Reference projects

Cases

Below you will find an excerpt from our reference projects for a first impression.

Case 1: Assembling a Qualification & Commissioning team for a large Fill&Finish plant.

The project team consists primarily of current ScieTec engineers. The project lasted approximately 2.5 years, with our engineers taking over team leadership and documentation.

a. Commissioning and qualification (construction site and documents)
b. Matrix – Team Lead and Employees

Case 2: Designing an existing isolator for a new process.

ScieTec provided a team of two engineers to handle the redesign. The client wanted to convert an existing isolator for the site to accommodate a new product. The process was redefined and the service provider for the conversion was coordinated.

a. Planning isolator and new process definition
b. Conversion of an existing facility

Case 3: Taking over the project coordination task and troubleshooting for a large project.

A ScieTec project manager acts as a mediator and project coordinator in a large-scale project to ensure the final steps of the project are completed. They clarify responsibilities and communication channels, balance stakeholder interests, and find compromises that benefit the project's progress.

a. Mediator – interface between several actors
b. Communication channels / matrix

Case 4: In a well-known pharmaceutical company, individual process steps of an existing process are to be reviewed,

whether they were still valid within the framework of the latest qualification regulations. At the same time, the process equipment was to be inspected to determine whether the EQPs used still corresponded to the state of the art. For any necessary modification or upgrade of the plant, the total investment costs (TIC) were determined and a reliable schedule was created. This plan could then be presented to management for approval.

a. Review of processes and documents
b. TIC creation
c. Schedule / Scheduling

Case 5: In a vaccine production facility, the commissioning and qualification activities are to be restructured and thus accelerated.

To this end, ScieTec took over the coordination of commissioning and qualification and implemented new communication channels for all project participants. At the same time, the commissioning and qualification process was optimized in collaboration with the customer, thus shortening the execution time. ScieTec was able to overcome resource bottlenecks by deploying its own qualified staff.

a. Commissioning (IBN) and qualification (document-based)
b. Communication matrix
c. Appointment and scheduling

Case 6: An increase in capacity in a pure media supply and the replacement of equipment

The necessary steps for autoclavable cleaning must be performed. To this end, the ScieTec on-site team works with the operator to develop a concept, translate this into a robust plan, and implement it. After requalification, the system was able to return to production on time.

a. Inspection of the facility
b. Concept study
c. Requalification (documentation)