The CFDA on drug standards continues to improve, making pharmaceutical companies more stringent requirements for Filling Machines. Filling accuracy is the first element to show the performance of the Filling Machine, which directly affects the quality of drugs. The stability of filling accuracy is an important guarantee of producing qualified drugs. For the filling and corking machine in the ceramic pump filling system, there is the phenomenon of unstable filling volume, which can be analyzed from the mechanical structure and electrical control of the two aspects of the reasons, and put forward measures to solve.

I. Cause analysis.

1. Mechanical structure.

The mechanical structure of the filling system is as follows.

(1) Liquid dispensing system: used to transfer the prepared liquid to the dispenser or liquid bag.

(2) Dispenser: buffer dispensing integrated tank and closed dispenser.

(3) Filling part is mainly composed of a rotary valve motor and driving unit, multiple sets of filling motor and driving units, transmission gear, roller screw, ceramic pump, etc.

(4) Needle holder structure: used to track and position bottles for the corresponding filling.

2. Electrical control.

The filling is carried out by the absolute position control mode of the servo motor, which can be precisely positioned. When the servo motor does not reach the specified position, the servo motor will alarm and stop the filling and equipment; at the same time, the control of the rotary valve is the same as the control of the filling pump; there is also the control of the needle holder reciprocating and lifting, all the above three points belong to the electrical control.

II. Countermeasures.

From the above, the Filling Machine is generally inaccurate filling volume is due to dripping or bubbles, and the main reasons for dripping and bubbles and countermeasures are as follows.

(1) sterilization apparatus did not choose non-metallic materials, sterilization, the pump rod and metal material contact, the pump rod on the sticky metal materials, easy to cause the pump rod wear, poor airtightness, filling process bubbles.

The solution is to try to use special sterilization apparatus.

(2) When the pump is installed, the pump body and the pump rod are mixed, and the pump gap is not matched, which will easily cause the pump rod to wear, poor air tightness, and bubbles during the filling process.

The solution is to mark the pump body and pump rod and not mix them.

(3) the installation position of the reservoir, dispenser, ceramic pump, and needle holder, the installation position of the buffer tank relative to the installation position of the ceramic pump height difference is too large, the ceramic pump by the pressure of the liquid is too large, easy to cause the filling needle drip.

The solution is to minimize the height difference between the installation position of each component. If it cannot be reduced, add a buffer device between the buffer tank and the pump.

(4) If the silicone tube, dispenser, and ceramic pump coupling are not tightened will also produce bubbles or dripping.

The solution is to add a check before each start-up and immediately replace the connector or silicone tube if the above situation exists.

(5) The connection between the ceramic pump and the rotary valve is shaking too much, or the verticality of the pump is a problem, resulting in dripping.

The solution is to increase the number of tests each time the pump is installed, and if the connection live knot wobbles too much, it is recommended to replace it.

(6) Filling servo motor itself is not rigid enough, resulting in filling late ceramic pump has a slight wobble, resulting in dripping.

The solution is to manually adjust the rigidity of the servo motor until it is suitable.

(7) Filling speed is too fast, resulting in too much pressure on the silicone tube and dripping.

The solution is to reduce the filling speed, change the acceleration and deceleration of the filling pump or replace the silicone tube with a thicker wall.

(8) The needle holder and the length of the silicone tube are too long and cause too much shaking, resulting in dripping.

The solution is to tighten the needle holder, and if it cannot be tightened, replace the fasteners, reduce the length of the silicone tube as much as possible, and if there is still shaking, add a fastener in the middle.

(9) Due to the return suction amount being set too large, resulting in the liquid being back into the silicone tube, when the next time to carry out filling easy to produces bubbles in the needle mouth, thus affecting the loading volume (mainly small-size products).

The solution is to add different formulas of return suction volume according to different drug processes and call different formulas of return suction volume in different situations.

These are the reasons and countermeasures for the unstable filling volume of the Filling Machine. If you need more detailed information, welcome to contact us!