Page 106 - Assurance of Sterility for Sensitive Combination Products and Materials

90 Assurance of sterility for sensitive combination products and materials

Fig. 5.3 Glass vial—example of a multidose container. iStock.com/FreezeFrameStudio

increased bioavailability by bypassing the skin, however, it introduces addi-
tional challenges for package development. In addition to maintenance of
sterility, parenteral delivery requires controls to minimize particulates, en-
dotoxins, extractables, and leachables. Examples of containers and closures
for parenterals include plastic IV bags, prefilled syringes, vials, and ampules.
The USP lists five primary types of preparations intended for parenteral
administration:
• Injection: liquid preparations that are drug substances or drug
solutions
• For injection: dry solids that upon reconstitution, yield solutions that must
meet all requirements for injections
• Injectable emulsions: liquid preparations of drug substances dissolved or
dispersed in a suitable emulsion
• Injectable suspension: liquid preparations of solids suspended in a suitable
liquid
• For Injectable suspension: dry solids that, upon addition of suitable vehi-
cles, yield preparations conforming in all respects to the requirements of
injectable suspensions [28] (Fig. 5.4 and Table 5.3)