process, the packaged syringes should meet the requirements for sterile devices in the operating room. Therefore, the finished blisters are autoclaved at 121 °C (2 bar) for 15 minutes. Only minimal deformation of the blisters is tolerated, so that the syringes can be used in the operating room without problems after this thermal treatment.

  6. 2 Sachet Machines Connected To 1 Cartoner

    Volumetric feeding by means of a flowmeter, a method that has become established at Pharmatis, was also implemented in this project; the configuration was taken over by the Mediseal HMI. The feeding system is highly flexible and can be adapted to a wide range of products.

  7. Seamless Blister Packaging Production Line From Primary To Secondary Packaging

    The Challenge: The blister packaging needed a specific design requirements that would protect the delicate alu/alu blisters from the rest of the packaging, offer sufficient space for simple to use dosage instructions, and provide 2 different dosage sizes (one-month and three-month).

  8. 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.

  9. A Comparison Of Microbial Environmental Limits

    The new paradigm of microbial monitoring of aseptic processing environments, suggested in USP <1116>, continues to raise interest. Yet questions persist regarding its implementation and usefulness compared to existing regulatory limits.

  10. 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.