Open Mouth Ampoule Filler Sealer

Q: What is an Open Mouth Ampoule Filler Sealer?

An Open Mouth Ampoule Filler Sealer is a fully automatic monobloc machine designed for filling and flame sealing of open mouth glass ampoules (Type B & Type C). It is widely used for sterile liquid injectables where the ampoule neck is already open. The machine integrates nitrogen flushing (pre- and post-filling), precise volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. It is ideal for pharmaceutical, biotech, and veterinary injectable production and complies with cGMP, USFDA, and WHO standards.

Q: What are the available models and production capacities of the Open Mouth Ampoule Filler Sealer?

We offer four standard models: AFS-1 (Single Head) : Up to 25 ampoules per minute (~1,500 per hour) AFS-2 (Two Heads) : Up to 50 ampoules per minute AFS-4 (Four Heads) : Up to 100 ampoules per minute (~6,000 per hour) AFS-8 (Eight Heads) : Up to 200 ampoules per minute (~12,000 per hour) Custom high-speed models are available up to 36,000 ampoules per hour. The machine supports ampoule sizes from 1ml to 30ml with filling volumes from 0.5ml to 25ml and filling accuracy of ±1% .

Q: How does the Open Mouth Ampoule Filler Sealer work?

The machine operates on the slant traveling principle for smooth ampoule movement. The process flow is: Sterilized open mouth ampoules are loaded into the hopper Nitrogen pre-flushing to remove oxygen Precise filling using piston pumps with neck centering Nitrogen post-flushing Neck pre-warming Flame sealing with accurately controlled LPG + Oxygen burners Safety systems like “No Ampoule – No Filling” and “No Ampoule – No Seal” ensure zero wastage. Sealed ampoules are collected automatically on a tray.

Q: Is Open Mouth Ampoule Filler Sealer cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Open Mouth Ampoule Filler Sealer complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

Q: Does Adinath International provide Open Mouth Ampoule Filler Sealer internationally?

Yes, Adinath International Open Mouth Ampoule Filler Sealer export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure .

Description

Open Mouth Ampoule Filler Sealer is a specialized piece of pharmaceutical equipment designed for the precise filling and sealing of open-mouth glass ampoules, typically used for packaging liquid injectable drugs, cosmetics, agro-insecticides, veterinary medicines, and other chemicals. These machines are engineered to ensure sterility, accuracy, and compliance with cGMP (current Good Manufacturing Practices) standards, making them essential in industries requiring high-quality, contamination-free packaging. Below is a detailed description of the machine, its operation, and key features based on available information: Open Mouth Ampoule Filler Sealer Machines are automated or semi-automated systems designed to handle open-mouth glass ampoules (typically Type B or Type C) ranging in size from 1ml to 30ml. These machines perform a sequence of operations including ampoule loading, nitrogen purging, liquid filling, pre-heating, and sealing, all on a single platform (monobloc design). They are built to accommodate variations in ampoule neck dimensions, thickness, and ovality, ensuring precise filling and hermetic sealing to prevent contamination.

Open Mouth Ampoule Filler Sealer Machine operates on the principle of slant traveling, where ampoules are transported at an inclined angle during filling and sealing processes to optimize handling and ensure uniform operations. They are constructed with high-quality materials, such as Stainless Steel 316L for contact parts and Stainless Steel 304 for non-contact parts, to meet cGMP requirements and ensure durability and sterility. Open Mouth Ampoule Filling Machines are critical for the efficient, sterile, and precise filling and sealing of glass ampoules in pharmaceutical, biotech, cosmetic, and other industries. With advanced features like nitrogen flushing, multiple filling mechanisms, and high-speed outputs, these machines ensure product safety and compliance with stringent regulatory standards.

Salient Features of Open Mouth Ampoule Filler Sealer

Compact model as per cGMP standard.
Higher output up to 12000 Ampoules per hour.
Full accessibility allows easy maintenance.
Flow Meters for regulating flames easily.
“No Ampoule – No Filling” system.
Machine equipped with pre-warming station.

Ampoule neck centering during gas flushing and filling operations.
Possibility of nitrogen gas flushing before, during and after filling.
All contact parts made from High Quality Stainless Steel 316L & Non-contact parts made from Stainless Steel 304.
Minimum change over parts from 1ml to 10ml ampoule size.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Open Mouth Ampoule Filler Sealer

Empty washed & sterilized ampoules loaded onto infeed hopper of the machine. From where it has been received to receiving rack through starwheel/cassette. The moving rack which moves horizontally collect one/two/four/eight ampoules from the receiving rack and transfer the ampoule to the machine in left to right in an inclined position. During ampoule movement Pre-gassing, Filling, Post Gassing, Pre-heating & Sealing Station perform filling and sealing operations. At the end duly filled and sealed ampoules get collected automatically onto collection tray of the machine. For detailed working process please explore Automatic Ampoule Filler Video in top right section of this page.

Loading: Empty, washed, and sterilized ampoules are loaded into a hopper and transferred to a traveling rack via a starwheel in groups of one, two, four, or eight, depending on the machine’s head configuration.

Nitrogen Purging: Ampoules are flushed with nitrogen gas to remove air and prevent oxidation.

Filling: Filling needles dispense a preset liquid volume into the ampoules with neck centering for precision.

Post-Nitrogen Flush: A second nitrogen flush occurs to further ensure product stability.

Pre-Warming and Sealing: Ampoules are warmed with a low-pressure flame, then sealed using oxygen/LPG flames and rotating rollers for a uniform seal.

Collection: Filled and sealed ampoules are collected upright on a dead tray for further processing.

Technical Specification of Open Mouth Ampoule Filler Sealer

Model	AFS-1	AFS-2	AFS-4	AFS-8
No. of Head	Single	Two	Four	Eight
Syringes	One	Double	Four	Eight
Ampoule Sizes	1 ml to 30 ml	1 ml to 30 ml	1 ml to 20 ml	1 ml to 20 ml
Filling Speed	Up to 25 ampoules/minute	Up to 50 ampoules/minute	Up to 100 ampoules/minute	Up to 200 ampoules/minute
Filling Precision	± 1%	± 1%	± 1%	± 1%
Filling Pump	Piston Pump	Piston Pump	Piston Pump	Piston Pump
Burner Gas	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)
Nitrogen Arrangement	Before & After Filling	Before & After Filling	Before & After Filling	Before & After Filling
Number of Fill Nozzles	One	Two	Four	Eight
Number of Nitrogen Nozzles	Two	Four	Eight	Sixteen
Number of Sealing Burners	Two	Four	Eight	Sixteen
Power Required	0.5 H.P.	1 H.P.	1 H.P.	2 H.P.
Power Voltage	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System
Contact Parts	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L
Overall Dimension	915mm (L) x 610mm (W) x 965mm (H) approx.	915mm (L) x 760mm (W) x 965mm (H) approx.	1200mm (L) x 1070mm (W) x 965mm (H) approx.	2200mm (L) x 1400mm (W) x 1100mm (H) approx.

* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.

Types of Ampoule Filling Machine

Automatic Ampoule Filling Sealing Machine

Laboratory Ampoule Filling Sealing Machine

Closed Ampoule Filling Machine

Open Mouth Ampoule Filling Machine

Onion Skin Ampoule Filling Machine

Single Head Ampoule Filling Machine

Double Head Ampoule Filling Machine

Four Head Ampoule Filling Machine

Six Head Ampoule Filling Machine

Eight Head Ampoule Filling Machine

Applications of Ampoule Filling Machine

Advantages of Open Mouth Ampoule Filler Sealer

High Precision: Accurate filling volumes (0.5ml to 30ml) with minimal wastage due to features like the “No Ampoule, No Fill” system.

Sterility: Nitrogen flushing and immediate sealing prevent contamination, ensuring product purity.

Flexibility: Handles a wide range of ampoule sizes (1ml to 30ml) with minimal changeover time.

High Output: Capable of processing up to 36,000 ampoules/hour in high-speed models, ideal for large-scale production.

Ease of Maintenance: Full accessibility, quick changeover parts, and robust stainless steel construction simplify cleaning and upkeep.

Compliance: Meets cGMP standards, with optional CE certification and 21 CFR Part 11 compliance for regulatory needs.

Key Features of Open Mouth Ampoule Filler Sealer

Purpose: The machine fills open-mouth glass ampoules (typically Type B or Type C) with liquid or other substances and seals them to ensure sterility and prevent contamination. It is ideal for products like agro-insecticides, veterinary medicines, cosmetic serums, and pharmaceutical injectables.

Operation:
- Filling: Ampoules are filled with precise volumes (0.5ml to 25ml in a single dose) using a volumetric piston-pump system or alternative mechanisms like servo-driven or peristaltic pumps. The machine ensures neck centering during filling to avoid spillage.
- Nitrogen Purging: Nitrogen gas is flushed before and after filling to minimize oxidation and contamination, ensuring product integrity.
- Sealing: Ampoules are sealed using oxygen and LPG (propane) flames. A pre-warming station heats the glass to ensure perfect sealing, followed by a sealing station where rollers rotate the ampoules for uniform closure.

Design:
- Monobloc Structure: Combines filling and sealing in a single unit for efficiency and space-saving.
- Material: Contact parts are made of high-quality stainless steel 316L for cGMP compliance, while non-contact parts use stainless steel 304.
- Dead Tray: Facilitates upright collection of filled and sealed ampoules, improving handling and organization.
- Ampoule Handling: Supports ampoules from 1ml to 30ml, with minimal changeover parts for different sizes, enhancing flexibility.

Performance:
- Speed: Can process 10 to 250 ampoules per minute, depending on the model (single, two, four, six, or eight heads). High-speed models can achieve up to 12,000 ampoules per hour.
- Precision: Features like neck centering and non-return valves ensure accurate filling with no leakage or spillage.

Additional Features:
- Pre-Heating Unit: Ensures proper sealing, especially for thicker glass ampoules.
- No Ampoule, No Fill: Prevents wastage by stopping the filling process if no ampoule is detected.
- Easy Maintenance: Full accessibility and minimal changeover parts simplify cleaning and upkeep.
- Optional Features: Includes PLC systems with graphical user interfaces, inbuilt laminar airflow for sterile filling (Class 100), and waste tip collectors for clean operation.

Available in single, two, four, six, or eight-head models to suit different production scales, from lab-scale (1,500 ampoules/hour) to high-speed production (12,000 ampoules/hour).

Customizable filling mechanisms (piston pump, servo-driven, or peristaltic pump) based on user needs.

FAQ for Open Mouth Ampoule Filler Sealer

What is an Open Mouth Ampoule Filler Sealer?

An Open Mouth Ampoule Filler Sealer is a fully automatic monobloc machine designed for filling and flame sealing of open mouth glass ampoules (Type B & Type C). It is widely used for sterile liquid injectables where the ampoule neck is already open. The machine integrates nitrogen flushing (pre- and post-filling), precise volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. It is ideal for pharmaceutical, biotech, and veterinary injectable production and complies with cGMP, USFDA, and WHO standards.

What are the available models and production capacities of the Open Mouth Ampoule Filler Sealer?

We offer four standard models:

AFS-1 (Single Head): Up to 25 ampoules per minute (~1,500 per hour)
AFS-2 (Two Heads): Up to 50 ampoules per minute
AFS-4 (Four Heads): Up to 100 ampoules per minute (~6,000 per hour)
AFS-8 (Eight Heads): Up to 200 ampoules per minute (~12,000 per hour)

Custom high-speed models are available up to 36,000 ampoules per hour. The machine supports ampoule sizes from 1ml to 30ml with filling volumes from 0.5ml to 25ml and filling accuracy of ±1%.

What are the key advantages of using an Open Mouth Ampoule Filler Sealer?

Open Mouth Ampoule Filler Sealers offer several advantages compared to closed-mouth machines:

Simpler design with no extra ampoule opening station, resulting in lower cost and easier maintenance
Faster and easier format changeover with fewer parts
Lower risk of mechanical issues and reduced spare parts requirement
Gentle slant traveling principle for minimal glass breakage
High production efficiency and excellent sterility due to immediate nitrogen flushing and flame sealing

These features make it a preferred choice for medium to large-scale injectable production.

How does the Open Mouth Ampoule Filler Sealer work?

The machine operates on the slant traveling principle for smooth ampoule movement. The process flow is:

Sterilized open mouth ampoules are loaded into the hopper
Nitrogen pre-flushing to remove oxygen
Precise filling using piston pumps with neck centering
Nitrogen post-flushing
Neck pre-warming
Flame sealing with accurately controlled LPG + Oxygen burners

Safety systems like “No Ampoule – No Filling” and “No Ampoule – No Seal” ensure zero wastage. Sealed ampoules are collected automatically on a tray.

Which industries use the Open Mouth Ampoule Filler Sealer and what are its main benefits?

It is widely used in:

Pharmaceuticals (parenteral injectables and vaccines)
Biotechnology
Veterinary medicines
Cosmetics
Chemical and agro-insecticide industries

Main benefits include:

Lower initial investment and maintenance cost compared to closed-mouth systems
High filling accuracy (±1%) with minimal product wastage
Reduced glass particle generation and breakage
Fast format changeover and easy cleaning
Full cGMP compliance with easy validation
Compact footprint and seamless integration into complete injectable lines

Is Open Mouth Ampoule Filler Sealer cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Open Mouth Ampoule Filler Sealer complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

What is the lead time for Open Mouth Ampoule Filler Sealer?

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Does Adinath International provide Open Mouth Ampoule Filler Sealer internationally?

Yes, Adinath International Open Mouth Ampoule Filler Sealer export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Does After Sales Support provided for Open Mouth Ampoule Filler Sealer?

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of Open Mouth Ampoule Filler Sealer stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.