Aseptic Fill & Finish Service
Aseptic Fill & Finish Service
Your partner for the finished drug product
Diatheva provides aseptic Fill and Finish, which is the final, critical step in the GMP manufacturing of biopharmaceutical products.
This is a specialized process, involving high developed techniques that will ensure that the product is sterile and ready for the clinical dosing.
Why us?
Experience
We have more than 20 years of experience in GMP manufacturing to the pharma and biotech companies.
Quality
We are GMP authorized for formulation & filling (Human medicinal products) by AIFA *
Aseptically filled GMP-certified drug products can be used for clinical trials or for commercial purpose.
Flexibility
We are able to support you at any stage of your GMP production.
* Our services meet the standards of European regulatory agency (EMA)
The complete Fill and Finish service chain, authorized by AIFA * , for human drug product includes: formulation, semiautomatic aseptic fill and finish, visual inspection, product labelling, QP certification.
Our Fill & Finish Capabilities:
- Batch size range: from 500 to 3000 vials
- Range volumes: from 1mL to 30mL
- Validated for 2R, 6R vials with capability to expand to 50R
- Semiautomatic filling machine
- 100% headspace analysis, manual and visual inspection options
- Comprehensive pharmaceutical support including QA/QC and regulatory