Cleaning procedures and the associated validation ensure safety for product, personnel and the environment and require a risked-based approach.
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 have to be validated according to national as well as international regulations.
In the European Union, a paradigm shift was initiated in 2015 by a new directive of the "European Medical Agency". The tolerable limits have to be set based on a toxicologically justified risk assessment following the guideline. The maximum daily exposure of a patient ("permitted daily exposure", PDE values) has to be calculated based on toxicological data and has to be used as 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). A risk-based approach has to be applied for cleaning validation.
Valicare GmbH offers you a detailed basic training including the regulatory requirements for cleaning validation as an introduction to this complex field. In addition, our industry-experienced teams advise and support our customers in the planning and implementation of validation as well as GMP-compliant documentation. A special core competence of Valicare GmbH lies in performing of product and plant bracketing to simplify and reduce the required effort. The development and establishment of GMP-compliant cleaning methods and the application of cleaning validation also in the field of medical devices complete the scope of services in this field.