Filling of semi-solids in ready-to-fill syringes

Reliable filling of pre-filled syringes with highly viscous fluids and pastes

Dosing syringes are an important option for the precise and clean application of pharmaceutical substances. However, the thin cylindrical cavities quickly become a challenge, especially when filling ready-to-fill syringes with highly viscous materials or semi-solids. Nevertheless, absolutely precise filling of the syringe is a must. Conventional filling technologies in the pharmaceutical industry often reach their limits when it comes to semi-solid products.

ViscoTec has set itself the task of being able to fill a wide variety of products with just one dosing system. From watery to highly viscous, shear sensitive, abrasive, aggressive or toxic. This includes all viscous pharmaceutical or medical technology products and so-called semi-solids with or without highly effective substances: E.g. dermal fillers such as hyaluronic acid or depot medication drugs made of liposomes, filled with abrasive solids such as hydroxyapatite or shear-sensitive active ingredient crystals.

Flexible but high-precision filling of syringes

The ViscoTec endless piston principle enables a precise, gentle, and pulsation-free product flow. The dispensers have a flow rate of 0.2 to 700 ml / min and fill flexibly e.g. Luer Lock or Luer Slip syringes from 0.2 ml to 50 ml with a filling accuracy of +/- 1 %. The net dosing time can be less than one second per syringe. A possible overfilling but also underfilling, especially with self-medication of standard syringes, is therefore eliminated.

Even small and very small batches with frequent product changes are possible thanks to the easy cleanability of the GMP-compliant Hygienic Dispensers. Cleaning is performed either by COP (Cleaning out of Place) or CIP (Cleaning in Place). Components in contact with the product can be autoclaved.

The special design of the filling pumps enables a programmable suck-back, which in turn ensures a defined thread break and therefore prevents unwanted dripping or thread pulling. To do this, the direction of rotation of the dispenser is changed and the dosing material is sucked-back into the dosing needle in a defined manner. The suck-back function can also be used for materials with difficult thread breakage. Dosing quantity, speed and acceleration can be individually adjusted according to the requirements of the product. The viscosity does not affect the dosing performance.

Syringe filling application example:

For one customer, for example, syringes had to be filled to meet GMP conditions: Each 1 ml ointment with a dynamic viscosity of 160,000 mPas. In addition, it was also a requirement to implement this without air bubbles and with a tolerance of +/- 1 %. Due to the good preliminary results of dosing tests at the in-house technical center, the customer decided to use a ViscoTec Hygienic Dispenser 3VPHD8. The syringe is filled through the cone. Due to the viscosity of the material and the small opening, high dosing pressures occur here, which - as already mentioned - can be handled well due to the pressure stability of the endless piston technology. At the end of filling, the material is withdrawn from the syringe cone to keep it clean. During the first tests for the application, exceptionally good repeatability of 99.7 % was achieved in addition to dosing tolerances of less than +/-0.5 %. This accuracy was also confirmed later during production.