Paul Temoche

IMA Active Area & Product Manager.

Paul has more than 15 years experience in the Pharmaceutical Processing, Powder Handling & Washing fields. Since early years was dedicated to projects and new developments in the solid dose field from Zanchetta Italy. During the last years, he was directly involved in many projects and equipment design for high containment solid dose plants worldwide.

Paul holds a Ph D degree in Chemical Engineering and he is currently based in IMA Italy headquarters.

Abstract of speech

Powder Transferring Control in High Potent Solid Dose Pharmaceutical Plants Case Study: a complete solid dose production plant Flexibility is a prime requirement for pharmaceutical industry, and demand is growing for multiproduct/multipurpose installations. At the same time modern API are getting more potent and regulatory more stringent.

This resulted to the increasing active toxicity (less quantity, higher potency), increasing regulatory concerns over process and handling product containment, increasing importance of avoiding cross-contamination by product protection for reducing the risk of product contamination from outside contaminants and, consequently, reducing the risk of operators contamination by protection against active substances. Besides, the external environment protection for reducing the risk of pollution. Therefore, robust and perfectly contained production systems are needed and these should be based on GMP designed equipment and risk-based approach to facility, process and installation design.

The case study shows how customer requirements in terms of facility designation, plant concept, and process flow, can be transformed into a complete pharmaceutical department for the processing of Highly Active Pharmaceutical Ingredients.