Author Archives: Laura

  1. Winter is Here: When and How to Conduct Seasonal Temperature Mapping.

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    As winter settles in and temperatures drop, it’s the perfect time to plan your winter temperature mapping exercises for areas where pharmaceutical products are stored. As per MHRA guidance, seasonal temperature mapping is critical for ensuring compliance and maintaining the integrity of temperature-sensitive products.  

    Let’s look at what temperature mapping involves, why it’s important, and how to execute it effectively this winter.

    What is Temperature Mapping?


    In essence, temperature mapping is the process of qualifying a storage environment to thoroughly understand the temperature variations experienced across the area. This is typically done by deploying temperature data loggers in a grid like pattern throughout the facility.

    • Duration: Data is typically collected over 7 to 14 days to account for fluctuations during working hours, nights and weekends.
    • Documentation: A detailed protocol and floor plan are developed before the exercise. These include the project scope and the exact placement of loggers.
    • Outcome: After data collection, a comprehensive report is created to:
    • Highlight facility performance.
    • Identify temperature excursions or deviations.
    • Recommend probe placement for permanent monitoring systems (a regulatory requirement).

    Why is This Important?


    • Regulatory Compliance: Temperature mapping ensures adherence to regulatory requirements and guidance such as the MHRA, EU GDP, WHO.
    • Facility Performance Assurance: Confirms storage areas are performing as expected, avoiding risks of temperature abuse.
    • Product Safety: Protects temperature-sensitive products from degradation due to poor storage conditions.

    How Often Should You Perform Temperature Mapping?

    Seasonal Mapping

    To meet regulatory standards and address environmental variations, mapping must be performed during both seasonal extremes:

    • Winter Mapping: Typically conducted between late November and early February. If your mapping exercise is due, now is the time to act!
    • Summer Mapping :  Typically conducted between July and August

    Requalification Intervals

    The frequency of temperature mapping depends on a risk-based approach, but here are some general guidelines:

    • Mapping for ambient areas is commonly repeated every three years with a regular Risk Assessment process
    • The Risk Assessment process should highlight any significant changes to the facility that may have an impact on performance, and could justify a requalification sooner than the 3 year period

    How Can Biomap Help?


    At Biomap, we specialize in temperature compliance services tailored to your needs:

    • Full Mapping Services: With expert engineers managing the entire project.
    • DIY Options: Hire calibrated loggers to complete the exercise independently.
    • Consulting Services: Guidance on regulatory requirements and optimization of storage conditions.
    • Permanent Monitoring Systems: Design and implementation to ensure ongoing compliance.

    Get Ready for Your Winter Mapping Exercise.


    Don’t wait for the chill to pass—plan your winter temperature mapping now to ensure your facilities remain compliant and your products are safe.

    Contact Biomap today for a no-obligation consultation or to schedule a site survey.

     

     

     

     

     

     

  2. ECA Webinar: Temperature Sensitive Pharmaceuticals – Transport and Vehicle Qualification (Live Online Training)

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    On 10th of October 2024, join ECA Academy Live Webinar: Ensuring the Safe Transport of Temperature-Sensitive Pharmaceuticals. Co-hosted by Kane Edgeworth, Director at Biomap, and Peter Kralinger Founder of Carrymed. Hosted by ECA Academy.

    Are you responsible for the transport or handling of temperature-sensitive pharmaceuticals? Maintaining regulatory compliance and protecting product integrity during transportation is vital:

    Biomap invites you to a live, online training session, co-hosted by Kane Edgeworth (Director at Biomap) and Peter Kralinger (Founder of Carrymed), focusing on “Transport and Vehicle Qualification for Temperature-Sensitive Pharmaceuticals.” This webinar, hosted by ECA Academy, will provide an in-depth yet concise overview of regulatory expectations and best practices for the transport of products requiring special conditions:

    What You’ll Learn: Gain practical insights into the qualification processes for vehicles and transport systems designed specifically for temperature-sensitive pharmaceuticals. This training will help you ensure compliance and safeguard your cold chain logistics:

    • Regulatory requirements for transporting temperature-sensitive products
    • Step-by-step vehicle qualification processes
    • Best practices for maintaining product integrity during transit
    • Practical applications of qualification for cold chain transport

    Who Should Attend?: This session is ideal for professionals working in:

    • Quality Assurance
    • Validation
    • Engineering
    • Logistics
    • Cold Chain Management
    • Regulatory Compliance

    Click the link for more information on the Webinar: Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification

  3. Biomap announces the opening of a new office in Dubai, UAE

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    Biomap DWC-LLC is proud to announce the opening of its new office in Dubai, UAE.  This new location is part of the company’s continued expansion and commitment to serving clients in the Middle East region.

    The new office, located in the heart of Dubai will focus on building strong relationships with businesses and organizations across the pharmaceutical industry, while also collaborating with colleagues in other locations to deliver high-quality solutions that meet the unique needs of each client.

    “We are thrilled to open our new office in Dubai and be part of such a vibrant business community,” said Kane Edgeworth, Director at Biomap Ltd and Biomap DWC-LLC. “We have a deep understanding of the local market and are committed to delivering exceptional service to our clients in the region, replicating our quality standards and experience from one of the most highly regulated markets in the United Kingdom.  We have been operating throughout the Gulf for more than 15 yrs and having a local presence will only improve our service and what we can offer”

    Biomap’s new office in Dubai marks another significant milestone in the company’s growth strategy. With a focus on innovation and excellence, the company is committed to expanding its presence in key markets around the world.

    For more information about Biomap’s services or to contact the team at the new Dubai office, please visit www.biomap.co.uk or call +971 52 894 4971

  4. Biomap joins forces with Hanley Technology in Ireland

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    Biomap is delighted to announce a new partnership with Hanley Technology in Ireland.  Hanley have over 30 yrs experience in Pharmaceutical factory process technologies and are located in a territory that is home to most of the world’s largest Pharmaceutical Companies.  Hanley’s experience and expertise perfectly complement Biomap’s ambitions to expand its existing Irish client base with Qualification and Validation services to the Pharmaceutical sector.  

    More info on Hanley Technology – https://www.hanleytechnology.com/about-us/

  5. Job Vacancy: Sales Engineer – Pharma (Based in the UAE)

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    We urgently require a highly motivated Sales Engineer to join our young but quickly growing company. The position can be based anywhere in the United Arab Emirates.

    Benefits: Mobile phone, Laptop, Expenses (Vehicle TBA)

    Working coverage Gulf Countries.

    The Role

    The Sales Engineer will be responsible for developing new sales as well as completing product and service installations at client facilities. A unique opportunity to be involved with hands on product installations as well as technical sales of a select portfolio of products and services. The role offers excellent growth and personal development opportunities in a fast moving environment.

    Your role will be:

    • to consistently meet realistic sales targets
    • to consistently meet targets for weekly new client meetings and marketing responsibilities
    • open New Business opportunities through market research & prospecting as well as managing existing accounts to create and maintain a healthy revenue pipeline
    • demonstrate and present Biomap solutions to senior positions within varying sizes of organisation
    • carry out installations for thermal mapping services and wireless monitoring systems including validation work (on site validation to meet FDA 21CFR Part11)

    The Ideal applicant must:

    • be a technically minded individual with ability to easily build and maintain relationships with existing and new clients
    • have excellent verbal and written communication skills
    • have at least 3 years experience working in the Pharma/Biotech industry, preferably in the area of product storage and distribution compliance
    • have excellent organisation and disciplined time management skills
    • be self motivated and comfortable working from home office as well as spending time travelling throughout UK
    • be comfortable with weekly sales reporting and working with ACT! CRM

    To apply, send your resume to info@biomap.co.uk

  6. Biomap spoke at GDP Conference Barcelona

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    Kane spoke at the GDP Conference: GDP and the real world, held in Barcelona on the 5th-6th June.

    The conference informed about recent experiences made in the implementation of the EU-GDP Guidelines.
    Challenges and possible solutions were discussed and examples used to demonstrate how the requirements could be put into practice.

     

  7. Good Distribution Practice (GDP): Meeting the challenges – April 19th London

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    Biomap’s Director Kane Edgeworth will be attending the PQG Good Distribution Practice event on April 19th in London, where they will be releasing a document suite Kane contributed to.

    For more information on the event click here

    If you are also attending, let us know – we would love to be able to meet with you – info@biomap.co.uk

     

  8. Pharmafreight’s 7th Annual AGM – Dubai

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    Pharmafreight’s seventh AGM took place last month in Dubai, with Biomap presenting to delegates a case study on trailer mapping done in conjunction with Pharmafreight USA.

    Pharmafreight partners from 17 countries took part, with the event hosted by both Emirates Airlines on day one, and Aramex Healthcare on Day two.

    The event presented several other talks in topics such as passive packaging and GDP audits. The feedback from the event was very positive, and we look forward to being a part of next year’s AGM in Philadelphia.

  9. GMP meets GDP 2017

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    Biomap Director Kane Edgworth will be speaking at this year’s GMP meets GDP course 14th – 15th November in Berlin.

    During this course, well experienced speakers will share their expert knowledge about all relevant aspects regarding the current GMP and GDP requirements and current developments in storage, transportation and Cold Chain Management of medicinal products. You will learn how these requirements evolve and how they can be implemented efficiently.

    Buy your tickets here.

  10. GMP meets GDP 2016

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    8th & 9th NOVEMBER 2016 – Kane Edgeworth (Biomap Ltd) will join speakers Dr Afshin Hosseiny (Tabriz Consulting Ltd), Emil Schwan (Swedish Medical Products Agency) and Dr Andreas Konig (Aenova Holding).

    During the course experienced speakers will share their expert knowledge about relevant aspects regarding GMP and GDP requirements and current developments in storage, transportation and Cold Chain management of medicinal products.  Kane Edgeworth will present on Temperature Mapping (Warehouse, Cold Storage & Vehicle Studies) including protocol preparation, consideration of seasonal variations & impact tests as well as results and final reporting.

    Speakers:
    Dr Afshin Hosseiny
    – Tabriz Consulting Limited
    Ian Holloway– Swedish Medical Products Agency
    Kane Edgeworth– Biomap Ltd
    Dr Andreas Konig– Aenova Holding GmbH

    Further details:

    www.gmp-compliance.org 

    www.concept-heidelberg.de 

  11. We’ve Moved!

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    We have recently moved to a new facility.  Please note our new address:

    19 Oliver Business Park,

    Oliver Road,

    Park Royal,

    London

    NW10 7JB

  12. MENA Pharmaceutical Cold Chain 2014

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    3rd & 4th JUNE 2014 – Biomap to present temperature mapping case studies at the upcoming ‘MENA Pharmaceutical Cold Chain 2014’ event at the Raffles hotel in Dubai, United Arab Emirates.

    The ‘MENA Pharmaceutical Cold Chain 2014’ event is aimed at engaging local and regional stakeholders and to highlight the regions cold chain practices.  The event will feature case studies, presentations and interactive discussions on how to overcome the day to day challenges in handling temperature sensitive pharmaceutical products.

    The Middle East has been one of the most successful growth areas for Biomap in the last 2 years having carried out projects across the territory and are delighted to accept an invitation to speak at the event.  Kane Edgeworth (Managing Director, Biomap Ltd) will present case studies on the temperature mapping of warehouses, cold stores and vehicles which have the best low rate vehicle insurance just in case anything irregular happen.