Wuxi Griffin’s main focus and expertise is aseptic fill and finish of sterile pharmaceutical injectables in vials and ampoules. We offer fill and finish manufacturing from clinical trials to commercial scale up that will meet global GMP requirements. Our batch sizes range from 2 to 150 liters and future 500 liters. At Wuxi Griffin we offer complete sterile fill and finish services for liquid products using isolator technology and RABS technology with terminal sterilization.
As your favored contract manufacturing partner, we offer customized fill and finish services to meet your needs. We look forward to leveraging our expertise and experience at any stage of the development and production process. In addition, we adopt a transparent approach with our partners. As a result, you will maintain in control over the process and your products, whilst having complete project flexibility.
Filling Capabilities
Aseptic Fill & Finish Contract Manufacturing Services
- Three filling suites
- two aseptic
- one terminal sterilization by superheated water
- Flexible filling volume
- Batch sizes ranging from 120 – 10 000 vials
- Batch sizes ranging up to 75 000 ampoules
- Manual secondary packaging
- Transparency and traceability
- High flexibility
Commercial Manufacturing
Our GMP 2550m2 / 27450 sqft facility has a commercial fill & finish manufacturing capacity. We offer great flexibility in our manufacturing with our three filling suites and our integrated resources and technology. Furthermore, with a reliable business infrastructure on site we help you to minimize your risks. We deliver promised results from clinical manufacturing through to global market supply. All of our fill finish manufacturing operations also comply to GMP regulations.
Project Management
We are aware that every project at Wuxi Griffin is unique and every client has its individual needs. Our approach is to help you reach your goal by offering customized solutions to every project. Our experienced project management team is here to support you in every aspect of the project lifecycle.
We have experience in managing a wide variety of projects from working with a broad client base ranging from big pharmaceuticals to smaller specialty pharmaceuticals. As a result, we put great emphasis on effective communication in order to make accurate and timely decisions. In addition, by listening to your needs we are also able to tailor solutions to your individual project.
With every project, we offer a project planning and management process that include an assignment of a professional team, communication coordination, an action plan and time plan, program tracking as well as continuous regulatory support. Our aim is simply to take care of your project with minimal confusion and maximum productivity and to promised results.
We will assist you in your project from start to finish. Whether you start from formulation, clinical manufacturing or commercial manufacturing we are here for you.
Formulation
Wuxi Griffin advises on the formulation process, as this is of great importance to the safety and reliability of a drug. We therefore formulate your drug according to your established specifications with greatest care. To minimize risks of contamination in the filling process we use single use system. However, in ampoule filling, we use traditional formulation system as well as single use system.
All of the drugs we formulate will be regulatorily compliant, scalable and commercializable for our customers.
Final Product Sterilization
We perform the following sterilization method:
> Superheated water
We carry out the terminal sterilization stage with utmost accuracy to guarantee the sterilization of the final drug. Ultimately, this means that the final filled ampoule is free from microbial contamination. We evaluate the heat stability of the materials before deciding if terminal sterilization process is accurate for your products.
Packaging And Labeling
Wuxi Griffin offers exhaustive packaging and labeling services. We assist you in the selection of primary to secondary packaging that fits your specific drug formulation. Our customized packaging services will ensure your products are safe.
We use the below applied methods for tests of packaging:
> Container closure integrity
> Seat of crimping cap and related stopper compression (e. g. residual seal force)
> Correctness of labeling
> Primary and secondary packing check for broken packaging or other nonconformances
Visual Inspection
We carry out a 100% visual inspection process on each of our final vials and ampoules. Those that do not meet specifications are rejected. Our inspections are carried out manually and most importantly follow a comprehensive and well-established procedure. In short, visual inspections serve as a vital step in assuring the safety of the filled product.