On-Site Clean provides consistent, objective observations and sampling under dynamic conditions to support Compounding Personnel Competencies, including:

• Hand Hygiene and Garbing with gloved fingertip testing

• Media Fill Simulations with post-fingertip sampling and surface sampling of the DCA

Compounding standards and regulations, as established by the USP, FDA, and State Boards of Pharmacy, have evolved to require enhanced oversight of environmental controls and personnel competency. Under USP standards <795>, <797>, <800>, and <825>, this responsibility now falls to the Designated Person (DP), who is accountable for the facility’s performance and the competency of its personnel. Key DP responsibilities include:

• Developing and implementing a comprehensive training program for all aspects of the compounding environment

• Conducting or delegating training and competency observations

• Ensuring all areas related to compounded preparations meet quality standards (ISO classification, air pressures, temperature, humidity, environmental sampling, cleaning techniques)

• Establishing and maintaining formal written QA and QC programs

On-Site Clean specializes in supporting this compliance journey. We have long been a trusted partner, providing trained and qualified personnel to properly clean ISO and non-ISO spaces, including HD and non-HD suites, in both sterile and non-sterile facilities.