Aseptic Fill and Finish
HALIX is specialized in aseptic fill and finish and lyophilization of drug product manufacturing from clinical to commercial scale
Fill and Finish
Fill and finish is the final manufacturing step in creating an aseptic drug product. Aseptic liquid filling requires highly technical driven processes to ensure a sterile and safe product is administered to the patient.
We provide GMP certified production capabilities with an automated filling line, processing over a million vials per year. Viral biological products for which BSL2 conditions are required, can be filled manually. Fill and finish activities of your drug product can be complemented with customized labelling and packaging.
Fill and freeze drying is often applied as a dehydration process to extend the shelf life and stability of the product. HALIX offers lyophilization services from the development of a lyophilization cycle up to industrial lyophilization. The lyophilization cycle development is performed freeze drying in a small scale pilot dryer of 0.5 m2 plate, or in our industrial lyophilizer of 5.2 m2 plate.
In the case of very small batches we can also perform manual filling for drug product manufacturing from clinical to commercial scale.
The HALIX service package offers terminal sterilization including 100% visual inspection of the vials using polarized light, labelling and packaging, and QP batch certification. Depending on our client’s situation and preferences we offer a highly flexible package of services and adapt them individually to your requirements.