| | All anticipated supplies required to compound a preparation are placed in the primary clean air device before the compounding process begins. |
| | Materials are arranged in the primary clean air device so as to reduce clutter, maximize efficiency of workflow, and avoid interruption of first air. |
| | The critical area in the primary clean air device contains only the supplies that are needed to perform the next activity. |
| | All aseptic compounding is performed at least 15 cm (6 inches) inside the edge of the primary clean air device and at least or within the limits specified by the manufacturer. |
| | Persons performing aseptic technique do not obstruct the supply of first air. |
| | If the supply of first air is obstructed, the critical site is disinfected before other procedures continue. |
| | All nonsterile critical sites (e.g., vial stoppers, necks of unopened ampoules, and bag ports) are disinfected by wiping the site with a single-use, individually wrapped, sterile, low-shedding swab saturated with 70% isopropyl alcohol. |
| | The part of an alcohol swab that will be used to disinfect a critical site is not touched by compounding personnel. |
| | Any alcohol residue on a critical site is allowed to dry before the site is accessed. |
| | Needles and syringes are removed from their protective over-wrap immediately prior to use. |
| | During compounding procedures, the compounder disposes of waste generated inside the primary clean air device by placing it in a waste container located inside the device. |
| | Needles are introduced into vials in a way that minimizes creation of core particulates. |
| | When coring occurs, the liquid is filtered, if the liquid can be filtered, or the product is discarded. |
| | The neck of an ampoule is covered with a freshly opened sterile 70% isopropyl alcohol swab or a clean ampoule breaker before it is opened. |
| | The contents of an ampoule are withdrawn immediately after opening to reduce the likelihood of contamination. |
| | A filter needle is used to either withdraw or inject solution that needs to be filtered, not for both activities. |
| | Filter needles, filter straws, or filters discs are used only for formulations that can withstand filtering. |
| | Tests to ensure filter integrity (e.g., bubble point test) are performed on used filters. |
| | Used syringes, bottles, vials, and other supplies are removed from the critical area in the primary clean air device. |
| | The syringe plunger is a critical site; therefore, when the plunger of a syringe is pulled back, it is gripped only by the distal end (flat part) of the plunger. |
| | The compounder prevents touch contamination of critical sites. |
| | If a critical site is contaminated, the item is appropriately disposed of or disinfected, depending on the product contaminated. |
| | Drug is not aerosolized into the environment. |
| | Syringe tips and needles are covered with sterile caps when not in use. |
| | During compounding, the work surface of the primary clean air device is cleaned before each new batch or every 30 minutes; and after known or suspected contamination. |
| | The exterior surface of the primary container is cleaned immediately before removal of a preparation containing a highly allergenic drug from the primary clean air device. |