Installation of new Hot Melt Extrusion (HME) technology in Pharmaceutical plant

Managing the specification, installation and verification of an emerging processing technology for a pharmaceutical manufacturer

 

Introducing the latest technology HME for drug production

The customer, subsidiary of a Dublin based pharmaceutical firm employing around 300 staff at their Dublin facility, produced some high-profile tablets that are supplied to the global markets. The company was introducing a new emerging technology for processing in the pharmaceutical industry. Over the last decade hot-melt extrusion (HME) has emerged as a powerful processing technology for drug delivery. HME is regarded as an efficient technique in developing solid molecular dispersions and has been demonstrated to provide sustained, modified and targeted drug delivery resulting in improved bioavailability. 

 

The process consisted of mixing ingredients through granulation blend by separating ingredients. The process is called Hot Melt Extrusion (HME) and involves heating the ingredients until they melt and then mixing them together and cooling so they stick together in a powdered form to make tablets.

 

Managing delivery of a key capital project

Malone Group was engaged by the customer to support the introduction of the HME process to this plant. The team developed the User Requirements Specification (URS) for this key capital project in collaboration with the customer. The specification covered everything from the room that would house the equipment to the equipment itself. The team were required to support the customer through capital approval, procurement and Factory Acceptance Testing (FAT), delivery, installation, commissioning and qualification. This included training of operators, establishing the technical and maintenance requirements, documenting all aspects of managing and operating the system and calibrating the installed system.

 

The product qualification was not included in the scope of the project by the customer. Due to the space constraints of the existing site and the requirements of the new production process, the project team had to restructure how space was used within the facility and move some plant facilities to create the space needed.

 

On time delivery to support new product development

This new technology development would enable and support new product introduction for the customer. This installation of the HME technology was a €3.5 million pound project which was successfully designed and delivered over a 15 month period.

Pharmaceutical