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Quality Management of the Cold Chain - Seminar on VVM Implementation held by Sinopharm in Changchun  

sinopharm.com -"Jun 22nd, 2010, Sinopharm held Quality management of the cold chain – seminar on VVM implementation in Changchun. Leaders from MoH Disease Control Bureau Immunization Planning and Management Division, SFDA Drug Registration Bureau, CDC National Immunization Program Planning Center, NICPBP, Jilin Provincial FDA, Jilin Provincial CDC, as well as experts from WHO, PATH and US Temptime Corporate attended the seminar." (read more - Chinese)(read more - English)


Identifying Cumulative Heat Exposure of Temperature Sensitive Medical Products   

rx360.com - "This article focuses on a method to identify mean kinetic temperature (MKT) exposure of heat-sensitive medical products and highlights the outstanding results achieved by the World Health Organization (WHO) and several Ministries of Health when a robust, miniaturized technology is used to monitor the MKT of each vial of life-saving vaccine. This technology is now adapted to monitor the heat stability of most biologicals, pharmaceuticals and medical devices." (read more)


Majority of Physicians Concerned about Risks to Patients from Heat Damaged Products   

reuters.com - "In a recent Harris Interactive survey of US physicians about the proper storage and handling of temperature-sensitive medicines prescribed and administered to patients, physicians reported being concerned about this issue, and the overwhelming majority are concerned that heat-damaged products resulting from cumulative exposure to temperatures outside the specified temperature range pose a health risk to patients. The announcement of the study findings was made today by Temptime Corporation." (read more)


Can Your Cold Chain Hurt Your Company's Brand?    

 lifescienceleader.com - "Regulators are asking pharma/biopharma companies more detailed questions about how their products are transported and stored from the point of manufacture to final delivery. Auditable records of what process was used to transport a drug and what materials were used to protect and control the temperature of the shipment are becoming the norm." (read more)


Using Oral Polio Vaccine Beyond the Cold Chain: A Feasibility Study conducted during the National Immunization Campaign in Mali.

pubmed.gov - "Using a crossover intervention design, vaccinators compared the transport of OPV in vaccine carriers with or without ice packs. Vaccine integrity was assured through monitoring vaccine vial monitor (VVM) status. Despite ambient temperatures up to 40 degrees C, none of the VVMs on any of the vials used (n=956) reached their discard point. (read more)


VVMs required by India's Ministry of Health

rx360.com - On 24 November, the Government of India’s Ministry of Health (Department of Family Welfare) issued a requirement specifying the use of vaccine vial monitors (VVMs) on OPV, measles, BCG, DPT and TT purchased vaccines.  VVMs are time-temperature indicators based on Mean Kinetic Temperature and are correlated to the stability of the given vaccine.  VVMs are supplied by Temptime Corporation (www.temptimecorp.com) and were developed to meet WHO-UNICEF requirements for a cumulative time-temperature indicator that accurately shows the limit of the vaccine’s use, is small enough to be affixed to each vial, and can be commercialized in the large volumes necessary with strict quality controls.  VVMs reliably enable healthcare workers to identify vaccines that have been damaged by heat – in order to avoid their administration to patients – and distinguish vaccines that have been exposed to potentially damaging heat but are still effective for use, thus avoiding costly waste.  To view the full specifications, please see:  http://mohfw.nic.in/Clarifications.doc (Link)


Temptime's Freeze Indicator To Be Used on US H1N1 Vaccines  

medicalnewstoday.com - "Temptime Corporation announced today that its FREEZEmarker® temperature indicator has been selected for use on H1N1 vaccines scheduled to be distributed in the US later this year." (Read More)


Temptime Donates Vaccine Vial Monitors to Support WHO Distribution of H1N1 Vaccine to Developing Countries Most in Need

finance.yahoo.com - "Temptime Corporation announced today that it will donate its Vaccine Vial Monitors (VVMs) to the World Health Organization (WHO) to monitor potential heat damage of H1N1 vaccines to be distributed by WHO to developing countries most in need."  (Read More)

  
Video: "One Life at a Time" 

youtube.com - "This video vignette describes how the vaccine vial monitor reassures health workers that vaccine is safe and effective—or alerts them that vaccine has been damaged by heat on the long journey from a European manufacturing plant to a remote village in Kenya." (Video)