Valtria, a company specializing in engineering and installation of clean rooms, has offered on October 22th at the Chamber of Commerce of Santiago de Chile, a technical talk under the title “Prevention of cross contamination in multiproduct facilities – New global concept”, together to its partners Qualipharma and Cenfotech.
In the technical talk offered by Alberto Carazo, expert consultant in the Pharmaceutical Industry of Valtria, the following topics were commented:
1. Procedure for the introduction of new products in a multi-product plant:
- ·What is the OEL?
- ·Different categorization systems (safebridge, Newmann, national systems …).
- ·Categorization of the plant (technical, organizational measures …).
- ·OEL adjusted / Recategorization according to the process.
- ·Expected concentration versus OEL.
- ·When to monitor and monitor health protocols.
- ·Practical cases.
2. Cleaning validations. Toxicological values and calculation of cleaning limits:
- ·New requirements at the cleaning validation level.
- ·Understand the relationship of toxicological values (PDE) and the calculation of cleaning limits.
- ·Comparison of traditional MACO limits, 10 ppm, 1/1000 therapeutic doses and new limits based on toxicological values.
- ·Definition of the worst case (product to sample and calculation limits).
- ·Practical and interactive examples of product calculation to be sampled and limits.
Alberto Carazo is an expert in the realization of pharmaceutical projects from the conceptual idea to Break-even, covering all phases of a pharmaceutical project: product definition, development and registration, conceptual design of the plant, definition of processes, implementation march, training, validation and qualification and compliance with regulatory requirements.