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FEATURED ARTICLES

  • Choosing A Vaccine Storage Temperature Logger: 5 Things To Look For
    Choosing A Vaccine Storage Temperature Logger: 5 Things To Look For

    In the life science and healthcare industries the proper storage of temperature-sensitive products – specifically vaccines – is a fundamental and growing concern with respect to public health. Case in point: The Centers for Disease Control and Prevention (CDC) has asserted that few immunization issues are more important than the appropriate storage and handling of vaccines. According to the CDC, approximately 13.5 percent of all refrigerated vaccines are subject to accidental freezing during storage.

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WHITE PAPERS & CASE STUDIES

  • Managing The Complexities Of Pharmaceutical And Life Science Logistics
    Managing The Complexities Of Pharmaceutical And Life Science Logistics

    Manufacturers and shippers of these products are under increasing pressure, as pharmaceutical and life science logistics becomes more complex and as the consideration towards better control of falsified medicines increases.

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

  • Successfully Manage The Unique Demands Of Cell Therapy Supply Chains
    Successfully Manage The Unique Demands Of Cell Therapy Supply Chains

    Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.

  • Complex Chain, Smart Security: How to Protect the Global Pharmaceutical Supply Chain
    Complex Chain, Smart Security: How to Protect the Global Pharmaceutical Supply Chain

    Your security strategy isn’t simple anymore, but that doesn’t mean it can’t be smart. As the industry has grown and changed, the pharmaceutical supply chain has become more global, introducing new vulnerabilities at each and every stage.

  • The Challenges to Safeguarding the Pharmaceutical Supply Chain
    The Challenges to Safeguarding the Pharmaceutical Supply Chain

    The loss of ingredients could trigger regulatory or legal liability, negative news coverage and a backlash from consumers criticizing your brand on social media. This is just one example of a potential risk your company’s global supply chain faces.

  • The Standards Myth: Why Your Temperature Controlled Packaging Is Failing And What To Do About It
    The Standards Myth: Why Your Temperature Controlled Packaging Is Failing And What To Do About It

    Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. While there is obviously a link between your shipping conditions and your thermal protection (packages), the challenge is that there is no clear, reliable industry standard temperature profile for the design of insulated packaging systems used for the distribution of products. This is because temperature profiles for packaging design should be rationalized based on not only your product characteristics, but your distribution logistics. This paper examines the lack of consistency in the current methodology for designing temperature profiles, why commonly used standards should not be used on their own, and identifies the needed parameters for consideration.

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PRODUCTS & SERVICES

Cold Chain Cloud Database: liberoMANAGER Cold Chain Cloud Database: liberoMANAGER

liberoMANAGER is ELPRO's cold chain database built as cloud solution that centrally collects, verifies, automatically processes, and archives LIBERO PDF reports from cold chain shipments or site monitoring applications and is accessible from any location via web browser. liberoMANAGER is offered as «Software as a Service» and is operated, maintained, and updated by ELPRO. The solution is operated on a highly reliable and high-security data center (certified ISO 27001).

KoolTemp® Room Temperature Solutions KoolTemp® Room Temperature Solutions

KoolTemp® Room Temperature Solutions are the industry’s most complete line of room temperature systems. Featuring multiple sizes and selective shipping time capacities designed for your room temperature shipment needs.

TempTrust™ 72 Hours Of Cold Chain Packaging TempTrust™ 72 Hours Of Cold Chain Packaging

Typical regulatory standards are adequate for setting a baseline package design. However, repeated studies show that without applying the knowledge of climatic conditions in the areas which products are shipped and stored, companies are missing a crucial element to designing qualification of packaging methods.

InTemp CX400 Series: Temperature-Controlled Storage Monitoring And Compliance InTemp CX400 Series: Temperature-Controlled Storage Monitoring And Compliance

The InTemp CX400 Series is a family of high-performance data loggers for monitoring temperatures in refrigerators, freezers, and other temperature-controlled environments.

Direct-To-Patient (DTP):  Secure Delivery Of Biological Samples Direct-To-Patient (DTP): Secure Delivery Of Biological Samples

Distributing clinical trial materials or collecting biological specimens can become complicated when a patient cannot easily access a hospital or clinic. To overcome this challenge, Marken developed Direct-to-Patient (DTP) services several years ago and is leading the industry with this service.

TempTrust™ Same Day Pharmaceutical Sample Cooler TempTrust™ Same Day Pharmaceutical Sample Cooler

Pharmaceutical samples are handled in a unique way. They are often stored at the sales rep’s home and then transported in a cooler stored in their trunk. In the heat of the summer, temperatures in a trunk can reach 45 C (120 F). This introduces unnecessary risk to the product. That’s why Infitrak has developed a portable storage solution specifically designed for pharmaceutical reps making same-day deliveries.

TempTrust™ 48 Hours Of Cold Chain Packaging TempTrust™ 48 Hours Of Cold Chain Packaging

Typical regulatory standards are adequate for setting a baseline package design. However, repeated studies show that without applying the knowledge of climatic conditions in the areas which products are shipped and stored, companies are missing a crucial element to designing qualification of packaging methods.

InTemp CX500 Series: Temperature-Sensitive Pharmaceutical Logistics Monitoring InTemp CX500 Series: Temperature-Sensitive Pharmaceutical Logistics Monitoring

Together, the InTemp CX500 data logger, InTemp mobile app, and InTempConnect cloud-based data warehousing service offer a seamless temperature-monitoring solution for Good Distribution Practices in the pharmaceutical supply chain.

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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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