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Pharmaceutical requirements
During manufacture Sterility
• Since human beings are frequently the
principal source of microbial contamination
in the manufacturing environment, their
health, hygiene, clothing and training may
all have an impact on product
contamination.
• Sterile manufacturing equipment, such
as flasks, connecting tubes, and filters.
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Pharmaceutical requirements Sterility
Post-manufacture
• Terminal sterilization post-manufacture is essential, preferably in final
marketed sealed containers.
• The method is determined largely by the nature of the preparation
and its ingredients.
• The resulting product must pass a test for sterility as proof of the
effectiveness of the method and the performance of the equipment
and personnel.
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Salma E. EL-Habashy 29
