CONCLUSION
Process closure provides superior product protection and permits lower room classifications. A risk-based approach must be
used to review the state of process system closure and to identify all connection points, evaluating their suitability with
regard to the process and quality requirements. Manufacturing facilities that use these closed-system processes in combination
with single-use technologies offer process flexibility; adaptable and expandable design; shortened construction, start-up,
and validation schedules; as well as decreased utility costs, all of which have the potential to reduce the cost of vaccines.
REFERENCES
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2. UNICEF, "Vaccine Price Data 2001-2010,"
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4. ISO 14644-1, Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanlines Cleanroom Standards
(ISO, 1999).
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