Requirements for filling and finishing equipment have shifted from high speed filling lines towards the processing of significantly diverse biotech products in smaller batches. This market trend requires new solutions for aseptic processing from machine building companies.

Groninger & Co. GmbH recently introduced the FlexPro 50, a modular filling and closing system designed to process Ready-To-Use vials, cartridges and syringes, as well as vials in bulk and trays. FlexPro 50 lines can be executed with manual or fully automated process steps depending on the requirements. The machine concept is based on modular machine trolleys used in standardized isolator modules supplied by Franz Ziel GmbH. Although nested Ready-To-Use vials, cartridges and syringes can be processed on one line configuration by just changing format parts, additional flexibility is given by exchanging the machine trolleys to process also vials in trays or vials in bulk in the same line configuration.

“This flexibility for processing small batches is unique compared to other machine designs in the market and grants huge benefits for our customers.” states CEO Jens Groninger.

Depending of the line configuration, an output of up to 4,700 objects per hour is possible. The standardized isolator modules were designed around the processing steps with the results of a very compact machine design and space savings of about 40%.

The isolator works independently of the facility´s HVAC system – the entire technical equipment is built in the isolator with an overall height of less than 3 meter (9.8 feet). Hand gloves on front and backside of the main and add-on isolators allow machine access from both sides. The new Direct-Injection-System reduces the decontamination cycle by about 50%. The line can be changed to process different products in around two hours. Additionally, all qualification documents of the machine and the isolator are put together in a pre-defined documentation package to offer the highest level in security and efficiency at the Factory Acceptance Tests (FAT).

All isolator and filling modules are based on the Ready-Engineered approach to reduce engineering efforts and ensure the shortest delivery time. At Groninger, the Ready Engineered approach stands for a standardized modular design, offering clear cost advantages and reduced lead times. As part of a turn-key solution, Groninger cooperates with companies Franz Ziel GmbH for isolators and Martin Christ Gefriertrocknungsanlagen GmbH for freeze-drying modules.

A recent project with Bryllan LLC, USA required an isolated line to process live virus, hormone, cytotoxic and sterile products in a new filling suite. Dr. Douglas Bryans, Chief Operating Officer of Bryllan LLC states that he chose the groninger FlexPro 50 for the company’s new multi-product facility because the FlexPro system offered a flexible and configurable operating platform that provided significant advantages in a multi-product sterile filling operation. “Groninger is a great partner providing excellent technical and operating expertise in their design solutions for the FlexPro system,” said Dr. Bryans. “Their innovative approach to solving process problems and commitment to quality builds confidence in our partnership.”