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THE PHARMA REVIEW (MARCH 2009)

International Packaging and Shipping of Vaccines: Guidelines

M.M. Gupta, Saurabh Kumar Jain1, B.S. Srivastava, Alka Jain, Yadav Rajesh

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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