Liquid sterile injectable products that are aliquoted into glass vials must be packaged in vials made of the appropriate type of glass. Quality requirements are described by global pharmacopeia, USP, Ph. Eur., ISO, or ASTM. USP and Ph. Eur. have specified type I glass as borosilicate and type III as soda-lime. Type II is soda-lime treated with ammonium sulfate. Type I is further subcategorized as class A or class B, depending on its thermal expansion properties.[74]
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Final sterile injectable products can be produced by either terminal sterilization once the drug product has been filled into the final container (e.g., vial, syringe, ampoule, cartridge, bag) or via aseptic processing, in which all production steps are performed in a manner that avoids any microbial or other contamination.
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Aseptic fill/finish operations are generally considered to include the final formulation (UF/DF) step followed by sterile filtration, lyophilization if necessary, and filling into the primary packaging. All of these steps must be performed in a manner that precludes any introduction of contaminants, including both microorganisms and particulates.
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Freeze-drying, also called lyophilization, is the process of freezing a solution while simultaneously lowering the pressure to allow the liquid to sublime into vapor. Lyophilization of drug products increases the stability of the active ingredient, whether biologic or small molecule. The elimination of water reduces the weight of the shipment and thereby lowers shipping costs. The final lyophilized product is usually more shelf-stable at room temperature than similar products in aqueous solutions.[80]
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Personalized sterile injectable medicines pose another set of challenges that are increasingly being managed with the use of robots and cobots and the move to fully automated processes that also leverage advanced digital technologies to reduce human errors and increase productivity.[77] The same is true for ophthalmic drugs, which are administered directly into the eye and thus require small-volume doses that require extremely high purity.[87]
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