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THE PHARMA REVIEW
(MARCH 2009) |
International Packaging and
Shipping of Vaccines: Guidelines
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M.M. Gupta, Saurabh Kumar
Jain1, B.S. Srivastava, Alka Jain, Yadav Rajesh |
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Introduction: The Guidelines for international
packaging and shipping of vaccines, was first published
in 1990. Since then it has gone through four revisions:
in 1995, 1998, 2001, and 2005. The revision which was
approved in, December 2005, replaces all previous
versions. The World Health Organization (WHO) provided
the Guidelines on the international packaging and
shipping of vaccines, has been one of the most widely
used manuals in the field of immunization. It is
referenced by UNICEF (United Nations Children's Fund)
and PAHO (Pan American Health Organization). This 2005
edition takes into account the new developments in the
field of vaccine stability, temperature monitoring and
information on recently pre-qualified vaccines. A
special section on temperature monitoring has been added
to describe the temperature limits for international
shipments.
Insulated Packaging Standards
On the basis of their thermo-stability and presentation,
vaccines are classified into three categories (see Table
1) for packaging of international shipments. WHO
specifies the minimum and maximum acceptable
temperatures to which vaccines in each category can be
exposed during international transport, for a period of
at least 48 hours. - Class A Packaging, Class B
Packaging, Class C Packaging
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