Services
Validation
Burke Herring, LLC provides Commissioning, Qualification, and Validation services to our bio/pharma client for projects of all sizes. From single pieces of equipment to entire facilities, we satisfy regulatory expectations for CQV. We team with our clients to provide rigorous protocols that assure efficiency, reduce risk, and maximize results.
Our services include:
-
URS Collaboration
-
Design Qualification
-
Factory / Site Acceptance Testing
-
Turn Over Packages
-
Standard Operating Procedures
-
Commissioning
-
Installation / Operational Qualification
-
Performance Qualification
-
Process Validation
-
Periodic Reviews
-
Requalification
Consulting
Burke Herring gives expert advice to your most difficult issues. We work with customers on a variety of topics, including EH&S, quality systems, and more.
Laboratory Field Testing
& Certification
Burke Herring offers the most reliable and comprehensive field testing and certification available. We adhere to the most current guidelines available and are pioneers for new methods.
Basic Field Guides in California
-
Fume Hood- CAL/OSHA T8s5154.1 and ASHRAE Standard 110-2016.
-
Clean Bench- IEST-RP-CC002.
-
Biological Safety Cabinet- CAL/OSHA T8s5154.2 and NSF-49-2014.
-
Terminal HEPA Filter- ISO14644-3 and IEST-RP-CC006.
-
In-line HEPA Filter- ISO14644-3 and IEST-RP-CC006.
-
Cleanroom- ISO14644-1,3 and IEST-RP-CC006.
Calibration
Burke Herring performs field calibration of incubators, freezers, cold rooms, and more.
Decontamination
Burke Herring performs large and small scale chemical decontaminations using hydrogen peroxide vapor.
We are available on-demand to perform these services so that your company has minimal downtime.
USP<797>/<800>
Burke Herring provides services in support of our pharmacy clients' ongoing needs for compliance with USP<797> and USP<800> requirements. Our staff includes CETA/CNBT-professionals, individually-certified for testing Sterile Compounding facilities. Count on Burke Herring, LLC to help maintain your facilities in top shape.
Our services include:
-
USP<797>/<800> Plan Development and Implementation
-
Cleanroom Certification per ISO14644 and CETA CAG
-
Equipment Certification and Calibration
-
Viable Particulate Sampling
-
Non-Viable Particulate Sampling
-
Room Pressure Differentials
-
Air Changes per Hour compliance
-
HEPA Filter Leak Tests
-
Ventilation Assessments
-
Pressure Gauge Supply, Installation, and Calibration
-
Temperature Mapping of Refrigerators and Drug Storage
-
Airflow Visualization Studies (Video)
Repairs
We pride ourselves on the quality of our repairs and can fix any issue with a HEPA filtered device, like biological safety cabinets, clean benches, and similar hoods. Our superior troubleshooting expertise allows us to repair your hood within two service visits: one for troubleshooting and one for repair. This saves you time and money on expensive and unnecessary repairs due to inaccurate initial diagnoses made by inexperienced technicians.
We work with our customers to create a preventive maintenance schedule that best suits their needs. Most of our customers see well over 10 years of service life on their HEPA filters and are informed of the expected remaining service life based on the certification data. We also stock a wide range of HEPA filters so you can expect your hood to be repaired in a timely manner.
