PCI is the trusted partner for the biopharmaceutical industry, providing solutions with the shared goal of improving patient´s lives. With a 50-year track record of excellence, PCI stands for outsourced solutions to manufacture, package and deliver medications from the earliest stages of development through to commercial launch and ongoing supply to patients all over the world.
PCI combine best-in-class technologies with cutting-edge research supported by an exeptional team of people, delivering the highest level of regulatory compliance and quality standards. The PCI portfolio comprises the following Services:
„The groninger downstream syringe assembly equipment enables us to offer the greatest flexibility for our clients. We have never had such a project with such flexibility in syringe assembly. With this technology, PCI can convey the syringes via tray or via nest. The syringes can be equipped with safety device, add on finger flange or even backstops. This equipment allows us to label round and squared safety devices with the highest precision available. This makes a big difference in serving the CMO marketplace,” says Chris Blanton, Vice President and General Manager.
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market.
Get more information about PCI Services: www.pciservices.com
PYRAMID is a CMO focused on parenteral drug products, offering a comprehensive pipeline of services to pharmaceutical and biotech companies.
Established in 1988, the company is based in Southern California, USA. A three-building campus, conveniently located between Los Angeles and San Diego, covers over 90,000 square feet of state of the art facilities, allowing PYRAMID to offer a wide range of services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both Clinical and Commercial products. The analytical and development laboratory offers product development and analytical capabilities performing dozens of methods in a cGMP/GLP setting. Microbiology laboratory equipped with the isolator for sterility testing supports manufacturing of injectables.
PYRAMID is based on a “one-stop-shop” concept which is focused on offering their clients a wide array of services for all phases of parenteral drug development, from early stages to commercial manufacturing:
For 30 years, PYRAMID have provided clients with Top Quality reliable services assuring that their critically important parenteral products reach patients in need.
„The groninger CombiFill system allows us to meet not only today´s customer requirements but also future demands. Processing Ready-To-Use (RTU) syringes, cartridges and vials on one line is a huge benefit for us and our clients. The rapid changeover with the groninger QuickConnect technology supports us in keeping our uptime at the highest level. Overall, the FlexFiller line will increase both our capacity and flexibility which is critically important for us as a CMO”. Medhat Gorgy, President and CEO.
PYRAMID is a CMO focused on injectable products offering development and manufacturing from clinical to commercial scale to the global market.
Get more information about Pyramid: www.pyramidlabs.com
BioConnection is one of the first European CMOs to provide sterile production facilities as well as expertise for small/ medium sized (bio)pharmaceutical companies. With BioConnection you have access to aseptic production of small-scale clinical batches, filling and freeze-drying as well as 250L scale production of commercial batches. All under one roof and EMA and US-FDA certified.
BioConnection services customers from a FDA approved manufacturing site in Oss, the Netherlands. Besides their own facility they have access to various partners across Europe to enable unmatched flexibility in solutions, capacity and capability. The cornerstones of their CMC services are:
„The INTEGRA is the perfect machine for a CMO as we are. We can cut down our set-up and changeover times by around 50% based on the QuickConnect technology and the elimination of format parts in general over traditional bulk filling lines. To further support our business as a CMO, the Groninger FastLane approach is game changing in the industry when it comes to flexibility unknown future demands. The Groninger expertise in bulk filling lines especially for CMOs and our know-how in drug manufacturing resulted in a great cooperation and partnership our clients benefit from,“ says Sjaak Stevense, Director Commercial Productions.
BioConnection is a contract services and manufacturing organization for the development and manufacturing of injectable (bio)pharmaceutical products.
Get more information about BioConnection: www.bioconnection.eu
FlexCon 10 is an assembly machine for inserting plunger rods in syringes, labelling and inserting syringes in safety devices.
Product safety takes first priority in all three process stages on this machine. Transporting of the individual syringes has been optimized to achieve maximum care, and can be optionally performed without any contact at all. Insertion of the plunger rods is electronically controlled. Labels are precisely applied and syringes reliably inserted in their end position in the safety devices in a continuous controlled insertion movement.
A joint cross-company development project by groninger and SKAN resulted a unique line concept for vial processing – aptly named INTEGRA.
The INTEGRA product family is a sophisticated line concept that integrates both isolator and fi lling machine to grant a unique customer experience. This vision shared by groninger and SKAN has been realized in the shortest period of time.
Available with different line speeds up to 400 objects/minute and with oRABS or standardized isolator technology, the INTEGRA becomes the latest member of the groninger Business Line.
Also, groninger and SKAN are breaking new ground visually. The innovative product family already sends a clear message with its puristic design.
That‘s why INTEGRA already received the ACHEMA Innovation Award 2018.
Creme 60 is one of the highlights in the groninger Business Line series. The system can produce up to 60 units a minute and processes cream jars, make-up bottles, airless pumps, mini-dispensers, mini-rollers and lotion bottles.
Creme 60 emphasizes a high degree of flexibility in this advanced technical solution. Additional technical features and options can be easily added later as required without complications. Or select the complete system from the start to cover all production options.
Groninger offers you customized technical solutions – quick configurationwithout setups. The groninger Business Line concept combinestop product quality with short delivery times. We also guarantee servicewith immediate solutions whenever required.
Advantages of Creme 60:
FlexPro50 installations worldwide
ContainmentThe integrated automatic (via HMI) Toxic Air Filter Module (FZ-ATAF) is installed close to the contamination source and reliably prevents leakage of highly active substances. Convenient operation by HMI, easy cleaning (WiP) and safe (OEB6).
Total isolator height of 3 meter /10ftThe integrated Franz Ziel isolator technology fits in a standard clean room. Ideal for retrofits in existing facilities or modular facilities where no technical area is limited or even not available.
LyoShuttle Loading SystemIntegration of Martin Christ‘s LyoShuttle – the innovative, robust, and wireless isolator-friendly loading and unloading system freeze dryer.
Robotic handlingEliminates human intervention and reduces risk to products.
Operator friendlyErgonomically designed with operator and interventions considered to reduce risk.
3 formats on 1 platformProcessing of syringes, vials and cartridges.
… and many more
Fully automated processesThe fully automated line execution eliminates the need for human intervention into the filling line.
Infeed transfer optionsThe groninger No-Touch-Transfer and the Franz Ziel H2O2 chamber provide safe and simple transfers of RTU containers into the isolator.
Smart fill technologygronigner offers a wide range of features to eliminate product waste during priming, production and run-empty phases.
Quick Connect philosophyDesigned for tool-less change over and minimal format parts.
Freeze drying capabilitiesThe Martin Christ portfolio offers state of the art freeze dryers with a wide range of PAT-Tools and SCADA-System LPCplus.
Zone conceptsWith individually controlled isolator modules, different requirements for various OEB and BSL levels can be met.
Complete Downstream Equipmentgroninger offers a comprehense downstream equipment for object processing, from plunger rod insertion to safety device assembly and labelling.
FlexibilityCapable of processing nested vials, syringes and cartridges in one line configuration and bulk vials, trayed vials and eye drop container by exchanging machine trolleys.