Services
End-to-End Engineering Services for Long-Term Success
Our configurable, single-use products and systems sit within a holistic package of customer service and support. Our experienced team has expertise in upstream and downstream bioprocessing workflows, from R&D to pilot to commercial manufacturing, and we leverage this broad perspective to help our customers seamlessly integrate our single-use systems into their unique workflows in the most cost-effective and sustainable way. This empowers them to reach for their goals, well into the future.
Starting With the End in Mind
At Wautoma, we engineer with the end in mind, working from commercial scale down to R&D. This means that the entire workflow is designed to be cost-effective at scale, influencing all of the technology and engineering choices from the start. Via our engineering services, we can work with the customer to make significantly different decisions early on that optimize the entire process, rather than simply tweaking individual unit operations.
By keeping the end goal in mind and focusing on the entire bioprocess workflow, we deliver innovative, sustainable, and cost-effective solutions that set us apart. Ultimately, our engineering services are about helping our customers deliver therapeutics to patients in the most efficient and low-cost way, with the hope that these benefits and savings will be passed on to patients.
Zooming Out for the Full Picture
When configuring and implementing our single-use systems for a customer’s workflow, our engineers take a step back and consider the entire process around that unit operation. We look at the processes that come before and after our technologies to understand how they fit within the bigger picture, and can then make informed decisions about how best to configure our systems to optimize the workflow as a whole.
This also means considering the customer’s future needs so that we can configure our single-use systems to be scalable and sustainable. This long-term perspective drives us to create and implement technologies that not only meet current needs but are also forward-looking.
Close Collaboration From Day One
Our engineering services are built around relationship and collaboration throughout the entire product lifecycle. We work to understand our customers’ needs, challenges and long-term goals, design the best solution for their application, and support them from implementation to aftermarket services to empower their long-term success.
1. Identify
Our experienced process engineers work closely with customers to understand their long-term goals and identify workflow improvements. By assessing both upstream and downstream processes, we design cost-effective, sustainable solutions tailored to their specific unit operations.
2. Design
After the goals are established and the optimal workflows are identified and agreed upon, our engineers work to optimize our single-use systems for the customer’s unique application and process.
3. Deploy
Next, we take the optimized workflows and implement them into the control system. After performing a factory acceptance test, we deploy the system into the customer’s facility.
4. Test
We perform site acceptance testing, and installation qualification/operational qualification, and can support performance qualification and validation.
5. Sustain
Our goal is to provide a solution that exceeds expectations, minimizing the Total Cost of Ownership and providing quality aftermarket support services for the customer’s long-term success.
Backed Up By Expert System Engineering Services
At Wautoma Biotech, we know that at the heart of any good product or solution is the control system. Our experienced control system engineers follow the standards and guidelines that are critical to meeting regulatory requirements in order to minimize risk for our customers. We do this by taking advantage of the best available technology in the industry today. Through our system engineering services, we leverage hardware and software solutions that allow for a Pharma 4.0 approach, which increases productivity, reduces costs, and improves compliance.
S-88
21 CFR
GAMP5
We use GAMP5, the international guidance document from ISPE that provides a risk-based approach for the entire production process. This allows our product and control system to have the regulatory compliance our customers need, with an assurance of quality that comes from the reliability and robustness this standard provides.
Contact us to find out more about our products and services.
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