Joint Committee on Vaccine Storage

  • 1.  Vaccine Storage JC Meeting Summary

    Posted 05-12-2016 06:27 PM
      |   view attached
    Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed. If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. Attachment: 042616 Vaccine Storage JC Summary.docx Description: 042616 Vaccine Storage JC Summary.docx

    Attachment(s)



  • 2.  RE: Vaccine Storage JC Meeting Summary

    Posted 05-12-2016 07:46 PM
    Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From: vs@xxxxxxxxxxxxxxxxx [mailto:vs@xxxxxxxxxxxxxxxxx] On Behalf Of Brooker, Rachel Sent: Thursday, May 12, 2016 2:27 PM To: vs@xxxxxxxxxxxxxxxxx Subject: [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed. If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.


  • 3.  RE: Vaccine Storage JC Meeting Summary

    Posted 05-13-2016 12:02 AM
    Bob, the time is used to re-stock and to do inventory. Three minutes is a long time and I am concerned that could have been an outlier or burp in the measurement system. I agree - hard to design a vertical box to maintain temp for 3 minutes with one wall missing... Perhaps the time needs to be dropped to 1 min which is still a long time with the insistence of some sort of non-buffered audible alarm (based on time or temp or both)  as a staff reminder to close the door. The tem in the box is going to be a function of height of the door and width relative to the total volume - or how fast can the cold air fall out of the box. The study really just looked at the duration of door openings - it might not be possible to design a refrigerator that can overcome poor staff behavior! -Graham   Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC www.coastalchildrens.com   From: vs@xxxxxxxxxxxxxxxxx [mailto:vs@xxxxxxxxxxxxxxxxx] On Behalf Of Robert Turnbull Sent: Thursday, May 12, 2016 3:46 PM To: Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject: [vs] RE: Vaccine Storage JC Meeting Summary   Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From: vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ] On Behalf Of Brooker, Rachel Sent: Thursday, May 12, 2016 2:27 PM To: vs@xxxxxxxxxxxxxxxxx Subject: [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed. If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.


  • 4.  Re: [vs] RE: Vaccine Storage JC Meeting Summary

    Posted 05-13-2016 11:18 AM
    Good morning, the CDC can provide information on the current shipping container that is used for VFC vaccines.  Pharmaceutical companies should also be able to provide insight into these containers.  It may not be totally unusual for a shipment to sit on the receptionist’s desk or on a counter after delivery, until someone can put the vaccine in the storage unit.  Sometimes, those boxes are simply placed in the storage unit intact and then dissembled later.  VFC requires qualified containers and pack outs that are designed to maintain temperature for a given period of time, as long as the box stays closed.  In addition, CDC was also requiring time/temp monitors for heat and freeze exposure. But, Cameron will be the best resource for insight into this. Pat On May 12, 2016, at 8:01 PM, Dr. Graham Barden < DrBarden@xxxxxxxxxxxxxxxxxxxx > wrote: Bob, the time is used to re-stock and to do inventory. Three minutes is a long time and I am concerned that could have been an outlier or burp in the measurement system. I agree - hard to design a vertical box to maintain temp for 3 minutes with one wall missing... Perhaps the time needs to be dropped to 1 min which is still a long time with the insistence of some sort of non-buffered audible alarm (based on time or temp or both)  as a staff reminder to close the door. The tem in the box is going to be a function of height of the door and width relative to the total volume - or how fast can the cold air fall out of the box. The study really just looked at the duration of door openings - it might not be possible to design a refrigerator that can overcome poor staff behavior! -Graham   Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC www.coastalchildrens.com   From:   vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Robert Turnbull Sent:   Thursday, May 12, 2016 3:46 PM To:   Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject:   [vs] RE: Vaccine Storage JC Meeting Summary   Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From:   vs@xxxxxxxxxxxxxxxxx   [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Brooker, Rachel Sent:   Thursday, May 12, 2016 2:27 PM To:   vs@xxxxxxxxxxxxxxxxx Subject:   [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email:   rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed.   If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in   this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.


  • 5.  RE: [vs] RE: Vaccine Storage JC Meeting Summary

    Posted 05-13-2016 11:49 AM
      |   view attached
    Good Morning,   I can confirm that we (CDC) use qualified containers and pack outs for our shipments.  I agree with Dr. Barden that we may need to drop the time down from 3 minutes. I know on our last call we talked about maybe focusing more heavily on recovery time as opposed to maintaining temp. Maybe we can discuss this more on the next call.   Thanks,   Sean         Sean R. Trimble Vaccine Supply and Assurance Branch Immunization Services Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Phone: 404-639-8667 Blackberry: 404-852-8443 When telecommuting on Wednesdays/Fridays, I may be reached by email or phone at 404.852.3443         From: vs@xxxxxxxxxxxxxxxxx [mailto:vs@xxxxxxxxxxxxxxxxx] On Behalf Of Patricia Beckenhaupt Sent: Friday, May 13, 2016 7:18 AM To: Dr. Graham Barden <DrBarden@xxxxxxxxxxxxxxxxxxxx> Cc: Robert Turnbull <RTurnbull@xxxxxxxxxxxxx>; Brooker, Rachel <rbrooker@xxxxxxx>; vs@xxxxxxxxxxxxxxxxx Subject: Re: [vs] RE: Vaccine Storage JC Meeting Summary   Good morning, the CDC can provide information on the current shipping container that is used for VFC vaccines.  Pharmaceutical companies should also be able to provide insight into these containers.  It may not be totally unusual for a shipment to sit on the receptionist’s desk or on a counter after delivery, until someone can put the vaccine in the storage unit.  Sometimes, those boxes are simply placed in the storage unit intact and then dissembled later.  VFC requires qualified containers and pack outs that are designed to maintain temperature for a given period of time, as long as the box stays closed.  In addition, CDC was also requiring time/temp monitors for heat and freeze exposure.   But, Cameron will be the best resource for insight into this.   Pat On May 12, 2016, at 8:01 PM, Dr. Graham Barden < DrBarden@xxxxxxxxxxxxxxxxxxxx > wrote: Bob, the time is used to re-stock and to do inventory. Three minutes is a long time and I am concerned that could have been an outlier or burp in the measurement system. I agree - hard to design a vertical box to maintain temp for 3 minutes with one wall missing... Perhaps the time needs to be dropped to 1 min which is still a long time with the insistence of some sort of non-buffered audible alarm (based on time or temp or both)  as a staff reminder to close the door. The tem in the box is going to be a function of height of the door and width relative to the total volume - or how fast can the cold air fall out of the box. The study really just looked at the duration of door openings - it might not be possible to design a refrigerator that can overcome poor staff behavior! -Graham   Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC www.coastalchildrens.com   From:   vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Robert Turnbull Sent:   Thursday, May 12, 2016 3:46 PM To:   Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject:   [vs] RE: Vaccine Storage JC Meeting Summary   Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From:   vs@xxxxxxxxxxxxxxxxx   [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Brooker, Rachel Sent:   Thursday, May 12, 2016 2:27 PM To:   vs@xxxxxxxxxxxxxxxxx Subject:   [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email:   rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed.   If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in   this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.  


  • 6.  Re: [vs] RE: Vaccine Storage JC Meeting Summary

    Posted 05-13-2016 12:03 PM
    Some of the info is misleading on shipping containers. Frozen vaccine used to be shipped frozen when dry ice was used. Now that is no longer used and Varivax is not shipped frozen.  I think Bob was more concerned with maintaining 2-8C in a refrigerator with the door open for 3 min. I suspect the lower 2/3's of a shipping container box can maintain temp with the lid open for that duration. Much longer when not open.  Unfortunately I think most of these issues could be avoided with a distinction between "storage" at 2-8c  and "active management" of stock. Other countries (Australia) allow brief 10 min temp excursions during active management of stock. But I do not see the FDA helping with a distinction between storage and manipulation.  We must be most concerned with accidental undetected freezing.  Graham Sent from my iPodTouch On May 13, 2016, at 07:18, Patricia Beckenhaupt < pbeckenhaupt@xxxxxxxxx > wrote: Good morning, the CDC can provide information on the current shipping container that is used for VFC vaccines.  Pharmaceutical companies should also be able to provide insight into these containers.  It may not be totally unusual for a shipment to sit on the receptionist’s desk or on a counter after delivery, until someone can put the vaccine in the storage unit.  Sometimes, those boxes are simply placed in the storage unit intact and then dissembled later.  VFC requires qualified containers and pack outs that are designed to maintain temperature for a given period of time, as long as the box stays closed.  In addition, CDC was also requiring time/temp monitors for heat and freeze exposure. But, Cameron will be the best resource for insight into this. Pat On May 12, 2016, at 8:01 PM, Dr. Graham Barden < DrBarden@xxxxxxxxxxxxxxxxxxxx > wrote: Bob, the time is used to re-stock and to do inventory. Three minutes is a long time and I am concerned that could have been an outlier or burp in the measurement system. I agree - hard to design a vertical box to maintain temp for 3 minutes with one wall missing... Perhaps the time needs to be dropped to 1 min which is still a long time with the insistence of some sort of non-buffered audible alarm (based on time or temp or both)  as a staff reminder to close the door. The tem in the box is going to be a function of height of the door and width relative to the total volume - or how fast can the cold air fall out of the box. The study really just looked at the duration of door openings - it might not be possible to design a refrigerator that can overcome poor staff behavior! -Graham   Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC www.coastalchildrens.com   From:   vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Robert Turnbull Sent:   Thursday, May 12, 2016 3:46 PM To:   Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject:   [vs] RE: Vaccine Storage JC Meeting Summary   Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From:   vs@xxxxxxxxxxxxxxxxx   [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Brooker, Rachel Sent:   Thursday, May 12, 2016 2:27 PM To:   vs@xxxxxxxxxxxxxxxxx Subject:   [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email:   rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed.   If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in   this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.


  • 7.  RE: [vs] RE: Vaccine Storage JC Meeting Summary

    Posted 05-13-2016 12:11 PM
    What is a “Qualified Container”?   Bob Turnbull Staff Engineer AGA Marvel   From: Patricia Beckenhaupt [mailto:pbeckenhaupt@xxxxxxxxx] Sent: Friday, May 13, 2016 7:18 AM To: Dr. Graham Barden Cc: Robert Turnbull; Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject: Re: [vs] RE: Vaccine Storage JC Meeting Summary   Good morning, the CDC can provide information on the current shipping container that is used for VFC vaccines.  Pharmaceutical companies should also be able to provide insight into these containers.  It may not be totally unusual for a shipment to sit on the receptionist’s desk or on a counter after delivery, until someone can put the vaccine in the storage unit.  Sometimes, those boxes are simply placed in the storage unit intact and then dissembled later.  VFC requires qualified containers and pack outs that are designed to maintain temperature for a given period of time, as long as the box stays closed.  In addition, CDC was also requiring time/temp monitors for heat and freeze exposure.   But, Cameron will be the best resource for insight into this.   Pat On May 12, 2016, at 8:01 PM, Dr. Graham Barden < DrBarden@xxxxxxxxxxxxxxxxxxxx > wrote: Bob, the time is used to re-stock and to do inventory. Three minutes is a long time and I am concerned that could have been an outlier or burp in the measurement system. I agree - hard to design a vertical box to maintain temp for 3 minutes with one wall missing... Perhaps the time needs to be dropped to 1 min which is still a long time with the insistence of some sort of non-buffered audible alarm (based on time or temp or both)  as a staff reminder to close the door. The tem in the box is going to be a function of height of the door and width relative to the total volume - or how fast can the cold air fall out of the box. The study really just looked at the duration of door openings - it might not be possible to design a refrigerator that can overcome poor staff behavior! -Graham   Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC www.coastalchildrens.com   From:   vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Robert Turnbull Sent:   Thursday, May 12, 2016 3:46 PM To:   Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject:   [vs] RE: Vaccine Storage JC Meeting Summary   Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From:   vs@xxxxxxxxxxxxxxxxx   [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Brooker, Rachel Sent:   Thursday, May 12, 2016 2:27 PM To:   vs@xxxxxxxxxxxxxxxxx Subject:   [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email:   rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed.   If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in   this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.   This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.


  • 8.  RE: [vs] RE: Vaccine Storage JC Meeting Summary

    Posted 05-13-2016 12:18 PM
    The simple definition for a qualified container/packout is that the container/packout was tested or qualified in a lab setting.   Sean     From: vs@xxxxxxxxxxxxxxxxx [mailto:vs@xxxxxxxxxxxxxxxxx] On Behalf Of Robert Turnbull Sent: Friday, May 13, 2016 8:10 AM To: Patricia Beckenhaupt <pbeckenhaupt@xxxxxxxxx>; Dr. Graham Barden <DrBarden@xxxxxxxxxxxxxxxxxxxx> Cc: Brooker, Rachel <rbrooker@xxxxxxx>; vs@xxxxxxxxxxxxxxxxx Subject: RE: [vs] RE: Vaccine Storage JC Meeting Summary   What is a “Qualified Container”?   Bob Turnbull Staff Engineer AGA Marvel   From: Patricia Beckenhaupt [ mailto:pbeckenhaupt@xxxxxxxxx ] Sent: Friday, May 13, 2016 7:18 AM To: Dr. Graham Barden Cc: Robert Turnbull; Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject: Re: [vs] RE: Vaccine Storage JC Meeting Summary   Good morning, the CDC can provide information on the current shipping container that is used for VFC vaccines.  Pharmaceutical companies should also be able to provide insight into these containers.  It may not be totally unusual for a shipment to sit on the receptionist’s desk or on a counter after delivery, until someone can put the vaccine in the storage unit.  Sometimes, those boxes are simply placed in the storage unit intact and then dissembled later.  VFC requires qualified containers and pack outs that are designed to maintain temperature for a given period of time, as long as the box stays closed.  In addition, CDC was also requiring time/temp monitors for heat and freeze exposure.   But, Cameron will be the best resource for insight into this.   Pat On May 12, 2016, at 8:01 PM, Dr. Graham Barden < DrBarden@xxxxxxxxxxxxxxxxxxxx > wrote:   Bob, the time is used to re-stock and to do inventory. Three minutes is a long time and I am concerned that could have been an outlier or burp in the measurement system. I agree - hard to design a vertical box to maintain temp for 3 minutes with one wall missing... Perhaps the time needs to be dropped to 1 min which is still a long time with the insistence of some sort of non-buffered audible alarm (based on time or temp or both)  as a staff reminder to close the door. The tem in the box is going to be a function of height of the door and width relative to the total volume - or how fast can the cold air fall out of the box. The study really just looked at the duration of door openings - it might not be possible to design a refrigerator that can overcome poor staff behavior! -Graham   Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC www.coastalchildrens.com   From:   vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Robert Turnbull Sent:   Thursday, May 12, 2016 3:46 PM To:   Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject:   [vs] RE: Vaccine Storage JC Meeting Summary   Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From:   vs@xxxxxxxxxxxxxxxxx   [ mailto:vs@xxxxxxxxxxxxxxxxx ]   On Behalf Of   Brooker, Rachel Sent:   Thursday, May 12, 2016 2:27 PM To:   vs@xxxxxxxxxxxxxxxxx Subject:   [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email:   rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed.   If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in   this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.   This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.


  • 9.  RE: Vaccine Storage JC Meeting Summary

    Posted 05-13-2016 12:21 PM
    Graham I understand why it takes three minutes to load.  My comments are more about the process before the refrigerator door is even open.  If a vaccine can withstand temperature swings during transportation (which I assume it does), than designing a refrigerator to withstand minimal swings might be overdesigning.  I would like to think that once the vaccine enters the refrigerator it will be in one of the most stable environments between the time it leaves the pharmaceutical manufacture until time of use. I have seen vaccines sit on a table in a 72-74F examination room for 15 minutes waiting to be injected.  Compare that to a minute or so over the 8C threshold, and it is a totally different ball game. I have been trying to listen to everyone to understand the process from manufacture to injection.  I believe the refrigerator will be the most important part of the chain.  The vaccine will be stored there the longest so there for it needs to be the most stable. But 3 or even 2 minutes with bare thermocouples (which still needs to be defined), and cannot exceed 8C, I am thinking about crying foul.   Maybe it is just too early for me to be thinking.  I need another cup of tea.   Bob Turnbull Staff Engineer AGA Marvel   From: vs@xxxxxxxxxxxxxxxxx [mailto:vs@xxxxxxxxxxxxxxxxx] On Behalf Of Dr. Graham Barden Sent: Thursday, May 12, 2016 8:01 PM To: Robert Turnbull; Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject: [vs] RE: Vaccine Storage JC Meeting Summary   Bob, the time is used to re-stock and to do inventory. Three minutes is a long time and I am concerned that could have been an outlier or burp in the measurement system. I agree - hard to design a vertical box to maintain temp for 3 minutes with one wall missing... Perhaps the time needs to be dropped to 1 min which is still a long time with the insistence of some sort of non-buffered audible alarm (based on time or temp or both)  as a staff reminder to close the door. The tem in the box is going to be a function of height of the door and width relative to the total volume - or how fast can the cold air fall out of the box. The study really just looked at the duration of door openings - it might not be possible to design a refrigerator that can overcome poor staff behavior! -Graham   Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC www.coastalchildrens.com   From: vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ] On Behalf Of Robert Turnbull Sent: Thursday, May 12, 2016 3:46 PM To: Brooker, Rachel; vs@xxxxxxxxxxxxxxxxx Subject: [vs] RE: Vaccine Storage JC Meeting Summary   Rachel I am sorry I missed last week’s meeting I was out on vacation.  Reading through the notes I noticed something.  We talk about the importance of the refrigerator going over 8C with a 3 minute door opening, and how the 3 minutes could happen during weekly loading.  Being one that is not familiar with loading process, how does the vaccines arrive to the office or store and what is the temperature before loading into the refrigerator?  I assume these come on a UPS truck in a EPS foam box or cooler with or without some sort of ice pack. I cannot believe these boxes of vials sitting on the floor waiting to be installed into the refrigerator are holding this temperature. With that being said, I am concerned why the refrigerator has to way our perform the entire process. Unless someone can explain to me how the process is holding this temperature range, I don’t feel you are being fair to the manufactures to hold a temperature that the process is not holding.   Bob Turnbull Staff Engineer AGA Marvel   From: vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ] On Behalf Of Brooker, Rachel Sent: Thursday, May 12, 2016 2:27 PM To: vs@xxxxxxxxxxxxxxxxx Subject: [vs] Vaccine Storage JC Meeting Summary   Hello Vaccine Storage Joint Committee,   I have completed the draft summary for the last JC meeting. It has been uploaded to the NOW as well as attached here. Please let me know if you have any questions or comments. Thanks, Rachel   Rachel M. 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