Is fingertip testing required with isolators used outside of a cleanroom?

Yes, <797> requires that sterile gloves be worn inside the fixed isolator sleeves, just as they are required within a hood or biological safety cabinet. This is based on the committee’s expectation that any glove that could potentially touch a critical site must be sterile. Therefore, glove fingertip testing must be conducted. Typically, this testing can be included as part of the individual employee’s media fill testing.

Many isolators come with heavy-duty rubber gloves, but I recommend replacing those with regular non-sterile gloves with a long cuff that can be attached to the gauntlets to serve as the fixed sleeves. In this setup, the user would don a pair of sterile gloves as part of their daily setup, thus meeting the guidelines. Determining how often to change gloves is a common challenge in the pharmacy. At a minimum, sterile gloves used inside the chamber should be changed at least once a day if not more frequently. Keep in mind that if components brought into the isolator are not properly disinfected first, external contamination is transferred to the inside of the isolator and then after touching the component with your gloves, any subsequent poor technique, such as touching a needle, hub, or vial septum, could result in direct contamination of the compounded product.