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Preparation of parenteral drugs, either LVPs or SVPs, demands the highest level of contamination control, because the human body’s normal defenses against infection are bypassed when parenteral medications are introduced either intramuscularly (I.M.) or intravenously (I.V.) directly into the body. The processing of raw materials into finished dosage forms must comply at all times with cGMPs and must be able to support process validation. Mechanical design should include HVAC Classifications considered essential to attain global regulatory acceptance. For classifications see the ISPE® Guide for Sterile Manufacturing Facilities.
The desire for increased levels of sterility assurance has led the FDA to promote the use of terminal sterilization for aseptically filled products. The FDA has stated that terminal sterilization processing is the method of choice unless the manufacturer can show that it is detrimental to the product. Terminal sterilization may be accomplished using autoclaves that apply overpressure to balance the pressures that are developed across the inside and outside of the containers. Because of product sensitivities, biologics and blood products are not appropriate applications for terminal sterilization.
See also: Terminal Sterilization
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