In the PSM GmbH – Pharma CDMO – Presentation of “flexfill” filling-line. As a CDMO, our latest state-of-the-art fill & finish technologies allow us to respond fast and flexible to the needs of our customers. Especially in the area of clinical phases but also commercial GMP production of small to medium batch sizes, our equipment offers highest process reliability thanks to scalable processes. Learn more about our flexible filling lines for ready-to-use syringes, vials and cartridges by watching our video.

We are very enthusiastic about the fast and flexible production of our new packaging machine. We congratulate Körber on passing the FAT. After passing the test a special tradition takes place at Körber. The PSM is presented with a bell and as soon as it rang, the factory hall applauded. Many thanks for the kind support and commitment of the Körber team. Modular and expandable, the Dividella NeoTOP x offers the maximum flexibility of vials, syringes, injectors, ampoules, blisters, and almost unlimited other pharmaceutical products. The machine is adapted to the specific requirements of pharmaceutical production. It is ideally suited for the production of small to medium batch sizes.

Our extension project for our services in the area of API Manufacturing, Product- and Process Development and aseptic Fill & Finish for small to mid-size batches is about to be commissioned and qualified. In the upcoming months, we will give you a close insight to our cleanrooms, facilities and technologies.

Stay tuned …

We are very pleased that Minister of Economic Affairs Jürgen Barke visited PSM GmbH in Schiffweiler / Germany.

PSM GmbH is a German contract development manufacturing organization (CDMO) for API manufacturing, product & process development to small to mid-scale aseptic GMP fill & finish services. During the site visit, Ahmad Mansour (Europharm) and Bianca Bohrer (PSM) informed Jürgen Barke about the progress of the expansion project at the Pharmacampus in Schiffweiler which was funded partially also by the State of Saarland with around 7 million Euros.

Although some of the cleanrooms are already qualified by now and cannot be accessed, the Minister took the last chance to see the facility as well as the fill & finish technologies supplied by Groninger and Skan.

The company Martin Christ Gefriertrocknungsanlagen GmbH built a suitable freeze dryer for the robocell – a fully automated, gloveless robot filling line from the Groninger and SKAN.

The freeze dryer has a capacity of around 4 sqm and is equipped with an ice condenser with a capacity of approx. 65 kg. The PSM team was on site in “Osterode am Harz” to execute a comprehensive testing procedure – all functionalities, a performance run, a fully automated cleaning procedure (CIP) as well as the sterilization process (SIP) were tested.

The Lyo passed all tests without any deviations. Congratulations!

We are pleased to announce that the machine will soon be shipped to PSM GmbH. With the Christ freeze dryer, lyophilized pharma products can also be offered for small and mid-size batch sizes.

We are pleased about the delivery of the robocell, another milestone in our expansion project has been reached. The hard-working employees of SKAN, groninger and PSM are joining forces to install the system.

With the latest generation of aseptic filling systems, all current regulatory requirements of the pharmaceutical industry are met. In cooperation with the company SKAN, groninger developed a gloveless, fully automated filling line based on robot technology. Human intervention in the core processes of pharmaceutical filling is now a thing of the past. Whether installing a filling path or the handling of active and passive viable air monitoring – the robocell carries out these processes automatically without human interventions. This increases process reliability and sterility assurance drastically especially when processing high potent drugs, viral victors, cell & gene drugs, and others in our Pharma 4.0 CDMO plant in Schiffweiler/Germany.

Especially with regard to the revision of the EU GMP Annex 1 draft, robocell sets standards:

•  The reduction / elimination of human intervention in the aseptic filling process.
•  The use of intelligent robotic solutions
•  The support of a holistic Contamination Control Strategy (CSS)

The contamination control strategy in particular is an essential element for pharmacists and contract fillers. For this reason, during development groninger placed great emphasis on providing the best possible support for customers and users of the robocell. Detailed CFD analyses of all critical areas as well as the joint development of isolator and filling system ensure that possible contamination is downgraded to a technically minimal risk.

Highlights of the robocell

• Maximum flexibility in the use of packaging materials
• Shortest set-up times enable highest OEE values in segment comparison
• Insertion and installation of parts that come into indirect contact with the product
• The implementation of a PUPSIT in robot-assisted lines

 

An exciting day at PSM GmbH, the switch cabinets are inserted by crane over the roof through the window. The control center for the groninger filling plant is completely wired and installed after about a week. A strong performance by the assembly team, with sensitivity and precision the elements are assembled perfectly.

 

The PSM GmbH was in Crailsheim at groninger Group for the Factory Acceptance Test (FAT) for the RoboCell.

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The first high flexible fill&finish line for syringes, cartridges and vials with an annual capacity of around 30 Mio. containers…

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Shaping the future on robotic gloveless aseptic Filling with the ISPE D/A/CH – Germany, Austria, Switzerland

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