FILL FINISH
Technology

We at Fill Finish Technology suggest that purchasing a new piece of equipment can be better described as purchasing a ‘new’ process. As well as the equipment element itself a process will also include inputs and outputs (for example) material flows, personnel flows, work methods and environmental considerations. We work with companies to develop and outline their manufacturing process to ensure they purchase the equipment that meets their requirements.

GMP (Good Manufacturing Practises) is a system of regulations to ensure drug (medicinal) products are consistently produced and controlled according to quality standards. The US FDA code of federal regulations for pharmaceutical and drug manufacturers appear under the Title 21 section. The EU EMA regulations for good manufacturing practises fall under EudraLex – Volume 4: One of the key annexes (Annex 1 - manufacture of sterile medicinal products) is due for revision and release in 2022. Equipment vendors therefore must ensure their equipment can support the manufacture of medicinal products to meet these regulations.

This task is undertaken as a process of stages, which are typically as follows: Concept Design Stage: where the requirements are agreed, typically in the form of a User Requirement Specification (URS). Procurement: commercial activities leading to the purchase of the equipment from the vendor. Detailed Design: this covers the mechanical, electrical and control system elements. Design is delivered and agreed via engineering drawings and design specification documents including the Functional Design Specification (FDS), Hardware Design Specification (HDS) and Software Design Specification (SDS). Machine Build: the vendor will build the machine under their quality system and perform internal testing. Factory Acceptance Testing (FAT): customer testing carried out at vendor facility. Installation: Activities associated with the shipping to customer site, installation of equipment and services and commissioning activities. Site Acceptance Testing (SAT): Equipment testing carried out at customer site. Qualification and Validation: GMP testing activities to qualify the equipment and validate the manufacturing process. Operational Readiness: Ramp up activity to integrate the equipment into the customer manufacturing system, key elements include training, documentation, and operational support. Commercial Production: Manufacture of safe medicinal and drug product.