Screw assembly machine

I. Uses

It is suitable for the aseptic filling and stoppering of sterile powder for injection into vials, plastic bottles, and other pharmaceutical glass containers.

II. Characteristics

1. Equipped with full‑servo drive, it features automatic rejection of inverted bottles, no filling when bottles are missing, automatic alarm and shutdown in case of stopper shortage, and automatic counting.

2. The entire system is equipped with an industrial tablet PC, enabling real-time printing of all data and allowing data to be copied and stored.

3. Equipped with an onboard O-Rabs system to achieve complete isolation between the operational and non-operational areas;

4. The dispensing head features a one‑step disassembly function, facilitating cleaning, installation, disinfection, and sterilization.

5. Automatic powder‑collection mechanism that captures airborne powder with a collection efficiency of over 98%, preventing the powder from adhering to the exterior of the vials after dispensing.

6. Fully automatic sampling function with servo‑driven sampling, ensuring accurate and reliable results. It can also be equipped with fully automatic weighing or weigh‑while‑sampling.

7. Fully automatic powder‑feeding function, driven by all‑servo control, enabling automatic loading from the raw‑powder hopper, automatic drum‑turning mechanism, automatic alignment, and electric butterfly valve opening. This reduces labor intensity, minimizes manual intervention, and enhances product quality.

8. The stopper bucket features automatic lifting, automatic flipping, and automated stopper feeding, minimizing manual intervention and ensuring stable production.

9. Based on the customer’s powder characteristics, we customize screws of different specifications, achieving filling‑weight accuracy that exceeds that of comparable products.

10. The filling machine is divided into six zones: a bottle‑sorting buffer zone, a filling zone, a stoppering zone, a stoppering buffer zone, a raw‑material buffer zone, and a feeding zone. Each production area is segregated from its corresponding maintenance area to minimize the risk of cross‑contamination. The critical filling zones are maintained at negative pressure to prevent drug leakage.

11. The standard components adopt a modular design, making them easy to replace; all standard components can be swapped out by hand.

12. All sensors are installed using a custom‑designed, concealed stainless steel mounting kit, with no wiring or conduit visible on the equipment baseplate. The equipment is neat, clean, and easy to maintain.

13. In the tail‑material dispensing mode, during the final dispensing step, the number of steps driven by the dispenser’s servo motor is automatically increased based on the powder level, ensuring precise dispensing of the tail material.

14. The entire machine adopts a formula‑based operating mode, allowing users to select and configure the dispensing configuration according to their requirements: single‑head dispensing, dual‑head dispensing, triple‑head dispensing, quad‑head dispensing, as well as two‑stage or three‑stage dispensing, among others.

15. For powders with poor flowability, the discharge butterfly valve on the raw material hopper is a pneumatically actuated vibrating butterfly valve to prevent powder bridging and ensure smooth discharge.

16. Depending on the powder’s flowability, crystal morphology, specific gravity, and other physical properties, the material of the discharge funnel and nozzle can be selected from 316L stainless steel, fully imported POM, ceramic, or imported PEEK (polyether ether ketone), with a minimum fill weight as low as 15 mg.

17. Based on the customer’s specified fill volume, product batch, and product model, formulas can be configured arbitrarily and retrieved as needed during production.

18. Patent‑pending online nitrogen‑filling system, with residual oxygen levels below 2%.

19. SCADA data acquisition and recording system; audit trail functionality.

20. Fully compliant with the EU’s GAMP 5 and FDA 21 CFR Part 11 requirements.

21. Isolators can be configured according to customer requirements.