Description

Engineered for Sterile Pharmaceutical Production

The A-50 Automatic Monoblock is a turnkey solution for the demanding requirements of aseptic fill-and-finish operations for ampoules. Its robust, closed design is constructed with high-grade stainless steel (AISI 304/316L) and features that meet stringent Good Manufacturing Practice (GMP) guidelines. This machine is indispensable for manufacturers of injectable drugs, vaccines, diagnostic reagents, and biotech solutions who cannot compromise on sterility and accuracy.

Key Features/Benefits

• Closed GMP-Compliant Design: Protects the product from environmental contamination, ensuring aseptic conditions throughout the filling and sealing process.

• High-Precision Filling System: Achieves accurate dosing with minimal deviation, critical for valuable pharmaceuticals, reducing product waste.

• Hermetic Sealing Technology: Creates a flawless, tamper-evident seal on the glass ampoule neck, ensuring product sterility and long shelf life.

• Nitrogen Purging Option: Integrated system for inert gas purging before and after filling to prevent oxidation of sensitive products.

• «No Ampoule, No Fill» Technology: Sensors prevent product discharge unless an ampoule is present, eliminating waste and maintaining machine cleanliness.

Technical Specifications & Performance

• Machine Type: Automatic Ampoule Filling & Sealing Monoblock (Closed Design).

• Compliance: Built to GMP standards.

• Filling System: Peristaltic or piston dosing systems for high accuracy (e.g., ±0.5%).

• Production Speed: Ranging from approx. 2,000 to 3,000 ampoules per hour, depending on configuration.

• Ampoule Compatibility: Handles standard glass ampoules from 1ml to 20ml or more.

• Control System: Advanced PLC with user-friendly Touchscreen HMI for recipe management, data logging, and parameter control.

Advantages of a Closed GMP Design
The closed configuration of the A-50 provides critical benefits for pharmaceutical manufacturing:

• Contamination Control: Significantly reduces the risk of airborne contaminants and particulate matter entering the critical filling zone.

• Process Integrity: Enables a controlled environment that is easier to validate and monitor, supporting regulatory compliance.

• Operator Safety: Provides a physical barrier between the operator and the moving parts and product, enhancing workplace safety.

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