Revamping of the Coating and Blister Area

Revamping of an area in a pharmaceutical company does not end with the mere physical relocation of the systems, but entails the involvement of numerous resources and a series of more demanding measures covering the entire area involved, mechanical/electrical parts, documentation and management applications.

The activities required by a revamping project therefore include a series of actions and checks aimed at testing correct operation after the changes, in compliance with current regulations (GMP and safety regulations).

The release of each area also depends on the successful outcome of all the activities envisaged and planned by the project and on authorisation by AIFA (Italian Drug Agency) For the activities envisaged by the Coating and Blister Area revamping projects, the Client wanted to rely on an external partner, with solid experience in the sector.

The Client requested the specific technical skills of the S4BT equipment, systems and utilities qualification team.

After a careful analysis and selection of possible partners, the client company chose S4BT, finding within it the essential professionalism and skills to achieve the established objective. The S4BT work team performed the following activities for the revamping of the Coating area:

• Drafting of the validation documentation (FRS/FS; IOQ, Validation report and traceability matrix)
• IOQ (drafting, compilation, test execution and final data collection) following the installation of tanks equipped with agitators, commissioning of portable tanks for the transfer of Coating to the drum mixer area and commissioning of tanks with micronisers.

The team was also directly involved in adapting the operation of the SCADA supervision and control system in the HVAC system to the regulations, with particular attention to alarms, interlocks, I/O signals, the graphic interface, hardware and software configurations, IP addresses, field communication protocols and field devices.

For the revamping of the Blister area, the S4BT Team worked on:

• Drafting of validation documentation and test execution
• Replacement and validation of a PLC in consideration of new I/O signals, alarms and relevant trends of the Pharma department HVAC systems
• Proper reactivation of the blister lines following a relocation, with particular attention to correct installation
• Functional revalidation of the dedicated HVACs in each blister sector and the HVAC installed in the secondary packaging area. The validation took into account the graphic synoptics, alarms and trends.
• Revalidation of the Data Matrix code (serialised two-dimensional barcodes on boxes) management software installed on the packaging lines to ensure product traceability.
• Revalidation of the Arlequin vision software system installed on the packaging lines, in order to ensure the main software functions and their integration with the packaging line following the changes.

This validation included general checks on the functioning of the machinery within the process (management of waste from non-compliant products and packaging, camera settings and functional check on PVC plates).

The S4BT consultants cooperated in synergy with various areas of the Client company, including Quality, Validation, Production and Engineering, for the entire duration of the project.