- Industry: Pharmaceutical Manufacturing
- Services: Owner’s Representative
The Challenge
This customer had recently commissioned a parenteral filling facility but had met with poor operations, confusing operator interface for DCS control, lack of scalability, poor batch controls, and major sterility issues. The poor design resulted in extended manufacturing cycles that reduced plant capacity and operability to unacceptably low levels. Although brand new, the plant needed a major overhaul to the Automation and Equipment Systems and they needed it in a hurry in order to meet scheduled production requirements.
The Solution
Our Subject Matter Experts worked with the manufacturing department to operate the facility for data gathering purposes. Information was obtained that enabled a Failure Mode Effects Analysis determining the root causes of the process and controls problems. The solution proposed by our team was to make several minor but critical equipment improvements and then to operate the plant to make sufficient product inventory to permit a brief shut down.
While this was happening, we led a team from all departments gaining consensus on the fundamental changes required for a successful manufacturing operation. We then developed Functional Specifications, participated in the selection of other team members, and managed the project through engineering and integration of the required modifications required to resolve the fundamental causes of the operability issues. Equipment and piping modifications were made and a new S88 compliant batch control system (software, existing hardware was utilized) was installed.
The timely construction completion, quick commissioning, and immediate operation objectives were met or exceeded and the customer was able to successfully use the facility for filling the new product for an international roll out.
The Result
The highly motivated engineering and integration team worked superbly together to produce a remarkable facility in record time ultimately leading to the timely and successful product launch.
