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An increasing number of diagnostic products and projects require comprehensive expertise that goes far beyond filling and closing. Optima Pharma specializes in the development of turnkey solutions and takes central responsibility: multiple systems – from one source. We spoke to Christian Müller, Director Sales Diagnostic Global at Optima Pharma, about the services, background information and customer benefits.
We see considerable variety in our line of work. For instance, we are currently working on a project for cancer diagnostics, a personalized medicine that demands extremely high dosing accuracy. The crucial substances for the reagents, the antibodies, are obtained through elaborate animal husbandry. Specific requirements of a diagnostic product like this lead to functions we integrate in-line. This can include minute dosing quantities, vacuum closing, leak tests, air-drying systems, freeze-drying, palletizing, or the assembly of the containers, among many others.
Diagnostics are also applied in criminology. In such cases, stringent hygiene measures are typically in place to prevent the introduction of foreign DNA into the tests. Enhanced hygiene standards are also essential in medical diagnostics, as seen in blood platelet analysis, where the inclusion of any dust particles is strictly prohibited due to their potential to alter the test results.
With a combination of in-house skill and collaboration with external partners as needed, Optima Pharma meets customer expectations and diverse technical requirements. What truly sets us apart is our process technology expertise. In other words, combining and integrating a wide variety of functions and process steps into a turnkey line, a practice we have been perfecting in the diagnostics field for several years. Our diagnostic customers benefit from the experience and expertise we have gained over many years of providing turnkey solutions to the pharmaceutical industry. This ensures a strong and well-established technical foundation for such tasks. Additionally, our close partnership with our customers is of utmost importance. We work hand-in-hand with our customers to develop system and customized solutions. This collaborative approach is a key factor in our success.
The field of diagnostics turnkey, for us, means assuming overall technical and organizational responsibility for the project and serving as the primary contact for our customers, even when integrating system functions from third-party companies.
The turnkey approach begins with engineering. Here, we use simulations to harmonize various functions. Simulations test and optimize the entire system – or the combination of system components – before actual constructions begins. For example, we simulate factors such as flow patterns over certain machine sections when a laminar flow is required. This also encompasses the evaluation of component strength, the establishment of the system’s atmosphere, the additional suction for explosion protection, the potential for condensation, and more. Interface design also plays a crucial role in this process. By taking this step, we significantly reduce potential issues before building the system of stainless steel.
One of the biggest advantages is that a turnkey diagnostic system is always fully assembled at our facility before it goes to the customer site. The entire system is harmonized during assembly at our facility. The turnkey approach allows us to identify and address critical points long before the installation at the customer site. The customer only gets here when the system has already been extensively fine-tuned. This saves substantial time because these critical points are addressed much more efficiently during our assembly process than on site at the customer location. Project management is centralized at our facility in Schwäbisch Hall, starting from the engineering phase, through assembly, and up to on-site installation. For international projects, for example in the USA or China, this is done in close cooperation with local Optima employees. In all cases, the customer has a single, central point of contact for their project.
In the end, the customer benefits from a significantly reduced time-to-market and fewer disruptions at their site.
