Batch Monitoring and Review System for Intersurgical

When Intersurgical built a new sterilisation plant an automatic monitoring and batch review system was required to record critical process parameters for each sterilisation batch and to enable automated batch release based on a review of those parameters. In addition it was required to integrate the monitoring system with the existing EFACS ERP system to provide facilities for batch make up and product tracking.

IJ Controls were selected to analyse the requirement and implement a suitable solution. The system supplied provides a simple, quick and effective means of reviewing process parameters for batch release which is much quicker than the traditional method of analysing chart recorder traces.

A Certificate of Sterility is generated for each completed batch and stored in a database for retrieval and display as required. More recently an electronic signature capability has been added to the system. As a result the entire operation is paper-free whilst complying with the stringent requirements of 21 CFR part 11

Interface with the EFACS ERP system now provides an automated batch make up process which selects warehouse stock so as to optimise the contents of each sterilisation batch, and significantly reduces the time required to create batches for sterilisation.