Customized access control system based on established flows of personnel within a production site
Need
According to the regulations of the Ministry of Health, AIFA and FDA, companies have the obligation to ensure non-contamination between the production areas of β-lactam antibiotics and non-β-lactam antibiotics. For this reason, IBI has divided the internal and external areas of the plant according to the production carried out and has placed turnstiles and barriers at points of access between areas with the aim of verifying all flow of movement of personnel within the plant and preventing staff and guests currently in one area from accessing the other.
Target objective
Avoid cross contamination between β-lactam antibiotic and non-β-lactam antibiotic production areas.
Solution
We developed and provided IBI with a solution consisting of:
- a web application for the management of internal staff and guest registries, which provides the possibility of visualizing and reconstructing the flow of movement of a specific person in a specific day;
- an anomaly management system, which sends a report based on established rules for the flows;
- field devices that handles access requests when a user identifies himself by badge and send them to a central flow analysis engine (complex event processor) that responds by either allowing or denying access.
The solution has been validated according to FDA CFR21.
Extra benefits
The possibility of obtaining a real time report of the presence of personnel and their position at a precise moment, also useful in case of emergencies.
Methodology/Technology
Web application (master data management, access log, anomaly report, attendance report); complex event processor; hardware devices; IoT.
- Customer:
- IBI - Italian Biochemical Institute Giovanni Lorenzini S.p.a.
- Website:
- https://www.ibi-lorenzini.it/it/
- Sector:
- pharma (and third-party manufacturing)
- Department/Process Affected:
- manufacturing/production control
- Service Offered:
- contract software development
- Development Period:
- 2014/2015
- Software type:
- Customized access control system based on established flow rules
