Project
Supporting our client in the implementation of the strategy and the validation process of the cleaning processes for a biotechnological bulk production unit.
- General methodology
- Analysis of US and European standards
- Implementation of a strategy for rational validation with maximum return on investment (optimisation of methods, groupings, “worst cases”, special products, etc.): presentation of typical matrices
- Accompaniment on the follow-up of the maintenance in validated state
Challenges
- Quality : 5/5
- Cost : 4/5
- Deadlines : 3/5
- Security : 3/5
Services provided
- Definition of the strategy and organisation of the steering of the validation;
- Contaminants and tracers to look for
- Calculation of acceptance limits according to the PDE approach
- Sampling methods
- Sampling plans
- Analytical methods coupled with sampling
- Writing :
- Master Validation Plan
- Protocols/VN reports
- Performance of the tests
Summary
Bulk building 1200 m²
