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Pat Lennon

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  • Joined 9 years ago
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  • Vijay - You will need more information to answer that question.

    1) Vaccine vials come in many different sizes. You would need to know what size vials are intended to be placed in the vaccine carrier and if there will be a mix of different vaccines, such as for a typical outreach session.

    2) The vaccine carriers have different storage capacities. You can find a list of PQS prequalified freeze-preventive carriers here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=18  There are currently five freeze-preventive carriers prequalified by WHO and their vaccine storage capacity ranges from 1.04 to 1.7 liters.

    Once the vial sizes and carrier capacity are known you could estimate the number of vials that the carrier could hold.

    In my experience the number of vials used for routine immunization outreach sessions is usually low so even the smallest vaccine carrier should work. If the carrier is being used in place of a cold box to...

    Vijay - You will need more information to answer that question.

    1) Vaccine vials come in many different sizes. You would need to know what size vials are intended to be placed in the vaccine carrier and if there will be a mix of different vaccines, such as for a typical outreach session.

    2) The vaccine carriers have different storage capacities. You can find a list of PQS prequalified freeze-preventive carriers here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=18  There are currently five freeze-preventive carriers prequalified by WHO and their vaccine storage capacity ranges from 1.04 to 1.7 liters.

    Once the vial sizes and carrier capacity are known you could estimate the number of vials that the carrier could hold.

    In my experience the number of vials used for routine immunization outreach sessions is usually low so even the smallest vaccine carrier should work. If the carrier is being used in place of a cold box to transport vaccines between facilities or for a campaign serving many people then more capacity and/or multiple carriers may be needed.

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  • I agree this is an important topic and appreciate the information provided by the community. Yogesh, thanks for sharing the performance details of the cold boxes as this information may not be easy for most people to find and it is useful for planning.

    In suport of Yogesh's points raised above regarding the Pfizer-Biontech vaccine, our colleagues at WHO recently released this training guidance available here on TechNet: Handling, storing and transporting Pfizer BioNTech COVID-19 Vaccine COMIRNATY® (Tozinameran) (technet-21.org)

    Thanks,

    Pat

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  • Dear Dr. Holla - I won't be able to answer all your detailed questions but I hope the information below is helpful.

    WHO PQS provides performance requirements for cold chain equipment that includes freezers - both water pack and vaccine freezers. Vaccine freezers were primarily used for storage of oral polio vaccine in case India has any guidelines on OPV storage and handling that could be helpful to you. One reason PQS differentiates between vaccine and water pack freezers is because there is concern that placing warm water packs next to vaccine would result in localized warming inside the freezer which could potentially reduce shelf life of the vaccine.

    The freezer performance specifications can be found here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/catdocumentation.aspx?id_cat=17

    A list of PQS prequalified freezers and refrigerators is here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=17

    S...

    Dear Dr. Holla - I won't be able to answer all your detailed questions but I hope the information below is helpful.

    WHO PQS provides performance requirements for cold chain equipment that includes freezers - both water pack and vaccine freezers. Vaccine freezers were primarily used for storage of oral polio vaccine in case India has any guidelines on OPV storage and handling that could be helpful to you. One reason PQS differentiates between vaccine and water pack freezers is because there is concern that placing warm water packs next to vaccine would result in localized warming inside the freezer which could potentially reduce shelf life of the vaccine.

    The freezer performance specifications can be found here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/catdocumentation.aspx?id_cat=17

    A list of PQS prequalified freezers and refrigerators is here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=17

    Some of your questions above are covered in the freezer equipment specifications.

    For the freezer temperature logger I would reccomend one with a temperature probe that goes inside the freezer and the data logging and display sits outside the freezer to make reading temperature and accessing data easier and to reduce door openings. 

    PQS has a list of prequalified temperature monitoring devices at the following link but I'm not aware of freezer specific devices: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=35

    Some of your questions about vaccine packing and handling time will be dependent on the thermal stability of the specific vaccine in question so are best answered by the vaccine developer. I'm not aware of a vaccine that is required to stay frozen durning an immunization session. Typically COVID vaccines are allowed to be thawed at 2-8C before use - but confirm with vaccine developer directly.

    Thanks,

    Pat

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  • Pat Lennon replied to a discussion, Cold chain for covid19

    Rafael - You raise important questions and I don't believe there are concrete answers to them yet. Here is some information that may be helpful.

    WHO R&D Blueprint for COVID-19: https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/

    The Bill and Melinda Gates Foundation is making significant investments in multiple vaccine candidates: https://thehill.com/changing-america/well-being/prevention-cures/491006-bill-gates-is-funding-factories-for-7-potential

    The Foundation understands that a vaccine will be needed in all countries to protect everyone from a highly contagious virus. Given the amount of international travel still occuring just vaccinating a few rich countries won't be effective at stopping a pandemic.

    The Foundation is also investing in research on treatment options until a vaccine is available: https://twitter.com/gatesfoundation/status/1246095455726886913?s=12

    You posted your question to the cold chain equipment forum. What we don't know yet...

    Rafael - You raise important questions and I don't believe there are concrete answers to them yet. Here is some information that may be helpful.

    WHO R&D Blueprint for COVID-19: https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/

    The Bill and Melinda Gates Foundation is making significant investments in multiple vaccine candidates: https://thehill.com/changing-america/well-being/prevention-cures/491006-bill-gates-is-funding-factories-for-7-potential

    The Foundation understands that a vaccine will be needed in all countries to protect everyone from a highly contagious virus. Given the amount of international travel still occuring just vaccinating a few rich countries won't be effective at stopping a pandemic.

    The Foundation is also investing in research on treatment options until a vaccine is available: https://twitter.com/gatesfoundation/status/1246095455726886913?s=12

    You posted your question to the cold chain equipment forum. What we don't know yet is how thermostable any new vaccines will be. Will the new vaccine(s) be able to be stored in 2-8C? Will they be freeze sensitive? Or will they have special requirements similar to the first Ebola vaccine? I believe we will need to track information on succesful candidate vaccines as they becomes available to see what the appropriate pandemic vaccine supply chain approach will be - and what new equipment, if any, is needed.

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  •   Dan Brigden reacted to this post about 4 years ago

    In January 2019, PATH and the Solar Electric Light Fund (SELF) partnered with the government of Senegal to evaluate a smart energy management device attached to certain solar vaccine refrigerators that would enable health workers to use electric devices in areas with limited or unreliable power. Called an energy harvest control (EHC), the device consists of a smart switch that takes excess power generated from solar panels already powering the refrigerators and safely allows the energy to be used for devices such as lights, fans, mobile phones, and some medical devices. The EHC configuration varies by solar direct drive (SDD) refrigerator manufacturer, but each device can access the excess energy, including through USB ports or 12 VDC sockets. The evaluation is taking place in four health posts in the Meckhe and Tivaouane districts of Senegal.

    To date, three EHC devices have been prequalified by the World Health Organization (WHO) Performance, Quality and Safety (PQS) process—two...

    In January 2019, PATH and the Solar Electric Light Fund (SELF) partnered with the government of Senegal to evaluate a smart energy management device attached to certain solar vaccine refrigerators that would enable health workers to use electric devices in areas with limited or unreliable power. Called an energy harvest control (EHC), the device consists of a smart switch that takes excess power generated from solar panels already powering the refrigerators and safely allows the energy to be used for devices such as lights, fans, mobile phones, and some medical devices. The EHC configuration varies by solar direct drive (SDD) refrigerator manufacturer, but each device can access the excess energy, including through USB ports or 12 VDC sockets. The evaluation is taking place in four health posts in the Meckhe and Tivaouane districts of Senegal.

    To date, three EHC devices have been prequalified by the World Health Organization (WHO) Performance, Quality and Safety (PQS) process—two SDD refrigerators with a built-in EHCa,b and one stand-alone systemc paired with a specific SDD refrigerator.d,e

    The need for better electrification

    One study found that of the 11 countries surveyed in sub-Saharan Africa, on average more than one-fourth lacked any access to electricity and close to three-fourths lacked access to a reliable supply of electricity.1 Electrification is a health equity issue—87 percent of those without electricity live in rural areas.2 Studies in Uganda demonstrated that access to midwives and electricity at health facilities had great impact, reducing the maternal fatality rate during emergency obstetric care by as much as 80 percent.3,4

    Our goals for the EHC evaluation

    The evaluation in Senegal will assess whether these EHC devices:

    • Perform according to the WHO PQS specifications in a real-use setting.
    • Are acceptable and useful to end users.
    • Have any unanticipated positive or negative effects on the health system.

    Better health care through energy harvest control

    This evaluation is a step forward in revolutionizing primary health care at the lowest levels of health systems. With the power provided by the EHC, health systems have improved options for:

    • Communication. The ability to charge cell phones, remote temperature monitoring devices, and other small communication devices supports facilities to keep in touch with patients, share data with higher-level facilities, and order supplies.
    • Management of health emergencies. Devices such as lights (for emergencies or births that happen at night)5 and neonatal ultrasound Dopplers for emergency obstetric care are prime examples of how EHC can enable better health care in hard-to-reach areas.
    • Access to health care. By decreasing the amount of time health workers spend away from health facilities charging their devices, health staff can be more available for patient care.
    • Quality of service: Patients must have a high degree of trust in their health centers to rely on them for their health needs, and that trust is either validated by receiving the proper care or broken through negative health interactions associated with a lack of basic equipment. Something as simple as basic lighting can help foster patient trust and improve perceptions regarding the reliability of their health system—and increase the likelihood that patients will seek help when needed.

    Preliminary feedback from health workers

    Users have had a positive response to the electricity provided through the EHC.

    A head nurse noted, “Now they [health workers] get light at night when women are giving birth or when they have urgency—instead of using candles, light from mobile phones, or flashlight lamps.”

    Users generally appreciated the extra power, used some of the study-provided loads, and charged additional loads like mobile phones and radios. The community had more positive perceptions regarding the health services provided by facilities as a result of the EHC devices.

    “From the EHC project,” noted one head nurse, “we now have medical material to better diagnose our patients, especially pregnant women (fetal Doppler, otoscope).”

    Next steps

    We expect to have results from the evaluation in June 2019, and funding has been identified to expand this study to evaluate more EHC devices preparing for PQS pre-qualification. Future work could include market-shaping activities, expanded implementation, and testing and evaluation of equipment that can be used with an EHC.

    Acknowledgement

    PATH acknowledges and appreciates the leadership shown by Steve McCarney in bringing EHC technology to market and his long-time role as champion of solar power for use in low-resource health care facilities.

    Contact

    Steven Diesburg, [email protected]

     

    Footnotes

    a. See http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=9e49ae2f-111c-45fb-a740-3ef325e9e1cd&TipoDoc=DataSheet&ID=0.

    b. See http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=c407d376-4d5e-4f43-a4aa-32f97676dd90&TipoDoc=DataSheet&ID=0.

    c. See http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=ab8a4a27-c68d-4362-8b1b-82bfe9aa573d&TipoDoc=DataSheet&ID=0.

    d. See http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=ef393d19-a915-4937-a10c-0502af93e177&TipoDoc=DataSheet&ID=0.

    e. See http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=02f33f80-ec4a-4e23-9d53-bd9bbed31baa&TipoDoc=DataSheet&ID=0.

     

    References

    1. Adair-Rohani H, Zukor K, Bonjour S, et al. Limited electricity access in health facilities of sub-Saharan Africa: a systematic review of data on electricity access, sources, and reliability. Global Health, Science and Practice. 2013;1(2):249–261. https://doi.org/10.9745/GHSP-D-13-00037.

    2. United Nations Department of Economic and Social Affairs (UNDESA). Analysis of the Voluntary National Reviews Relating to Sustainable Development Goal 7 - 2018. Geneva: UNDESA; 2018. https://sustainabledevelopment.un.org/content/documents/21159DESASDG7_VNR_Analysis2018_final.pdf.

    3. Mbonye AK, Mutabazi MG, Asimwe JB, et al. Declining maternal mortality ratio in Uganda: priority interventions to achieve the Millennium Development Goal. International Journal of Gynaecology and Obstetrics. 2007;98(3):285–290. https://doi.org/10.1016/j.ijgo.2007.05.019.

    4. Mbonye AK, Asimwe JB. Factors associated with skilled attendance at delivery in Uganda: results from a national health facility survey. International Journal of Adolescent Medicine and Health. 2010;22(2):249–155.

    5. Suhlrie L, Bartram J, Burns J, Joca L, Tomaro J, Rehfuess E. The role of energy in health facilities: A conceptual framework and complementary data assessment in Malawi. PLoS One. 2018;13(7):e0200261. https://doi.org/10.1371/journal.pone.0200261.

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  •   Dan Brigden reacted to this post about 5 years ago

    Supply Chain Strategic Focus Area

    Advance the Market Availability of Solar Energy Harvest Control-Equipped Cold Chain Equipment

    Date of notice: April 1, 2019

     

    Summary: Manufacturers of World Health Organization (WHO) Performance, Quality and Safety (PQS) prequalified solar direct drive (SDD) appliances that can be coupled with a market-ready energy harvest control (EHC) option are invited to apply for new product field evaluation support. Selection of participants will be limited to funding available in 2019 with selection priority as follows:

    1. WHO PQS prequalified SDD and WHO PQS prequalified EHC; followed by:
    2. WHO PQS prequalified SDD and EHC with evidence of WHO PQS compliance; followed by:
    3. WHO PQS prequalified SDD and market-ready (i.e., post prototype) EHC.

    Application deadline: May 1, 2019, at 17:00 Pacific Daylight Time (Seattle time)

    Awards decision target date: May 15, 2019

    SDD + EHC shipping date (by manufacturers): July–August 2019

    Project completion target...

    Supply Chain Strategic Focus Area

    Advance the Market Availability of Solar Energy Harvest Control-Equipped Cold Chain Equipment

    Date of notice: April 1, 2019

     

    Summary: Manufacturers of World Health Organization (WHO) Performance, Quality and Safety (PQS) prequalified solar direct drive (SDD) appliances that can be coupled with a market-ready energy harvest control (EHC) option are invited to apply for new product field evaluation support. Selection of participants will be limited to funding available in 2019 with selection priority as follows:

    1. WHO PQS prequalified SDD and WHO PQS prequalified EHC; followed by:
    2. WHO PQS prequalified SDD and EHC with evidence of WHO PQS compliance; followed by:
    3. WHO PQS prequalified SDD and market-ready (i.e., post prototype) EHC.

    Application deadline: May 1, 2019, at 17:00 Pacific Daylight Time (Seattle time)

    Awards decision target date: May 15, 2019

    SDD + EHC shipping date (by manufacturers): July–August 2019

    Project completion target date: March 30, 2020

    1.0 Goals and objectives

    The primary goal of Energy Harvest Field Evaluation Support (“the Project”) is to advance the availability and uptake of WHO PQS prequalified Energy Harvest Control (EHC) systems coupled to WHO PQS prequalified vaccine refrigerators, water-pack freezers, and combined vaccine refrigerator/ice pack freezers.

    It has now been demonstrated that solar direct drive (SDD) appliances coupled with an EHC can meet WHO prequalification requirements for safely harvesting excess SDD electrical energy and provide it for other health facility uses. There is interest in market development support to accelerate uptake of EHC systems. Energy harvesting is a new technology requiring technical support for immunization stakeholders to utilize appropriately. Also, as a new technology, WHO requires manufacturers to pass both a laboratory test and field evaluation for full prequalification. The field evaluation aspect is a newer WHO PQS requirement with significant cost to manufacturers and is an obstacle to market entry.

    To support the goal of advancing the availability and uptake of WHO PQS-prequalified EHC systems, Gavi has funded PATH to: (1) provide technical assistance to immunization stakeholders including Gavi, WHO, UNICEF, and national immunization decision makers on EHC-equipped SDDs and (2) provide support to competitively selected SDD manufacturers for fulfilling the WHO PQS field evaluation requirement. This Project will assess EHC and SDD technical performance, user acceptability, and system fit per WHO PQS field test requirements, including submitting a field evaluation to WHO PQS. PATH will be working with Sunny Day LLC, owned by Steve McCarney, as part of the Project.

    2.0 Project roles and responsibilities

    Manufacturers will be required to apply per this invitation, and provide two complete SDD + EHC system kits including solar power system and any energy consuming loads (e.g., lights) included in, or loads recommended for use with, their kit. The manufacturers must provide the kits free of charge and delivered duty free (Incoterm DDF) to the PATH country office in Senegal, where Round One has been successfully completed. The kits are to include the minimum WHO PQS warranty requirements and will become the property of the host country at the conclusion of the Project, including transfer of warranty provisions to host country.

    Performance monitoring plan and monitoring equipment will be designed, provided, and installed by the Project in consultation with manufacturers. Installation of the SDD system including solar array will be by the manufacturer’s service provider (preferably located in Senegal or the West African region) and their costs will be covered by the Project. The Project and Project consultants will supervise all installation activities. Performance data will not be made public; however, it will be reported to WHO PQS, Gavi, UNICEF Supply Division, the manufacturer, and the Ministry of Health and Social Affairs (MOHSA) of the host country, Senegal.

    The Project will:

    1. Coordinate with the Senegal MOHSA to arrange for necessary approvals, including of sites and in-country partners.
    2. Coordinate with PATH office in country to support field evaluation.
    3. Review, comment, and approve project plan and field evaluation criteria.
    4. Communicate with SDD EHC manufacturer(s).
    5. In consultation with manufacturers, select and provide necessary health facility structural and electrical upgrades, loads, and monitoring devices.
    6. Develop evaluation protocol and obtain necessary research ethics approvals, at PATH and in-country.
    7. Coordinate all field evaluation requirement aspects with WHO PQS.
    8. Provide pre-installation site assessments, installation, and post installation support to service provider.
    9. Monitor field evaluation progress and data collection.
    10. Analyze and report field evaluation data.
    11. Review, comment on, and approve final reports to WHO PQS.
    12. Protect all qualitative and quantitative performance data as confidential, except to the parties noted above (WHO PQS, Gavi, UNICEF Supply Division, and Senegal MOHSA).

    3.0 Application requirements

    Note to repeat applicants from Round One: your applications were sufficiently complete; therefore, please highlight any new information since your Round One application. Several changes are being implemented in Round Two. Your application must include user manuals for both the SDD appliance and the EHC system. If your application is selected, the Project will hire your service provider to: (1) conduct pre-installation site assessments at two health facilities selected by the Project for your specific equipment offering; (2) complete installation at two sites; and (3) return for user training at two sites. Manufacturer to provide outline of user training curriculum at time of application. Service provider to complete manufacturer-supplied commissioning form and submit all forms to PATH.

        3.1 One-page summary of all products offered, appliance PQS code, solar array details, load options required or recommended, and delivery time (PATH office, Dakar, Senegal).

        3.2 Support materials including all installation, maintenance, and user manuals, all component specification sheets (e.g., solar module, solar array support structure, array cable, EHC, EHC battery, and loads if provided) and if the proposed EHC is not yet WHO PQS prequalified, submit test results as evidence of compliance with the PQS   specifications. The application must present SDD appliance user manual, energy harvest user manual, user training curriculum outline, and commissioning forms for both the SDD and for the energy harvest system.

        3.3 Manufacturer must agree in writing to:

    1. All terms and conditions noted in this invitation;
    2. Provide to the Project (at no cost to the Project) two complete systems delivered duty paid to PATH office in Senegal;
    3. Facilitate the contracting of your service provider for aforementioned tasks;
    4. Accept PATH-supplied energy loads (e.g., small fans, lights, fetal heart monitor operating on AA rechargeable batteries, 50 Watt hour Lithium battery packs for user selected loads, etc.);
    5. Relegate reporting responsibility to the Project; and
    6. Keep confidential all performance data, quantitative or qualitative (not to be made public).

        3.4   Firm price quotation for service provider tasks noted above. Project to contract the service support by the manufacturer. 

        3.5   Send applications to [email protected] or [email protected] before 17:00 (Pacific Daylight Time) on May 1, 2019. Questions also should be emailed before 17:00 (Pacific Daylight Time) on May 1, 2019, to [email protected]. Your questions will be answered confidentially by PATH and/or PATH consultant Steve McCarney (directly and confidentially to the requestor).

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  • Dear Rafael,

    Thank you for sharing your information. I made that original post last year and it was intended to solicit equipment suppliers for a study that is now underway in Senegal. Steve McCarney, on this forum,  has conducted EHC evaluations in Columbia and would be a great resource for you to talk to if you are interested.

    Thanks,

    Pat

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  • Pat Lennon added a new resource to the Knowledge Hub
     Freeze-preventive passive containers – technical resources
    This page features background information and guidance on freeze prevention in the immunization supply chain, also known as the cold chain, as it relates to passive containers. Section 1 provides a high-level overview of the impact of freezing vaccines, and Section 2 shares passive technologies that prevent freezing in passive containers and related activities. Sections 3 and 4 contain literature on the effects of freezing temperatures on vaccine potency and instances of freezing in the cold chain. The final section gives additional resources supporting the introduction of new freeze-preventive passive containers.


    Freeze prevention and why it is important
    New freeze-preventive technologies
    Literature on vaccine potency
    Examples of freezing in the cold chain
    Additional information and resources

    1. Freeze prevention and why it is important
    The following resources underscore the negative effects of exposing vaccines to freezing temperatures.

    {khub-list,reference,FREEZE-PREVENTION-BACKGROUND,title ASC, 50}

    2. New freeze-preventive technologies
    The following table contains the activities stakeholders are engaged in to prevent freeze exposure in the supply chain.

    {khub-list,reference,FREEZE-PREVENTION-NEW-TECH,title ASC, 50}

    3. Literature on vaccine potency
    The following resources underscore the negative effects of exposing vaccines to freezing temperatures.

    {khub-list,reference,FREEZE-PREVENTION-POTENCY,title ASC, 50}

    4. Examples of freezing in the cold chain
    The following resources provide examples of freezing in the cold chain.

    {khub-list,reference,FREEZE-PREVENTION-EXAMPLES,title ASC, 50}

    5. Additional resources
    This section contains additional information and related resources.

    {khub-list,reference,FREEZE-PREVENTION-ADDITIONAL-INFO,title ASC, 50}

    Photos left to right: PATH/Simona Zipursky, PATH/Tina Lorenson, PATH/Tina Lorenson.
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