Partnership-based cooperation right from the start - success keys in the manufacture of a Coriolis flowmeter

The Proline Promass U 500 is the first single-use flowmeter for biopharmaceutical applications in the life sciences industry. It is the answer to the change from multi-use to single-use products and from batch to continuous production. The Proline Promass U 500 offers multivariable measurements, improved reliability, high accuracy and industry compliance according to cGMP. The flowmeter is particularly suitable for upstream and downstream applications in the monoclonal antibody process.

The sensor consists of a disposable component, which is available in four nominal sizes (1/8, 1/4, 1/2 and 1 inch), and a permanently installed base unit, which is suitable for all nominal sizes. Heart-beat Technology automatically recognizes the flow range and checks the validity of the factory calibration after installation. This simplifies commissioning and eliminates the need for on-site calibration. Equipped with an integrated web server, WLAN and up to 4 I/Os, the transmitter is easy to operate and provides additional process and device information.

Minimizing risks and saving costs through joint solutions

The idea and the benefits (Intended Use) were clearly defined by Endress+Hauser (Schweiz) AG at an early stage. The resulting requirements had to be met. In addition to the flawless functionality of the end product, these were as follows:

• Development of the necessary plastic parts with definition of the specifications (URS)
• Valid manufacturing conditions in the injection molding process
• Clear traceability of the customer serial number
• Electronic workstation-independent control scan process of the ID number from the ERP system through all manufacturing processes to the label on the final packaging and to the application
• High particulate and microbiological requirements
• Development of a product-specific validated cleaning of the disposable measuring tube
• Development of a valid leak test to prove the validity of the assembly and ultrasonic welding process
• Low-germ final packaging (blister and labeled double-bag packaging)

A chieving a solution together and the ultimate success of the project was made possible by very successful cross-departmental collaboration and consistent project management in which the set milestones were met. This enabled the partners in the project to make the right decisions quickly. The decisive factor here was certainly the near-series use of rapid tooling tools, which were manufactured in-house by SAMAPLAST AG. This made it possible to provide the customer with samples for practical tests. In the course of the project implementation, it was confirmed that the early use of rapid tooling tools clearly provides added value and only brings many advantages if the partner also has many years of in-depth expertise. This enabled E&H to recognize problems at an early stage and react accordingly.

The key to success?

SAMAPLAST met the high demands on the dimensional accuracy and tolerances of the plastic parts on the basis of partnership-based development work, years of know-how in toolmaking, injection molding under clean room conditions, expertise in the assembly and US process and the high-precision injection molding tools manufactured in-house and the existing validation concepts. New challenges such as specific cleaning equipment with subsequent development of valid washing processes, a successful product-specific valid leak test based on a sequence of stable valid US welding processes and the electronic workstation-independent control scan process for gap-free traceability were developed, implemented and validated on a risk-based basis together with Endress+Hauser (Schweiz) AG and partner companies (long-standing suppliers) on the basis of the specifications (URS).

The deciding factor here was certainly the trust of the customer Endress+Hauser (Schweiz) AG in SAMAPLAST AG, which was able to influence the design, manufacturing process and packaging at an early stage on the basis of a very early collaboration, which guaranteed manufacturability and thus reduced costs..

Risk-based validation of all critical manufacturing processes

In the course of this project, the injection molding process was validated by SAMAPLAST AG in accordance with EN ISO 13485 on the basis of defined framework conditions such as qualified machines/peripheral equipment and a customer-neutral basic validation of the injection molding process. SAMAPLAST's process know-how and the customer-neutral basic validation saved time and costs.

The validation of the product/customer-specific cleaning and US process, the specific leak test, but also the electronic workstation-independent control scan process was carried out according to the state of the art (e.g. GHTF) in cooperation between Endress+Hauser (Schweiz) AG, the individual suppliers and SAMAPLAST AG, based on a joint process development. What became apparent in the course of these validations and the resolution of stumbling blocks was the importance of a good partnership and flexibility of all companies involved, including the system manufacturer, producer, software service provider and distributor, and the development of the necessary and in-depth process knowledge based on a DoE (Design of Experiment) to create the basis for the process validation. This was the only way to identify all risks and successfully complete the validation. In addition, the short distances to the partners, but intensive discussions and test series on site were an advantage.

Lessons Learned?

Partnership right from the start, many years of expertise of all those involved, transparency and regular joint meetings on site during the implementation process reduce risks, minimize costs and time and contribute significantly to the success of the project and the market. Another lesson learned in some cases was the creative freedom in the project and the high level of trust in the implementation, which led to the teams involved coming up with new ideas and specialist knowledge, resulting in fast and creative solutions and preventing stumbling blocks from coming to fruition. In the spirit of DOING IT TOGETHER SUCCESSFULLY.