A milestone in packing material and process development

By: Bausch + Stroebel

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KCP: The potential of this equipment has by far not been exhausted yet

With the KCP Bausch+Stroebel took the next evolutionary step into automation. Having a flexible filling platform with four configurable modular processing stations, our customers can simulate a variety of different industry standard dosing, closure placement, sealing, and inspection arrangements currently used in commercial production of parenteral products.

With two clean room robots, the filling and closing machine provides a wide range of applications for small batch production or process and product development. Virtually any customary container (vial, syringes, and cartridges; plastic or polymer or glass) can be processed on the line with minimal changeover time. Completely different work steps can be integrated in the work flow.

Up to four work stations can be integrated in the KCP as required and can easily be customized by the operating staff. To support cGMP traceability requirements and batch record documentation, Bausch+Stroebel has developed a system to verify if the selected size parts at the HMI match the size parts that are installed on the machine (HMI-prompted recipe verification of the size parts).

The two aseptically designed robot arms never cross between the laminar airflow from the RABS and an open container. They are always below the open containers, thereby ensuring first air is never broken by robot processing activities. The KCP is compatible with a RABS or isolator installation with optimized air flow verified with detailed Computational Fluid Dynamics studies (CFD).

The KCP is capable of testing the handling of a broad range of packaging material, such as plastic or glass containers (vials, syringes, cartridges), coated, siliconized or uncoated stoppers and plunger closures.

Furthermore, the KCP provides the possibility for In-Process Control (IPC) of up to 100% of the production batch or at regular predefined intervals, thereby ensuring documentation compliance of batch data.

Our customers are therefore in a position to evaluate all possibilities and risks during process development prior to production. Thus, they optimize packing material composition and product compatibility, thereby ensuring troublefree production and absolute process reliability.

The filling, stoppering, crimping and control technologies on the KCP are fully scalable to other high speed production lines. All batch parameters are transferable and applicable to high speed production.

Furthermore, a big advantage for our customer is to have that knowledge and testing possibilities at their site.

With the KCP, Bausch+Stroebel can supply an extremely flexible filling and closing machine for comprehensive development and small batches (the model at the Interphex can process up to 1,000 containers per hour).

High flexibility and time saving are the advantages for the user of the newly developed KCP.

The KCP5060 gives ultimate flexibility to test any packaging material configuration provided that the appropriate change parts are installed. Our best example of the breadth of flexibility available is the custom KCP5060 purchased by West Pharmaceutical Services. West is currently testing 7 different containers (vials, syringes and cartridges), 21 different closures (stoppers, seals, caps), 5 filling and closing processes (rotary piston, time/pressure, peristaltic, sensor filling, and vacuum filling and closing) in 98 different configurations (bulk feeding and RTU components) on their KCP. The range of processing sequences the robot-equipped KCP is able to cover is enormous. However, the full potential of this equipment has not yet been realized. New applications are continuously identified and the system can be expanded at any time for additional future processing capabilities.

Erik Anderson, Principal Product Development Engineer from West Pharmaceutical Services states how the KCP is applied at West and how it enhances the product development life cycle:

“To characterize the performance of all fill finish process variations as well as all closures, seals, vials, cartridges and syringes (commercial and prototype) requires the use of an extremely robust, innovative, and flexible filling platform. After much scrutiny via a West user requirements matrix vetted against a wide range of well-established OEMs, this project was ultimately awarded to Bausch+Stroebel because of their ability to meet the majority of user requirements, innovative culture, track record of proven performance, and technical competency.

Since project inception, multiple challenges have been overcome, processing capabilities have increased, and new applications for the use of this custom filling platform have been identified. Some of these applications include performance characterization of containers and closures, machinability performance evaluations, and testing of novel fill finish process improvements. West is very pleased with the progress to date with Bausch & Stroebel and is looking forward to continued success.”

About INTERPHEX

Official blog of: INTERPHEX New York - www.interphex.com
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