References
Below we present a selection of our references.
These demonstrate how we plan, manage, and successfully implement projects.
Integration of an air dryer into an HVAC system
Project Overview:
An RS-Biopharma client is a leading international contract manufacturing
company and faced the challenge of upgrading its production facility within six months to manufacture under very dry air conditions in cleanrooms.
RS-Biopharma was commissioned to manage the complete project for this
facility upgrade.
How RS-Biopharma solved the problem:
Due to the very tight timeframe, we proposed a pragmatic project
implementation plan that relied partly on leased equipment and employed a change-based approach, avoiding the complexity of extensive qualification.
According to ISPE guidelines, full qualification is not required if a system is
designed and installed in such a way that it does not directly affect product
quality. Based on this, a risk-based approach was implemented.
RS-Biopharma undertook the creation of all quality-related documentation
(including GMP and change documentation) and procured an air dryer from a qualified premium supplier. This supplier provided comprehensive support for the project in conducting and documenting FAT and SAT activities, ensuring seamless integration into the existing HVAC system.
Results:
By organizing comprehensive project management and GMP documentation, and by integrating all participating suppliers into the project requirements, we were able to save valuable time. The production facility was released for
regulated operation on schedule. The project was successfully completed and
recognized as a team effort by all involved.
Removal of volatile organic compounds (VOCs) from the exhaust air of a production plant
Project Overview:
An RS-Biopharma client is a leading global life science company. The company's production processes utilize organic solvents which are emitted in the exhaust air from the production plant.
As part of the environmental permit renewal process, a significant reduction in these emissions was required. The company commissioned RS-Biopharma to define a suitable strategy, identify appropriate technical solutions, and select the appropriate supplier for the necessary equipment.
RS-Biopharma's Approach:
RS-Biopharma first compiled a longlist of potential technical solutions based on the BREF (Best Available Techniques Reference Document) and defined clear evaluation criteria for selecting the most suitable technology. Based on these criteria, a shortlist was created.
Subsequently, a Request for Quotation (RFQ) was prepared and sent to selected suppliers from the shortlist. Based on the received offers, RS-Biopharma
prepared a comprehensive final report and recommendations. Furthermore,
RS-Biopharma supported the client in successfully conducting a field test (trial) to validate the most suitable solution under real-world operating conditions.
Results:
The customer now has not only a proven and functional solution for compliance with the operating permit, but also extensive data from the successful field test and a professional comparison of the best available technologies, including their performance and limitations. This solid data foundation enables a technically sound dialogue with environmental authorities and ensures that future
regulatory requirements remain realistic and feasible.
Project management for the construction of a QC laboratory
Project Overview:
An RS-Biopharma client faced the challenge that the responsible project
manager had left the company, leaving a project for the construction of a new QC laboratory incomplete. Construction had already begun, while the design phase was still ongoing. Due to this unstructured project progress, management
questioned the project's benefits and economic viability. RS-Biopharma was
engaged to take over the project and complete it successfully.
RS-Biopharma's approach:
Due to the overlapping project phases, RS-Biopharma convinced the
stakeholders involved to define the open project scope in a structured and
complete manner and to finalize it in parallel with the ongoing construction phase. At the same time, we developed detailed construction, safety, and
execution plans to ensure that the laboratory construction could continue with minimal disruption.
Through regular progress reports and thorough status and value analyses,
management was kept transparently informed about the project's progress and convinced of the economic and technical benefits of an orderly project completion.
Results:
The design phase was completed without any gaps in the ongoing construction. Construction continued without significant delays, and the QC laboratory was successfully completed in accordance with the company's expectations.