Nowadays almost 50% of the injectable products that are in clinical trials or are approved for marketing, are freeze dried products. Main reasons are the advantages in stability, easy handling during shipment and an adequate solution to cold chain problems associated with liquid products.
During fill-finish manufacturing of freeze dried products, the vials filling process is a critical unit operation. One of the major risks during vials filling is the so called “splashing”.
SPLASHING
Splashing is a common challenge with high speed vials filling. The cause of the phenomenon is higher solution velocity of the product in the vial, due to high vials fill speed. Splashing is also an undesirable phenomenon as it may result in container-closure integrity (CCI) implications, product spills on the fill line, and cosmetic defect implication for the freeze dried final cake. Splashing also increases the adsorption of product on the container surface: this may affect with spots and streaks on the vial.
During large-scale manufacturing of a freeze dried product, the vials filling of the drug substance can be carried out using different types of vials filling machines. Depending on the vials filling line setup and design, product splashing may occur, and it can lead to the presence of residual product around the vial neck. Technically speaking there are different aspects that can be considered in order to avoid wave effect and splash to the vial’s walls.
i-Dositecno has been tackling this matter and give us 3 main scenarios to address it:
the vials filling needle may not be centered properly to fill the product at the center of the vial or the filling needle may drip after filling into a vial is complete.
Control the vials filling speed reducing last percentage of filling by using different nozzles with independent servo control.
Control the movement of the vial, by means of an adjustable walking beam unit, able to smooth the vial movement when required, in order to avoid wave inside the vial.
i-Dositecno with a rigorous quality system is always involved in continuous improvement and excellence in order to achieve the highest quality and safety standards.