How to validate a new lyophilizer SCADA supervision and its connection to the network

Lyophilizers are used in pharmaceutical industry to dry heat sensitive products. This is a large and expensive equipment that is not easily replaced. It is then useful to upgrade some parts of the equipment as its SCADA supervision and connect it to the critical network of the company. The validation strategy will follow the V-cycle approach.

A lyophilizer is used when a pharmaceutical drug needs to be dried for different reasons as an increased stability (shelf life). The principle is based on water sublimation by decreasing the pressure inside the chamber, the boiling temperature is then lower than in normal conditions (atmospheric pressure and ambient temperature). This method is very useful for heat sensitive pharmaceuticals products. As this equipment is large and expensive, it is not easily replaced. After some time, it is sometimes useful to upgrade some parts of the system to comply with new regulations rules for example. If it has not been done previously, it is useful to connect the lyophilizer to the network to store and make the raw data and the batch reports available for every needed person. The purpose of this document is to present the validation strategy for a lyophilizer SCADA supervision upgrade and its connection to the network. (…)

1 INTRODUCTION
2 VALIDATIONSTRATEGY
3 INSTALLATIONQUALIFICATION
4 OPERATIONALQUALIFICATION
5 CONCLUSION
6 AUTHOR


This white paper has been created by Sébastien, Validation Engineer at Nalys