How are ampoule tips removed after melting?

Motorized mechanical draw-off pinchers gently pull and discard heated tip waste into an isolated bin.

What warranty applies to this machine?

Machines are supplied with a 12-month warranty from commissioning covering manufacturing defects, with wear parts and tooling excluded. Extended cover is available under an annual maintenance contract, which also fixes response times for breakdown attendance.

What documentation is supplied at handover?

Handover includes the operation and maintenance manual, electrical and pneumatic schematics, the spare parts list with part numbers, material test certificates for contact parts, sensor calibration certificates and the completed qualification dossier.

How is fill volume accuracy maintained?

Volume is set by servo-driven pumps and verified at start-up and at defined intervals through the run. Machines can be specified with 100% inline checkweighing, which rejects out-of-tolerance units and records each weight against the batch.

Is the machine suitable for aseptic filling?

Aseptic configurations are supplied for installation under Grade A protection, with RABS or isolator interfaces, sterilisable product path and steam-in-place connections. The qualification package addresses EU-GMP Annex 1 expectations.

How are changeover and cleaning handled between products?

The product path is designed for clean-in-place and steam-in-place where the process requires it. Where a full CIP is not justified, the wetted assemblies are removable as a set for offline cleaning and autoclaving.

AFC-120 Automatic Ampoule Filling & Flame Sealing Monoblock

Name: AFC-120 Automatic Ampoule Filling & Flame Sealing Monoblock
Brand: GentlemanPharmed
Availability: InStock

Aseptic ampoule filling and hermetic flame sealing monoblock with oxygen-gas burner heads and pre/post nitrogen flushing for 1 mL to 20 mL ampoules.

Call Us

Overview

About the AFC-120 Automatic Ampoule Filling & Flame Sealing Monoblock

The **AFC-120 Ampoule Filling & Sealing Monoblock** is designed for sterile injectable solutions packaged in open-funnel or closed-stem glass ampoules. Featuring walking beam transport, valveless ceramic pumps, dual nitrogen flush stations, and precision oxy-hydrogen burner jets, the AFC-120 creates hermetic dome seals with zero soot contamination.

Oxy-Hydrogen Clean Flame Sealing: Produces clean, carbon-free flame ensuring pristine, soot-free glass ampoule tips.

Servo-Driven Volumetric Dosing: Fill volume is set electronically and held across the run, removing the drift associated with mechanically set cam systems.

Drainable, Sanitary Product Path: The wetted path is fully drainable with sanitary fittings throughout, supporting clean-in-place and, where specified, steam-in-place.

Specifications

Technical Specifications

Technical specifications for the AFC-120 Automatic Ampoule Filling & Flame Sealing Monoblock
Ampoule Range	1 mL to 20 mL
Filling Accuracy	± 0.5%
Gas Mixture	Oxygen + Natural Gas or Hydrogen

* Specifications may vary by model. Contact us for exact configuration.

Validation Support

Full IQ/OQ/PQ documentation packages available. Our validation team works with your QA department to ensure regulatory acceptance.

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)

Compliance Standards

Built and tested to international pharmaceutical manufacturing standards.

WHO-GMPISO 9001CE MarkedCDSCO

See it in Action

Video Demonstration

Machine demonstration video

AFC-120 Automatic Ampoule Filling & Flame Sealing Monoblock — Product Brochure

Technical specs, dimensions & ordering guide · PDF

Download Brochure

Gallery

Product Gallery

FAQ

Product FAQs

Common questions about our pharmaceutical machinery.

Ready to Order?

Get a custom quote, technical specifications, and delivery timeline from our experts.

+91 98311 97931

About the AFC-120 Automatic Ampoule Filling & Flame Sealing Monoblock

Ampoule Range

1 mL to 20 mL

Filling Accuracy

± 0.5%

Gas Mixture

Oxygen + Natural Gas or Hydrogen