Keeping it up to standards – achieving sterility and pyrogen-free solutions

Like any pharmaceutical dosage form, parenterals must meet pharmaceutical quality standards to be considered safe for their intended use. Two main requirements for parenteral solutions are to be sterile and free from pyrogenic contamination.  Processes include sterilizing of equipment and containers using sterile filterers and autoclaves or radiation, and depyrogenation, which uses depyrogenation tunnels to remove bacterial endotoxins and other pyrogens.

To ensure that sterility is achieved, methods such as direct inoculation, membrane filtration, bacteriostasis/ fungistasis (B/F), and vaporized hydrogen peroxide (VHP) ingress testing are used. These methods test the samples for any presence of aerobic and anaerobic microorganisms, assess the possible growth of microorganisms, and validate sterility results.

Formulation challenges when making parenterals: from excipient compatibility to pH value

In addition to being sterile and pyrogen-free, parenteral preparations may need excipients that are biocompatible. These excipients are selected for their appropriate use such as making parenteral preparations isotonic with the patient’s blood to prevent hemolysis or damage to cells and tissues. They can be used to adjust the pH level of the solution and maintain product stability and solubility. Other functions include providing adequate antimicrobial properties for multidose preparations.

Parenteral filling equipment in an aseptic environment

Parenterals are filled in ampoules, vials, syringes, cartridges, bottles, and bags. The entire process must be done under aseptic environment conditions to avoid contamination in which producers need to sterilize containers before the filling process. Isolators are placed around filling machines to separate the processing area from the environment combined with an automated sanitization system using hydrogen peroxide to decontaminate the area.