Eurofins BioPharma Product Testing Netherlands offers various additional chemical, microbiological and ancillary services to complete the service portfolio of the manufacturing department. Clients have the opportunity to outsource their entire project to Eurofins BioPharma Product Testing Netherlands, guaranteeing:
- clear communication (single-point-of-contact)
Adding value to your full development process
The services of Eurofins BioPharma Product Testing Netherlands are not limited to small scale GMP manufacturing. Read more on our additional services below or in the menu at the left. We strive to be your partner in the entire process, so if your project requires additional service or customization please contact us to discuss the possibilities.
Use of client specific materials
Mixing validation and holding time studies
Extractables and leachables testing ► Read more
Method validation and release testing ► Read more
Stability studies ► Read more
Use client specific materials
With a flexible approach, Eurofins BioPharma Product Testing Netherlands is able to work with primary packaging materials, raw materials and excipients delivered by clients.
If requested, Eurofins BioPharma Product Testing Netherlands can purchase and release all materials for the manufacturing activities. All materials will be EP and USP quality materials. Batches of raw materials and excipients will be tested in house and according to the selected pharmacopeia. The batches will be sampled from reference samples and stored conform current regulations. Contact us for more information.
Mixing validation and holding time studies
To set and validate process parameters for the compounding and sterile filtration phase, a mixing validation and holding time study can be performed by Eurofins BioPharma Product Testing Netherlands. This ensures a homogeneous batch distribution during the Fill & Finish process.
Extractables and leachables testing
All primary packaging components contain constituents such as impurities, contaminants and degredants that have potential to accumulate in the end product. These constituents are typically referred to as extractables and leachables.
Eurofins BioPharma Product Testing Netherlands can perform extractable and leachable studies. GC-MS and LC-MS systems are available to perform these studies up to identification and quantification with the use of the NIST database.
Method validation and release testing
Eurofins BioPharma Product Testing Netherlands can develop and validate the required GMP compliant test methods for in process controls during your manufacturing campaign, as well as the release testing for your batch release.
Our manufacturing department is complemented by a well-equipped chemical and microbiological Quality Control (QC) testing facility. The Quality Assurance (QA) department oversees all documentation during the process and when required a QP is internally available for QP-release.
Design and performance of your stability studies, or development and validation of stability indicating methods. Having all the facilities internally available, Eurofins BioPharma Product Testing Netherlands is your ideal partner.
Eurofins BioPharma Product Testing Netherlands can lead the process from study design to storage, monitoring, analytical testing and documentation. Customers are offered a complete range of storage conditions in climatic chambers, refrigerators and freezers. The stability units have operational back-ups and are fully controlled with 24/7 monitoring and alert systems, 21 CFR part 11 compliant. More information on storage conditions.
- All services available internally. As Eurofins BioPharma Product Testing Netherlands is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertises within the same organization, allowing clear and reliable communication.
- Flexible approach. Eurofins BioPharma Product Testing Netherlands has the flexibility to provide you with materials, as well as working with the materials that you prefer. You require a custom approach? Feel free to discuss your needs so that we can provide a suitable solution.