Infusion solution company Widatra Bhakti’s existing production capacity was too small to cover all its market needs. Having worked successfully with NNE Pharmaplan for over 20 years, the company now needed a combination of engineering and consulting support to implement an extension.

Mid-project regulatory change requires creative approach
Working together, Widatra Bhakti and the NNE Pharmaplan team agreed on a solution for the design and delivery of the main process equipment on a turnkey basis.

For the qualification and validation of the new extension, the team provided consulting support to help the company help itself. In two workshops and based on the validation master plan prepared by NNE Pharmaplan, Widatra Bhakti’s staff was trained in the preparation and execution of the necessary documents and plans.

A challenge during the project execution was a changed authority requirement for the sterilisation process at the end of the engineering phase. The NNE Pharmaplan team supported the company in finding a technical solution to address this issue while taking into consideration the company’s product needs.

A strong relationship over time
With a relationship going back to the original facility built in 1984, there was a great deal of team spirit and good communication across the whole project team.

The new extension passed its authority inspection in June 2007. Due to the fast and successful project execution, Widatra Bhakti has planned to extend its facility with a new line in 2008 – and will once again call on NNE Pharmaplan for support.