Aseptic manufacturing systems play a critical role in the production of sterile products in the pharmaceutical, biotech and medical device industries. As a custom machine builder who addresses cGMP aseptic applications, we understand the importance of designing and building aseptic manufacturing systems that meet the highest standards of sterility and reliability.
Maintaining Sterility
When it comes to aseptic manufacturing systems, maintaining sterility throughout the manufacturing process is crucial. That’s why we design our systems to integrate well into an isolator with features such as laminar airflow, positive pressure, and aseptic connections to minimize the risk of contamination. We also prioritize ease of cleaning and sanitization to ensure that the manufacturing environment remains sterile and safe for production.
Engineered Automation
Automation is another key aspect of aseptic manufacturing systems that can greatly improve efficiency and production capacity. Keller’s team has experience in designing systems that range from fully automated to semi-automated, depending on the customer’s specific needs. Automation not only reduces error, but also enables the system to operate continuously and efficiently, resulting in a higher throughput of product. A fully automated system in an isolator minimizes human to product contact and opportunities for contamination. Keller Technology has been very successful in integrating robots specifically designed for aseptic environments into isolators for fully automated systems.
How Keller Technology Can Help Your Production Process
We understand that each customer’s needs and production processes are unique, and that’s why we work closely with them to develop a customized solution that meets their specific requirements. Our team of experienced engineers uses high-quality materials and components to ensure that the system is reliable, durable, and easy to maintain. But our services don’t stop at design and build – we also provide comprehensive validation and testing services to ensure that the system meets all regulatory requirements and standards. Validation services include installation qualification, operational qualification, and performance qualification.
While the majority of aseptic applications are standard to semi standard filling of syringes or vials for parenteral products, at Keller Technology we have found our niche in non-standard applications. This means we are typically working with a customer who has a novel delivery modality, this tends to be in the form of a combination product. For example, we are often tasked with producing systems which coat devices with an API.
Aseptic manufacturing systems are a critical component of sterile product production. With our expertise in design, build and validation, we are committed to delivering aseptic manufacturing systems that exceed expectations and meet the highest standards of quality and safety.
Get started with Keller Technology
Does your production process need assistance? Contact the experts at Keller Technology to get started today.