Engineering

FILL/FINISH SYSTEMS

Support with equipment systems, these include formulation; aseptic filling and isolator systems; lyophilization; cleaning and sterilisation systems through to clean utility systems.

Case Study: Aseptic Fill M/C Installation & CQV Support

Team Horizon partnered with our client in Athlone to design and build a cleanroom (Grade C – ISO 7), install a nested vial filling machine (with an ISO 5 isolator environment and VHP technology) and co-ordinate the overall CQV activities for the equipment and facility. This was the first project that our client had undertaken to deliver an ASTM E2500 ‘risk based’ approach to validation. Team Horizon helped develop and implement the validation strategy.

INSPECTION & PACKAGING SYSTEMS

Support with equipment systems, these include for both product, container & packaging inspection systems, including serialisation or track and trace systems.

Case Study: International Serialisation Feed Study

Team Horizon partnered with our client to carry out an international Front End & Engineering Design (FEED) Study to determine how serialisation could be successfully integrated across the vaccines group. This study spanned 10 countries across 35 packaging lines. The challenge was to determine a baseline or AsIs ‘current state’ analysis of the existing manufacturing systems. After which the next stage was to develop a scalable technical solution outlining the ToBe ‘future state’ analysis. The study was required to be implemented across the complete vaccines group; this included locations in the US, Belgium and Canada.

GMP BUILT ENVIRONMENT

Support with key activities, these include process architecture and equipment installation; concept design through to CQV support.

Case Study: Green Field Pharma Start-up

Team Horizon worked as part of an extended engineering partnership (A&E) to deliver a basis of design for a new sterile ophthalmic pharmaceutical facility in the midlands. The team focused on the process development and equipment lifecycle activities to enable a commercial operation from bulk manufacture, through to filling and packaging. In addition, Horizon outlined the CQV strategy and proposed an agile method of implementation to support a compressed programme schedule to achieve EU (& FDA approved) commercial manufacturing of drug product.

Visit www.fillfinish.com to find out more about how we can support you with your pharmaceutical manufacturing needs.