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.
1. CDC, "Vaccine Price List,"
http://www.cdc.gov/, accessed Oct. 14, 2011.
2. UNICEF, "Vaccine Price Data 2001-2010,"
http://www.unicef.org/, accessed Oct. 14, 2011
3. President's Council of Advisors on Science and Technology, "Report to the President on Reengineering the Influenza Vaccine
Production Enterprise to Meet the Challenges of Pandemic Influenza" (Aug. 2010).
4. ISO 14644-1, Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanlines Cleanroom Standards
5. European Commission, EudraLex Vol. 4: Good manufacturing practice (GMP) Guidelines, Annex 1: Manufacture of Sterile Medicinal
6. S. Chalk et al., BioPharm Intl. 24 (8) 44–65 (2011).
7. Newberger et al., Pharm. Eng. 28 (6), 1–7 (2008).