TechNet-21 - Forum

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  1. Michelle Seidel
  2. Cold chain equipment
  3. Tuesday, 28 May 2019

Dear TechNet-21 Community,

Following the WHO PQS statement on the Vestfrost investigation, please find attached guidance on the management of the equipment and vaccines. Thank you.

Michelle Seidel

Immunization Supply Chain, Programme Division Office: +45 45 33 56 12, Mobile : +45 30 78 76 54, E-mail: mseidel@unicef.org 

United Nations Children’s Fund UN City,Marmovej 51,Copenhagen, Denmark

Follow us on Facebook, Twitter, YouTube and at www.unicef.org 

Attachments (2)
References
  1. http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=5a4cd0be-1468-499b-88e6-b3a226d17e50&TipoDoc=PQS_x0020_Document_x0020_Type&GuidDoc=133bd3e3-99d6-40b9-b6d0-5e653b15e80b
  2. https://www.who.int/immunization/documents/financing/who_ivb_15.04
Larry Schlussler Accepted Answer
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Hi Denise

Thank you for the clarification on PQS allowed temperature swings. Previously no temperatures swings below 2 Deg C were allowed. I also received a clarification from Isaac.

For the day/night temperature tests MKT temperature is used to acess the cumulative effect of temperature excursions. I think it  would also be benefical to assess the effect of temperature excursions in the stable run tests using MKT temperatures. If for example each night the temperature went to 12 Deg C for two hours,  the MKT temperature could still be below 2 Deg C  and the life of the vaccine would be uneffected. Having temperature limits which are unnecessarly restricitive at one end of the temperature scale may make it difficult for manufactures to meet the temperature requirments at  the other end of the temperature scale.

Larry

Sun Frost

 

Denise Accepted Answer
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Dear Larry, 

 

Have you reviewed the WHO PQS testing protocols for fridges and freezers on the PQS website? I have shared a couple of protocol links and attachments for ease of reference: 

PQS testing protocols list criterias for qualification, including acceptable temperature ranges that are defined as follows:

Acceptable temperature range: The acceptable temperature range for storing vaccine is +2°C to +8°C. However, transient excursions outside this range will be tolerated, within the following limits:

  • No excursion must exceed +20°C (± 0.5°C) for any amount of time.
  • No excursion must drop below -0.5°C for any amount of time.
  • No excursion must drop below 0°C for longer than 1 hour.
  • Following an excursion below 0°C, the appliance must return to safe operating temperature (i.e., consistently between +2°C and +8°C) within 2 hours. This duration will be measured from the moment the temperature drops below 0°C and up until it returns to +2°C.

The cumulative effect of any excursions within the above range will be assessed over the five day period of the day/night test. For this test, the calculated mean kinetic temperature (MKT) must remain within the range +2°C to +8°C when the default activation energy is set at 83,144 kJ per mol. Using the recorded temperature data, an MKT figure will be calculated for each sensor. The worst-case result will determine the outcome of the test. Excursions in other tests will be noted and must not exceed the defined upper and lower limits.

I hope this helped answer your questions!

Best wishes,

Denise 

Attachments (2)
Larry Schlussler Accepted Answer
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Hi Michelle

I realize that freezing is not allowed in the refrigerator compartment. What I was asking was what exactly the PQS  test standards are; are certain temporary excursions below 2 deg C allowed during a PQS test.

Larry

Sun Frost

 

 

 

Michelle Seidel Accepted Answer
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Dear Ian,

Not all Vestfrost Equipment has been delisted- please find the affected models  here.

No Haier products have been withdrawn from PQS due to performance or quality complaints.

Dear Larry,

Freezing is not acceptable in the refrigeration compartment, obviously in the freezer this is acceptable.

 

ian.tansley Accepted Answer
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Hi Larry

My understanding is that ALL Vestfrost refrigerators have been struck off the WHO PQS list as a result of the discovery of frequent freezing conditions in the refrigerator compartment. 

Did I hear someone say that some Haier product has also been de-listed?

Ian

Larry Schlussler Accepted Answer
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After reading the WHO statement I was not clear on exactly what the PQS standards are:

does the refrigerator have to stay between 2 deg C and 8 deg C or is the the freezer allowed

to go to -5 deg  C for less than 1 hour. Could some one please clarify.

Carlton Banks Accepted Answer
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Dear Rafael,

WHO have posted further information on their PQS website providing user guidance and informing the applicable Vestfrost products have been suspended from the PQS list pending their investigation.

 

 

References
  1. https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=5a4cd0be-1468-499b-88e6-b3a226d17e50&TipoDoc=PQS_x0020_Document_x0020_Type&GuidDoc=478c2315-94b4-4eeb-afd5-2dcc1bfb93ae
  2. https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=5a4cd0be-1468-499b-88e6-b3a226d17e50&TipoDoc=PQS_x0020_Document_x0020_Type&GuidDoc=eff43e2d-f512-4ada-88d9-aa770a2be132
Michelle Seidel Accepted Answer
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Dear Rafael,

 

Thank you for the information.

Vestfrost has submitted a report to PQS. Their findings are currently being independently verified. PQS should have an update soon. 

  1. more than a month ago
  2. Cold chain equipment
  3. # 8
0
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Dear Michelle

Has Vestfrost given the explanation about that situation? In Colombia we have those equipments working well (ILR and SDD). 

Best regards

  1. more than a month ago
  2. Cold chain equipment
  3. # 9


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