Supporting Services

Eurofins Sinensis 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 Sinensis, guaranteeing:

  • clear communication (single-point-of-contact)
  • confidentiality
  • flexibility
     

Adding value to your full development process

The services of Eurofins Sinensis 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 Sinensis is able to work with primary packaging materials, raw materials and excipients delivered by clients.

If requested, Eurofins Sinensis 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 Sinensis. This ensures a homogeneous batch distribution during the Fill & Finish process.

Extractables and leachables testing

► More information on this service

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 Sinensis 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

► More information on method development and validation
 

Eurofins Sinensis 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.

Stability studies

► More information on this service

Design and performance of your stability studies, or development and validation of stability indicating methods. Having all the facilities internally available, Eurofins Sinensis is your ideal partner. 

Eurofins Sinensis 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 Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
  • Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
  • Flexible approach. Eurofins Sinensis 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.

 


Questions? Call us now

+31 (0)71 524 4080