Service
Process engineering
We design, optimise and scale up processes for sterile fill finish and biotechnology manufacturing.
Our process engineering work is led by a director with more than 20 years of hands on experience in aseptic fill finish, lyophilisation and sterile manufacturing.
We work through process problems on the line with your operators and quality team, then document the solution so it holds up in a regulatory inspection.
What we deliver
- Process design and optimisation
- Equipment selection and specification
- Process risk assessment using failure mode and effects analysis
- Filling recipe development
- Lyophilisation cycle development
- Process validation strategy
- Technology transfer protocols
- Overall equipment effectiveness analysis and improvement
At handover
What you receive
- Process risk assessment using failure mode and effects analysis
- Process and equipment specifications
- Filling recipes or lyophilisation cycles ready for qualification
- Process validation strategy
- Process knowledge documented for transfer between sites
Related services
Commissioning and qualification
Risk based commissioning and qualification for filling lines, isolators, freeze dryers, sterilisation and clean utilities.
View serviceOperationsTechnology transfer
Structured transfer programmes for new product introductions, site transfers and scale up to commercial manufacturing.
View serviceOperationsOperational readiness
Structured readiness programmes that prepare people, processes, systems and documentation for routine GMP operation from day one.
View serviceDiscuss your project with an engineer
Tell us the scope, the site and the timing. A director will reply within one business day.