USP <797> with MicroSEQ Temperature & Humidity Monitoring

Avista Pharma Solutions works with you to identify your USP <797> environmental monitoring with MicroSEQ microbial identification and other testing needs based on the use of your cleanrooms and critical utilities, the intended use of the products being manufactured and the existing resources in place. Current regulatory requirements specify that monitoring programs be established based on risk.

 

Routine Environmental Monitoring

Avista Pharma Solutions offers a total support service, which provides trained and gowning qualified analysts with scientific degrees, calibrated equipment, and quality control tested media, validated incubation methods, validated transportation of samples, analysis and reporting.

 

As an alternative to our full service offering, we have programs which provide trained staffing to supplement your existing program for environmental monitoring during start-ups or qualification activities. Our analyst can provide a number of environmental services, including USP <797> services, microbial identification through MicroSEQ (rapid 16S rDNA sequencing) and Vitek® (MALDI-TOF), or even temperature and humidity monitoring. In addition, we can provide quality control tested media for your use with a courier pick up upon request to ensure samples are put on test within 24 hours to minimize potential impact on recovery of organisms. Samples will be incubated within our validated chambers and analyzed by our trained Microbiologists.

 

Full Range of Environmental Monitoring Services

Avista Pharma provides a full range of best-in-class Environmental Monitoring Services:

 

  • Active Viable Air Monitoring
  • Passive Air Monitoring
  • Viable Surface Monitoring – Contact Plates or Swab Methods
  • Anaerobic Monitoring
  • Absence of Specified Microorganisms USP/EP
  • Total Air Particulate Monitoring
  • USP <797> Specific Incubation Conditions
  • USP <797> Gloved Finger-Tip Analysis
  • Personnel Monitoring
  • Personnel Support
  • In-Process Monitoring
  • Temperature and Humidity Monitoring
  • Pressure Differential Monitoring
  • Water Sample Collection for Laboratory Analysis
  • Data Analysis and Trending Services
  • Incubation, Analysis, and Reporting
  • Isolate Characterization and Identification via MicroSeq or MALDI-TOF