Working with a strategic partner, Cyton is able to provide assistance to manufacturers with cleaning validation, using our partner's analytical and microbiological expertise. This service can be particularly useful following the introduction of the EMA's Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.
Our partner's services in cleaning validation include:
- Overview of regulatory framework and requirements (Europe and US)
- Consulting and assistance for cleaning validation strategy and its implementation
- Organisation of the Steering Committee
- Writing of documents (Validation plans, protocols, reports..)
- Return on investment : optimisation of methods, grouping, worst-case, special products...
- Which contaminants should be monitored ?
- How to calculate acceptance thresholds ?
- Training of managers and operational teams and qualification of sample collecting staff
- Development and validation of sampling techniques
- Development, validation and transfer of analytical methods
- Microbiological analysis
- Physicochemical analysis : specific (HPLC, GC..) or non-specific methods (TOC..)
- Sample analyses
Analytical development and stability studies