CMO Nest

von gadmin | Apr 24, 2020

Technical details

Processing of up to 60,000 objects/h with up to 100% IPC
Processing range of all available RTU components (up to 4 inch tub size)
All common (combi-) filling systems
Hygienic design for highest OEB and BSL level
Different gassing and stoppering options
21 CFR Part 11 compliance
Siemens and Rockwell controls

PCI, a provider of integrated pharmaceutical
development services

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:

Drug Development and Manufacturing
Clinical Trial Services
Commercial Packaging Technology

„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.

About PCI

PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market.

Sector: Pharmaceuticals
Special field: Clinical Trial Manufacturing, Packaging, Storage, and Global Distribution, Analytical Development and Testing, Commercial Packaging, QP Services and Formulation Development and Drug Manufacturing
Location: Philadelphia (Pennsylvania, USA)
Founding: 1967

Get more information about PCI Services: www.pciservices.com

PYRAMID, a One-Stop-Shop CMO for pharmaceutical and biotec companies

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:

Analytical Method Development and Validation
Formulation, Lyophilization and Process Development
Clinical and Commercial Vial and Syringe Fill / Finish
Clinical and Commercial Product Lyophilization
Labeling and Packaging; Parenteral Storage and Distribution
API and Drug Product Stability Studies
Clinical Trial Material Management

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.

About PYRAMID

PYRAMID is a CMO focused on injectable products offering development and manufacturing from clinical to commercial scale to the global market.

Sector: Pharmaceuticals and Biologics
Special field: Parenteral Products, Fill Finish, Analytical Support, Liquid & Lyophilized Drug Products, Formulation & Lyophilization Development, Oligonucleotides, Peptides and Biologics
Location: Costa Mesa (California, USA)
Founding: 1988

Get more information about Pyramid: www.pyramidlabs.com

BioConnection, a CMO specialized in injectable (bio)pharmaceutical products

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:

Drug product development
Fill and Finish
Freeze-drying
Clinical Trial Material services

„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.

About BioConnection

BioConnection is a contract services and manufacturing organization for the development and manufacturing of injectable (bio)pharmaceutical products.

Sector: Pharmaceuticals
Special field: Drug Product development Fill and Finish, Freeze-drying, Clinical Trial Material services
Location: Oss (Netherlands)
Founding: 2005

Get more information about BioConnection: www.bioconnection.eu

FlexCon 10

Syringe Assembly Machine

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.

Highlights:

Processing of syringes, vials and cartridges possible
All infeeds on one side of the machine (for plunger rods, finger flange, labels, safety devices)
No rejection of good syringes
Output: up to 4,200 objects/h
Nominal processing range: 6.85 – 17.05 mm
Filling volume: 0.5 – 10 ml

INTEGRA

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.

Highlights:

Unique operator friendliness
The INTEGRA is designed for greatest operator friendliness. The ultra slim line set-up allows to operate the entire line from one side where every part of the machine can be reached easily.
QUICKCONNECT – Shortest changeover times
The focus on the INTEGRA is to ensure the shortest set-up time possible. By eliminating over 50% of the conventional format parts and making the existing ones “intelligent” with an individual data matrix code, operators achieve a safe changeover and shortest set-up times.
SMARTFILL – Minimum possible product loss
A maximum in machine efficiency is granted with some unique features. Starting with minimum product loss during run-in and run-empty modes, all processes are set up for optimal effective line speed and minimum container loss.
Ideal for processing toxic products
The shift of the sterile barrier from the technical area into the machine, the clean design and no vacuum on the entire line in combination with an ideal design to drain cleaning water differentiates the INTEGRA significantly from other solutions
on the market.

Creme 60

Filling and closing system for cremes, lotions, make-up and much more

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 configuration
without setups. The groninger Business Line concept combines
top product quality with short delivery times. We also guarantee service
with immediate solutions whenever required.

Advantages of Creme 60:

High machine availability and productivity
The highest process reliability with precise filling control
Optically error-free filling results
Secure sealing of containers
Ability to process a large range of formats and products, including temperature-controlled fill products
Different pump sizes can be combined and controlled independently
Easy to maintain and easy to upgrade, simple and ergonomic change-over from product tanks and filling pumps
Maximum quality of finished products
Use of high-quality and durable materials
Spare parts with short lead times
Made in Germany, made by groninger

Process Solutions.

Your demands. Our customized solutions.

FlexPro 50: Modular machine concept for aseptic and aseptic toxic processing of syringes, vials, cartridges and eye drop container

Technical Features

Designed for highest OEB and BSL level
Processing of up to 5,000 objects/h
RTU container up to 4″ tub-size
Vials in bulk, trays and eye drop containers
Manual or fully automed IPC up to 100%
Peristaltic pumps, rotary piston pumps or combi filling system
Designed to use groninger single-use rotary piston pumps

Nitrogen gassing during filling and stoppering
Vacuum filling and stoppering
Robotic denesting and single-reject
CE and UL version
Changeover time including VHP cycle of around 2 hrs
Siemens and Rockwell controls
21 CFR Part 11 compliance

FlexPro50 installations worldwide

FlexPro 50

Our Highlights

Containment
The 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 /10ft
The 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 System
Integration of Martin Christ‘s LyoShuttle – the innovative, robust, and wireless isolator-
friendly loading and unloading system freeze dryer.

Robotic handling
Eliminates human intervention and reduces risk to products.

Operator friendly
Ergonomically designed with operator and interventions considered to reduce risk.

3 formats on 1 platform
Processing of syringes, vials and cartridges.

… and many more

Fully automated processes
The fully automated line execution eliminates the need for human intervention into the filling line.

Infeed transfer options
The groninger No-Touch-Transfer and the Franz Ziel H2O2 chamber provide safe and simple transfers of RTU containers into the isolator.

Smart fill technology
gronigner offers a wide range of features to eliminate product waste during priming, production and run-empty phases.

Quick Connect philosophy
Designed for tool-less change over and minimal format parts.

Freeze drying capabilities
The Martin Christ portfolio offers state of the art freeze dryers with a wide range of PAT-Tools and SCADA-System LPCplus.

Zone concepts
With individually controlled isolator modules, different requirements for various OEB and BSL levels can be met.

Complete Downstream Equipment
groninger offers a comprehense downstream equipment for object processing, from plunger rod insertion to safety device assembly and labelling.

Flexibility
Capable of processing nested vials, syringes and cartridges in one line configuration and bulk vials, trayed vials and eye drop container by exchanging machine trolleys.