Parker domnick hunter employ a
combination of engineers & scientists with advanced degrees in the fields
of bioscience, biotechnology &
microbiology.
Using state-of-the-art equipment and facilities the Parker Laboratory Services Group are equiped to become a valued partner in your validation process.
Providing step-by-step validation
support to the customer by developing and executing process-specific protocols based on your application.
The Laboratory Services Group (LSG) at Parker domnick hunters provide
documented evidence provides a high degree of assurance that a specific
process will consistently produce a
product that meets its predetermined specifications and quality attributes.
Our LSG team are excellent
troubleshooters and play a vital role in maintaining product quality and integrity.
Quality control testing
- Water testing: TOC, endotoxin, bioburden, pH and conductivity
- Environmental monitoring, microbial assay
- Filter characteristics, visual bubble point, liquid and air flow rates, porometry analysis, water intrusion.
- Quality control testing of incoming filter materials including bacterial hallenge to ASTM 838-05 for sterilising grade products
- Lot release of finished products and rinse water/effluent analysis
Customer validations
- A bespoke service offering a full validation package to support sterile filtration steps
- Includes protocol and experimental design, technical support and production of an audit reference of each filter and filtered product
- Establish integrity test parameters
- Develop customer specific validation strategy
- Examination of filter extractables
- Documented assurance
Scientific research
- Microbial assays standard and bespoke
- Protein binding analysis via SDS PAGE and gel imagery
- Process simulation and scale up support
- New product design and optimisation
- Process characterisation and filtration analysis
