Protect people, the environment and product quality

Risk-based cleaning validation, taking into account the PDE concept and product and system bracketing, guarantees the effectiveness and reproducibility of the cleaning process and keeps the cost of even complex approaches within limits.

Cleaning in the pharmaceutical environment, especially in manufacturing of medicinal products and medical devices, requires a high level of chemical, pharmacological, and process knowledge. The type, quantity, and source of possible contaminations as well as cross-contaminations influence the reproducibility of the cleaning process. In pharmaceutical production, and especially in multipurpose facilities, cleaning procedures must be validated according to national and international regulations.

Risk assessment based on toxicological findings and PDE values

In the European Union, a paradigm shift was initiated in 2015 by a new directive of the European Medicines Agency (EMA). The tolerable limits must be set based on a toxicologically justified risk assessment. The maximum daily exposure of a patient ("permitted daily exposure", PDE values) must be calculated based on toxicological data and is a binding limit of contaminants in the derived product. The leading document for the execution of cleaning validation in Europe is the EU GMP Guideline (Chapters 3 and 5 as well as Annex 15). Cleaning validation requires a risk-based approach.

Valicare offers you a detailed basic training including regulatory requirements for cleaning validation as an introduction to this complex topic. In addition, our experienced teams advise and support you in planning and implementing validation as well as GMP-compliant documentation. One of Valicare's core competencies lies in performing product and plant bracketing to simplify and reduce the required effort. Our scope of services is completed by developing and establishing GMP-compliant cleaning methods and applying cleaning validation also in the field of medical devices.