We have a long track record in providing process engineering
design and validation services to clients in the pharmaceutical,
chemical, food, dairy and beverage industries.
Purified water systemWe are skilled in
undertaking front-end studies where required to define precise
requirements, agree layouts and prepare and project budget and
programme. We also specialise in testing and commissioning plant,
instrumentation and control systems.
Having our own validation specialists means we can prepare
validation masterplans in house, smoothing the process of
specifying and assembling all necessary documentation and
certificates to facilitate validation of the completed
installation.
Projects undertaken over the years have involved milk and food
process installations, brewing and distillation, biotechnology
fermentation and purification, batch and continuous reactors, bulk
chemical storage and distribution and CIP and SIP systems.
Our process design services cover:
- Outline and detailed process designs
- P&IDs and flow schematics
- Detailed process descriptions for automation
- Plant and equipment layouts
- Performance specifications
- Equipment sourcing and procurement
Schering Plough-Avondale's pharmaceutical service
distribution plantWe offer the added ad-vantage of a highly
qual-ified and experienced specialist capability in current Good
Manufacturing Practice (cGMP) compliance and validation. This
enables us to offer a comprehensive range of services from
consultancy and training through to full respon-sibility for total
facility validation.
Our validation services encompass:
- CGMP philosophy and validation masterplans
- Gap analyses and impact assessments
- Retrospective and prospective validation
- Protocols and procedures
- Cleaning/sanitation validation protocols
- 21 CFR Part 11 computer system validation
- Regulatory compliance consultancy
- Change control procedures
