Beeld: Eurofins

Pharmaceutical aseptic filling is a crucial step in pharmaceutical drug development. This process involves the precise filling of pharmaceutical products into designated containers, executed under strict sterile conditions, to produce pharmaceutical end products that are sterile and safe for administration to the patients.

Within the manufacturing department of Eurofins BioPharma Product Testing Netherlands, we have extensive expertise in conducting small-scale aseptic filling projects for various types of pharmaceutical products from small molecules to biologicals, and radiopharmaceuticals. Our operations strictly adhere to Good Manufacturing Practices (GMP), ensuring the highest standards of quality and safety.

At Eurofins BioPharma Product Testing Netherlands, our validated manual fill & finish process setups are designed with a focus on flexibility. This flexibility allows us to provide customised aseptic filling solutions for various types of compounds, primary packaging systems, batch sizes, and fill volumes, to meet unique client requirements. This level of customisation is especially crucial for companies with products in the pre-clinical phase and phase 1 clinical trials, where there are uncertainties in the final process set-ups and the behavior of the final product within these set-ups. To establish the final process set-ups, close collaboration with our clients is crucial to meet their requirements. Other key considerations during this process are risk management of the entire project, considering aspects such as reliability of raw material suppliers, timelines of the validation of methods, and stability data. But also, contract management, including setting up a Quality Assurance Agreement (QAA) and a Master Service Agreement (MSA) with all parties and key stakeholders involved.

Another important facet throughout the entire process of aseptic filling is rigorous testing. Starting from testing of the raw materials used in production. But most important, the performance of an aseptic process simulation to validate the aseptic filling process. Also, during the aseptic fill & finish pre-filtration bioburden testing needs to be performed, followed by filter integrity testing after filling to confirm the aseptic filtration of the product. Finally, release testing needs to be performed, including osmolality testing, pH testing, purity testing, sterility testing, endotoxin testing, container closure testing (CCIT), and other product specific testing, to release the final product.

Through proper planning and active engagement with stakeholders, Eurofins ensures the safety and timely release of the finished product to deliver at the client site.

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Author: Marianne Budde, Business Unit Manager Eurofins PROXY Manufacturing

Company: Eurofins BioPharma Product Testing Netherlands,