POST 00502E : CHILLED WATER PACKS STUDY
Follow-up on Posts 00485E and 00501E
20 September 2002
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Ãœmit Kartoglu (mailto:[log in to unmask]) brings further clarifications on
the chilled waterpacks study.
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Samuel's contribution did not really fit into "chilled water packs study"
as a subject since the study had no intention to go beyond the vaccine
transportation from primary to intermediate vaccine stores and to service
level as well. In his contribution he highlights his concerns on "the use
of cool or wet icepacks during the measles administration after the
reconstitution."
In the original POST00485E, the very first sentence was as follows: "In
Post 00400E (20 December 2001), I asked several questions that led WHO to
conduct a series of studies both in laboratory-controlled and field
conditions using chilled water packs during vaccine transportation." In
this posting, no reference was made to using this technique for outreach
sessions to keep reconstituted vials cold. In this regard, Samuel's
contribution is wrongly questioning the approach. However, the question
could be phrased as whether chilled water packs can be used for conducting
outreach sessions with freeze-dried vaccines, which deserves a different
level of discussion.
The whole idea of the chilled water packs came as an option to prevent
exposure of freeze-sensitive vaccines to freezing temperatures during
vaccine transportation. I have to admit that as a matter of fact
and unfortunately, the use of frozen icepacks without any conditioning
(from freezer directly into the cold box) is still recommended/practiced by
some national immunization services.
In order to prevent any future confusion, I would like to underline once
more the logic behind the study on the use of chilled water packs in
vaccine transportation:
1. Current policy recommends that icepacks be conditioned to have sweat
(beads) on the surface of the icepacks before loading the cold boxes.
However, studies conducted show that with this conditioning method,
vaccines are still in danger of freezing. Field observations also show that
in many cases, frozen icepacks without any conditioning are used for
transportation, thus putting vaccines at greater risk of freezing.
2. "Full conditioning" of icepacks as recommended in the "Guideline for
establishing or improving primary and intermediate vaccine stores"
(POST00400E dated 12 December 2001) was not found practical since it
requires around one hour of conditioning at an ambient temperature of 20°C.
Preliminary discussions with EPI managers during the 9th TFI meeting in
Addis Ababa (December 2001) underlined that the recommended guideline to be
followed is far from being realistic and practical.
3. Chilled water packs are the choice of coolant to accompany
freeze-sensitive vaccines during international vaccine transport. The
validation of packaging/shipping procedures conducted by vaccine
manufacturers shows that chilled water packs can keep vaccines safe even at
a continuous ambient temperature of -5°C for at least 48 hours (inside
temperature not dropping below +2°C).
4. If packed together in the same cold box, there is no technology
available today that provides necessary "cold" temperatures for OPV while
preventing freeze-sensitive vaccines from freezing.
5. The current acceptable exposure period of vaccines to higher
temperatures during transport as indicated by Cold Chain Monitor cards
allows most of the freeze-sensitive vaccines up to 2 weeks at 12°C to 21°C.
Country level vaccine distribution from primary to intermediate stores or
intermediate stores to service levels does not take more than the days
limit set as a rule in Cold Chain Monitoring.
As seen above, the study aims at finding an alternative vaccine
transportation approach to remove the freezing risk.
Those interested in the study protocol, please contact Dr. Ãœmit Kartoglu
directly at :
(mailto:[log in to unmask])
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