Reference Projects

Cases

Case 1: Set-up of a Team for Qualification and Commissioning for a big fill and finish plant.

The project team consists of our current ScieTec engineers. The project lasted for 2,5 years, during which our team delivered management functions as well as documentation tasks.

a. Commissioning and Qualification (constructions site and documentation)
b. Matrix: Team Leader and Execution Staff

Case 2: Concept design of an existing isolator for a new process.

ScieTec provided a team of two engineers who developed the concept design. Reason for the project was that our customer wanted to change an existing isolator with regards to a new product. For this, the process needed re-definition and a supplier who coordinated the modification.

a. Planning of the isolator and definition of a new process
b. Modification of the existing plant

Case 3: Project coordination and trouble shooting for a big project

A ScieTec project manager takes on the role as mediator and project coordinator with the aim to finish the last 20% of a project. For achieving this, our project manager visualises the responsibilities and communication paths, balances the interests of the stakeholders and finds reasonable compromises for the benefit of the project results.

a. Mediator – Interfacing between several stakeholders
b. Setting up a communication matrix

Case 4: Examination of certain steps of an existing process of a notable pharma company

Checking whether or not the process is still compliant to the most recent qualification requirements and guidelines. Simultaneously, the process equipment should have been evaluated with regards to the utilised EQPs being still compliant. For a possibly necessary modification of the plant, the total Investment Cost (TIC) was calculated and a resilient schedule was set-up. As such, the results were presented to the management for approval.

a. Evaluation of processes and check of the documentation
b. TIC-calculation
c. Scheduling

Case 5: In a vaccine production plant the commissioning and qualification activities were to be structured and accelerated

For this, ScieTec has taken on the coordination of the commissioning and qualification and implemented new communication channels for all project stakeholders. The process for the commissioning and qualification was – upon approval of the customer – optimised and the execution duration was shortened. Resource-constraints were met and solved by ScieTec’s short-term assignment of qualified personnel.

a. Commission and Qualification (documentation-based)
b. Communication Matrix
c. Scheduling

Case 6: A capacity increase in clean utilities and an exchange of equipment

needed to be executed. For this, the ScieTec team on-site established a new concept with the operator and transferred this concept to a resilient plan and consequently into execution. After the re-qualification, the plant could be activated in-time for production.

a. Site inspection
b. Concept design study
c. Re-qualification (Documentation)