Service
Commissioning and qualification
We commission and qualify pharmaceutical equipment and systems, from factory acceptance testing to performance qualification.
We provide commissioning and qualification for pharmaceutical manufacturing equipment and systems, aligned to ASTM E2500 and ISPE GAMP 5.
Our directors have qualified filling lines, SKAN and B+S isolators, freeze dryers, sterilisation tunnels, autoclaves and clean utilities across multiple global sites.
What we deliver
- Factory and site acceptance testing
- Installation, operational and performance qualification protocols
- Risk based qualification strategy
- SKAN isolator qualification
- Hydrogen peroxide decontamination cycle development
- Clean utility qualification
- Automation and control system qualification
- Qualification summary reports
At handover
What you receive
- Risk based qualification strategy
- Executed factory and site acceptance tests
- Approved installation, operational and performance qualification protocols and reports
- Qualification summary report for each system
Related services
Operational readiness
Structured readiness programmes that prepare people, processes, systems and documentation for routine GMP operation from day one.
View serviceQuality and complianceProcess performance qualification and media fill
Strategy, protocols, execution support and recovery for process performance qualification and media fill campaigns.
View serviceQuality and complianceComputer system validation and data integrity
Validation of automation, laboratory and quality systems to ISPE GAMP 5 with ALCOA+ data integrity controls.
View serviceDiscuss your project with an engineer
Tell us the scope, the site and the timing. A director will reply within one business day.