IV rooms, often used in hospital and pharmacy applications, are a place for the sterile preparation of IV medications.
Under the revised USP <797> regulations, compounded sterile preparations (CSPs) are requiring stricter adherence to federal regulations and protocols.
Maintaining strict adherence to FDA regulations and other governing institutions is important to pharmacists and all compounding personnel in:
- Healthcare institutions
- Physician practice facilities
- Other facilities in which CSPs are prepared, stored, and dispensed
The challenge with compounded preparations is ensuring that the solutions or drugs to be administered are made in sterile conditions that conform to current Good Manufacturing Practices (cGMP's). This requires the utilization of specific equipment and protocol including specialized air filtration, properly garmented workers and regimented QC testing. Aside from the equipment and validation processes, one must also stay familiar with current regulations and standards.
It is essential that newly constructed clean rooms and enclosures maintain a strict adherence to these and other requirements through in-depth knowledge and an understanding of current regulations and protocols, as well as the ability to provide the level of certification required for a particular application.
A Turn-Key Cleanroom Solution
PortaFab specializes in the turn-key design and construction of modular clean rooms including applications specifically requiring IV rooms and enclosures. We will be happy to provide a customized quote based on your specific requirements and application. Please fill out our Request a Quote form in order to get the process started.
Read more about USP 797 cleanrooms and compounding labs.