Founded in 1920, Kahle Automation is the world leader in designing, building and implementing automation systems for medical, pharmaceutical and healthcare device companies. Kahle creates custom automation systems that turn customers' requirements into realities, with 150,000 man-hours dedicated to design every year and the most comprehensive portfolio of technology in the industry.

Recently, when completing a particularly challenging and successful project, Kahle asked its customer, a knowledgeable engineer passionate about his work, "Why did you end up choosing Kahle?" He said that when he visited the company's competitors, they gave him two choices – choice A or choice B. When he came to Kahle, it gave him a blank piece of paper and said, "Let's develop the ideal solution to meet your requirements." That's how he knew he was in the right place.

Automation is not automatic, and automation projects are rarely simple. Kahle believes that limiting choices comes at a cost – decreased reliability and efficiency. It considers its customers to be partners, and that's why every Kahle machine is custom-built to meet the exact needs of the project.

No limits in choice means no limits in scale or technology. Kahle is proud to offer its partners automation solutions for projects of any size, while also providing the quality of service one finds at a privately held company.

Kahle's dedicated engineering team focuses on developing solutions to improve overall quality for its customers in every aspect of the process, from developing its own feeding systems to using proprietary precision fluid dispensers, assembly movements or testing applications. The intention is to use or develop solutions to exceed the customer's standards and requirements.

How a project develops

All the information gathered in the sales phase is turned over to the engineering department. Design teams, validation members, project managers and assembly teams are chosen based on their experience with a particular product or process. The specification is reviewed, and the sequence for the assembly and inspection processes are developed, along with the traceability matrix. Based on the sequence of operation, the FMEA is developed to identify critical requirements as well as risks associated with the project. Once identified, these are prototyped to prove that the manufacturing process can be scaled from launch line to high-speed automation.

Kahle considers the validation of the design of the machine as one of the most important activities for an automation partner. A vital step in the planning and executing of validation for the project is to create a quality plan or master validation plan. This plan provides the rationale for the foundation of the process validation, starting at the functional specification, and carrying through all of the design and verification processes to the culmination of equipment acceptance testing (FAT/SAT) and process validation at the customer's facility. Kahle complies with the GAMP5 validation guidelines and designs equipment to meet ISO 7 clean room (class 10,000) requirements.