Expertise
Sterile & Aseptic Operations
Sterile operations leave the least room for interpretation. We support aseptic manufacturers with contamination control strategy, qualification of critical operations and the behavioral discipline that determines whether a cleanroom performs as designed.
Sterile and aseptic support
- Contamination control strategy development and assessment
- Aseptic process simulation (media fill) design, execution oversight and investigation
- Environmental and personnel monitoring program design and data trending
- Cleanroom classification, qualification and requalification
- Gowning qualification, aseptic technique observation and behavioral training
- Sterilization and depyrogenation validation, including terminal sterilization
- Sterility assurance investigations and non-sterility risk assessments
- Isolator and RABS operational compliance
Investigations under pressure
A positive sterility result, a media fill failure or an excursion in a Grade A environment demands a fast, technically credible investigation. We can provide experienced support to lead or independently review these investigations and the risk assessment supporting product disposition.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.