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Design, Build and Verification of Pharmaceutical Stability Testing Laboratory

Establishing a new stability testing facility for an Irish based specialist pharmaceutical manufacturer

A managed service for capital project delivery:

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 had an internal project management function within the business that managed the group’s strategic capital projects of value above €10m. For capital projects under this value, the company setup a managed service with Malone Group to manage all of these projects.

Shifting stability testing capability from the US to Ireland:

Malone Group performs the role of Client Representative on capital projects providing project management, feasibility assessment/costing, design and validation including health and safety management.

In this role the Malone Group team use the customers internal systems and processes to deliver a range of projects from office moves with IT fit-outs to the construction and installation of a laboratory. In this particular project the customer was keen to setup a stability testing facility in the Irish site. This critical service, previously provided by a US based operation, involves testing ingredients and the finished product in a range of environments to determine the working shelf life.

The laboratory size had to fit within the existing facilities and house 4 chambers that could accelerate aging of production samples from batches. The facility also included a weigh room and instrument laboratory which analysed ingredients.

The Malone Group team managed the entire project from seeking capital approval, to scope design, costing, installation and managing funds to the final validation stage of the project.

Fast-tracked delivery of a new facility within budget:

The entire project was delivered within a 6 month timeframe on plan and within budget. Our team using their extensive knowledge and experience was able to advise the customer on alternative scenarios to keep the cost under control, using the knowledge and experience of the team.