Ampoule wire-drawing and sealing machine
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- Product Description
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I. Uses
Suitable for filling and stoppering medicinal glass containers such as vials and plastic bottles.
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. It complies with the latest GMP requirements as well as EU and FDA standards.
2. Control is implemented using a programmable logic controller (PLC).
3. A zone-based laminar flow hood is employed, with effective isolation in the equipment’s central area to prevent cross-contamination.
4. The needle‑filling lift mechanism employs a servo‑driven lifting system, reducing filling vibration, preventing liquid splashing, and ensuring a high pass rate for filament‑forming tests.
5. A dedicated locating pin is designed for vials of different specifications; when changing to a new specification, simply loosen the nut on the top of the stopper‑holding plate and insert the locating pin, thereby reducing mold‑change time.
6. The filling needle lift mechanism and the nitrogen‑charging needle are designed as independent units, minimizing vibration during filling and preventing any dripping.
7. Adopts a flexible bottle‑contact structure, ensuring more precise bottle positioning and preventing product adhesion to the container walls during filling.
8. Ceramic bearings are used in special areas;
9. The entire machine employs a recipe‑based operating mode, allowing users to select and invoke recipes in a user‑friendly manner according to their specific requirements.
10. Equipped with a high-precision pump for filling, ensuring excellent filling accuracy. Cleaning, disassembly, and installation are quick and convenient.
11. Nitrogen purging is performed throughout the entire process (pre‑purge, post‑purge, preheating purge, and wire‑drawing purge), with residual oxygen levels below 1%.
12. The entire unit features a balcony‑style design with an elevated platform, offering a clean, aesthetically pleasing surface that is easy to clean. All sensor components are mounted using stainless steel brackets, and no wiring is exposed on the worktop.
13. All set nuts are specially designed梅花型 (plum-blossom‑type) nuts, making it easy to replace standard components and enabling tool‑free replacement of all part sizes.
14. Based on the customer’s specified fill volume, product batch, and product model, formulas can be configured arbitrarily and recalled as needed during production.
15. Utilizing an industrial PC, the entire system can implement a SCADA data acquisition and recording system, along with audit trail functionality.
16. Fully compliant with the EU’s GAMP 5 and FDA 21 CFR Part 11 requirements.
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