Detailed Description
Introduction:
The vial filling production line is a high-efficient, accurate, and safe filling solution widely used in pharmaceutical, biotechnology, food, and cosmetics fields. With mature technology and widespread application, it has passed long-term market testing and is highly recognized by the industry.
Why Choose This System?
- Complete Line: Consists of a vertical ultrasonic bottle washing machine, sterilization tunnel oven, vial filling and stoppering machine, and capping machine.
- High Automation: Automatically completes loading, washing, drying, filling, stoppering, and capping with minimal manual intervention.
- Compatibility: Applicable for 2ml to 100ml vials by replacing simple change parts.
- Regulatory Compliance: Designed according to EUGMP, FDA, and cGMP standards. Parts in contact with products are made of 316L stainless steel.
- Safety: Audit tracking system with 4-level user access management.
I. Ultrasonic Vertical Bottle Washing Machine
Adopted for cleaning vials, oral liquid bottles, and ampoules. Uses ultrasonic cleaning combined with alternate filtered water and air spraying.
| Capacity | ≥6000 pcs/h (10ml vials) |
| WFI consumption | About 0.5-0.7m³/h |
| Vial breakage rate | <0.05% |
II. Hot Air Circulation Sterilization Tunnel Oven
Uses hot air laminar flow to sterilize vials at high temperatures (up to 350°C). Efficient, energy-saving, and equipped with HEPA filters.
| Sterilization temperature | 280ºC-350ºC, adjustable |
| Vial breakage rate | <0.01% |
| Outlet temperature | ≤ Room Temperature + 15ºC |
III. Vial Filling and Stoppering Machine
Core equipment featuring high-precision servo control. Includes O-rabs system, Class A laminar flow, and high filling accuracy pumps.
| Capacity | ≥7200pcs/h (2ml vials) |
| Filling Error | ≤±1% (>2ml) |
| Stoppering rate | ≥99.9% |
IV. Capping Machine
Final sealing process using rotary tracking capping. Features "no bottle no capping" and "no stopper no capping" sensors.
| Capping qualified rate | ≥99.9% |
| Vial breakage rate | <0.05% |
Frequently Asked Questions
Q1: What sizes of vials can this production line handle?
A: The system is highly compatible and can handle vials ranging from 2ml to 100ml by replacing specific change parts.
Q2: What is the filling accuracy of the machine?
A: For filling volumes over 2ml, the error is ≤±1%. For volumes between 1ml-2ml, it is ≤±1.5%.
Q3: Does the equipment comply with international pharmaceutical standards?
A: Yes, the design refers to international standards including EUGMP, FDA, and cGMP regulations.
Q4: What materials are used for the parts that touch the medicine?
A: All parts in contact with products are made of stainless steel 316L or medical-grade silica gel to prevent contamination.
Q5: Is the sterilization oven energy efficient?
A: Yes, the oven uses a hot air circulation heating mode which ensures uniform internal temperature while being highly efficient and energy-saving.
Q6: What happens if there is a "no bottle" situation during filling?
A: The machine is equipped with sensors for "no bottle no filling" and "no bottle no capping" to ensure zero waste and maintain production stability.