What test must personnel pass before working in the compounding area for non-hazardous sterile products?

Personnel must pass the gloved fingertip sampling and media fill test before working in the compounding area for non-hazardous sterile products to ensure they are capable of maintaining the sterility and safety of the compounding process.

The gloved fingertip sampling involves the individual performing a hand hygiene procedure followed by sampling the fingertips of gloved hands to assess contamination. This test helps determine if the individual can adequately maintain the necessary sterile environment, as any microbiological contamination can lead to serious patient harm.

The media fill test, on the other hand, simulates the process of compounding sterile products without the actual active pharmaceutical ingredients. It assesses whether the individual can carry out the procedure without introducing contaminants. If the media remains clear after incubation, it indicates that the individual can perform compounding activities aseptically.

These two tests are critical components of ensuring that personnel possess the necessary skills and understanding of aseptic technique, which is essential for producing sterile products safely and effectively. The correct completion of these tests ensures compliance with regulatory standards and promotes patient safety.