2019 Updates to USP <797> and how TSS is responding

August 20, 2019

Sampler and Media

By: Kyle Mulder, Associate Training and Technical Manager

USP <797> lays the foundation of standards for compounding sterile preparations. According to USP, “…<797> helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. It describes several requirements, including responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations.”*  In June 2019, USP rolled out its first changes to USP <797> in over a decade, addressing requirements related to administering, facility design, beyond-use dates, personnel training, and monitoring frequencies.  One of the more notable changes is the frequency of surface sampling changing from ‘periodically’ to monthly. The change to monthly surface sampling is intended to provide an additional measure of control and monitoring in between viable air monitoring and certification requirements every 6 months.

TSS recognizes how impactful the USP <797> changes are to its client base and is now offering a slew of services to ensure customers are compliant with the new regulations, which take effect December 1, 2019.

  • Viable Environmental Sampling SOP
    • Designed for customer use as procedural guidelines for their staff performing these services
  • Instructional Video and Tutorial Package
    • TSS will provide access to our online learning management system which contains training modules for a variety of pertinent topics.
  • Onsite Training with TSS
    • Topics selected by customer & offered to an unlimited number of employees
  • Surface Viable Sampling Kit
    • Includes sampling media, packaging materials, shipping container, ice packs, sample labels, chain of custody form, and shipping label to the lab
    • Media types can include TSA, SDA, or MEA
  • Airborne Viable Sampling Kit
    • Includes sampling media, packaging materials, shipping container, ice packs, sample labels, chain of custody form, and shipping label to the lab
    • Media types can include TSA, SDA, or MEA
    • Air sampling equipment is NOT included but we have an alternate product to suit your needs
  • Gowning Qualification Kit
    • Includes sampling media, packaging materials, shipping container, ice packs, sample labels, chain of custody form, and shipping label to the lab
    • Media type is TSA
  • Semi-Annual Fingertip Testing Kit
    • Includes sampling media, packaging materials, shipping container, ice packs, sample labels, chain of custody form, and shipping label to the lab
    • Media type is TSA
  • Semi-Annual Media Fill/Aseptic Technique Kit
    • Includes sampling media, packaging materials, shipping container, ice packs, sample labels, chain of custody form, and shipping label to the lab
    • Media type is TSA broth

For additional details on these services, please contact our team of experts via email at info@techsafety.com or by phone at 800-877-7742.  We look forward to working with you and your team to ensure compliance with the updated USP <797> regulations.  


* https://www.usp.org/compounding
 

Return to Blog