Environmental Qualification Support

Avista Pharma Solutions has been successfully contributing to the qualification of new facilities, expansion of facilities and facility renovations for over five years. Our experienced staff brings over 10 years of quality, validation, and contamination control experience to provide superior services during the execution of facility and critical utility qualifications.

 

Facility Qualification Support

We have worked with companies small and large to execute projects meeting the quality expectations and timelines of our clients and their regulators. Avista Pharma can collaborate with your internal validation teams, consultants and quality units to create, execute, and/or support your qualification projects. Our full range of Cleanroom Testing Services is utilized in support of facility and critical utility qualifications.

 

Avista Pharma has the full support of in-house Analytical and Microbiology Laboratories to further support equipment cleaning studies, sterilization studies, and disinfectant studies. Please contact us for information regarding qualification support, including environmental qualification, water system qualification, and disinfectant qualification.

 

Facility Qualification Service Offerings

Our qualification service offerings include:

 

  • Risk-Based Qualification Protocol Planning and Development
  • Environmental Qualification
  • Cleanroom Certification
  • In-Situ Cleaning Studies
  • Microbial Identification Services
  • Cryopreservation of Environmental Isolates
  • Disinfectant Qualification Studies
  • Project Management Support
  • As Built, At Rest, and Operational Qualification Activities
  • Maximum Occupancy Studies
  • Room Recovery Studies
  • HVAC Shut Down Studies
  • Water System Qualification
  • Equipment Cleaning Study Support