Sterile Cleanroom Certifications – Above and Beyond USP 797 Requirements

Our accreditations place us in the top 1% of compounding pharmacies

Cleanroom Certification

We go above and beyond the USP 797 requirements

We are required by the NJ and our accreditation organization to have a company come in and certify our cleanrooms twice yearly.

In addition to what is required, we also contract our own independent CETA (controlled environment testing association) professional to do additional surface and active air sampling more often than is required. We also perform additional fingertip testing of personnel beyond the minimum requirement of USP 797.

Read More: Remote Monitoring Solutions for Laboratory and Pharmaceutical Operations

 

Wireless monitoring systems throughout the pharmacy

We have installed wireless sensors from Monnit® not only our sterile suite of rooms, but also in our entire facility

 

Wireless sensors continuously monitor such things as:
  • Temperature of all rooms, refrigerators, freezers and incubators
  • Humidity levels of all rooms
  • Pressure differential between our different ISO classified cleanrooms
  • Pressure differential between our USP 800 non sterile compounding lab and our USP 795 compounding lab
 

In addition to what is required, we also:

  • Conduct additional surface testing
  • Perform additional fingertip testing
  • Have Monnit(R) wireless monitoring system
  • Sensors throughout the entire facility monitor temperature of rooms, incubators, freezers, refrigerators humidity levels pressure differentials between all cleanrooms and labs

We have expanded and are now in our state-of-the-art compounding facility in Ramsey, NJ shipping to multiple states.

Town & Country Compounding has been inspected by the New Jersey State Board of Pharmacy and National Association of Boards of Pharmacy (NABP) in addition to accreditation inspections. We are also accredited by ACHC for sterile compounding, non-sterile compounding, nursing and home infusion.