Are You In Compliance?
The new USP797 guidelines are in effect in November 2023. Are your sterile compounding facilities in compliance?
The MTA family of companies can perform a gap analysis of your sterile compounding facilities to meet the new USP specifications. Our OAR or “Operational Analysis & Reporting” program does a deep dive into your Secondary Engineering Control or SEC mechanical and structural integrity for compliance.
Our SME will identify cosmetic problems to ensure a smooth and impermeable structure and provide solutions and/or corrective action plans to remedy the situation. These can be carried out by the MTA clean room carpentry team or your local provider. In addition, our SMEs are HVAC trained to find solutions to your mechanical needs. Are you fighting with temperature and humidity compliance?
- Are you out of specifications more often than in?
- Are your monthly environmental sampling plans failing regularly?
- Are your room’s pressures not in specifications or too high? (MTA suggests between 0.02” & 0.07” WC) for optimal performance.
- Do you need room monitoring equipment for temperature, humidity, and pressure?
MTA can help!
Our Team will meet with you and discuss the issues. We will investigate to include measuring and monitoring the sterile compounding facility’s large and small smoke pattern testing. Our comprehensive “OAR” report will include all gaps, with supporting pictures and video. A “corrective action” plan can be handed to the BOP or FDA to support your movement to continued compliance, and a “predictable” action plan to maintain continued compliance following repairs.
