Crushable Ampoule Filler Sealer Machine

Q: What is a Crushable Ampoule Filler Sealer Machine?

A Crushable Ampoule Filler Sealer Machine is a specialized automatic monoblock system designed for precise filling and hermetic flame sealing of delicate onion skin (thin-walled crushable) glass ampoules. These fragile ampoules are commonly used for Biological Indicators (BI) in sterilization validation. The machine handles thin-walled glass tubes gently using the slant traveling principle, performs nitrogen gassing, volumetric filling, pre-heating, and low-pressure flame sealing — all in one compact platform. It is ideal for pharmaceutical and biotech companies producing sterilization indicators.

Q: How does the Crushable Ampoule Filler Sealer Machine ensure sterility and quality?

Key features for sterility include: Nitrogen flushing before, during, and after filling to remove oxygen and prevent oxidation. Precise LPG + Oxygen flame sealing with rotating rollers for perfect dome-shaped hermetic closure on thin glass. “ No Ampoule – No Filling ” and “ No Ampoule – No Seal ” interlocks to avoid wastage. Stainless Steel 316L contact parts and open cGMP design compatible with laminar airflow for Class 100 aseptic processing. This guarantees consistent spore population and reliable D-value results for sterilization validation.

Q: What are the main benefits of the Crushable Ampoule Filler Sealer Machine?

Minimum breakage — Gentle handling protects fragile onion skin ampoules and reduces costly product loss. Perfect sealing on thin glass — Pre-warming and controlled flame ensure strong, leak-proof seals without deformation. High precision — ±1% filling accuracy for uniform spore suspension volume. Superior sterility — Nitrogen inerting and immediate hermetic sealing enhance product stability and shelf life. Flexibility & efficiency — Suitable for small to medium batch production of Biological Indicators with quick changeover and low maintenance.

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

Yes — Adinath International Crushable Ampoule Filler Sealer Machine 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 Crushable Ampoule Filler Sealer Machine internationally?

Yes, Adinath International Crushable Ampoule Filler Sealer Machine 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

Crushable Ampoule Filler Sealer Machine is specialized equipment designed for filling and sealing crushable glass ampoules, commonly used in pharmaceutical, biotech, cosmetic, and chemical industries for single-dose liquid drugs, vaccines, or other substances. These machines ensure precise filling, sterile conditions, and secure sealing to maintain product integrity until the ampoule is broken for use. Below is a detailed description based on available information:

Machines adhere to stringent regulatory requirements (e.g., cGMP, USFDA, WHO) to ensure product safety, sterility, and compliance.

ISO 9001:2015 certification is common among reputable manufacturers like Adinath International.

Regular cleaning with a soft cloth and periodic deep cleaning to prevent contamination.

Check gas and electric components for wear and replace with genuine parts.

Unplug and turn off gas supply before maintenance to ensure operator safety.

Automation: Fully automatic models reduce manual intervention, with PLC-based control panels for precise fill volume adjustments.

Safety and Cleanability: Equipped with safety valves, pressure reducers, and stainless steel hoods to manage fumes. Large bottom openings facilitate cleaning and maintenance.

Optional Features: Inert gas injectors, laminar airflow cabinets, or isolators for enhanced sterility, and compatibility with biological indicators.

Salient Features of Crushable Ampoule Filler Sealer Machine

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

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.
Ampoule neck centering during gas flushing and filling operations.
Possibility of nitrogen gas flushing before, during and after filling.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Crushable Ampoule Filler Sealer Machine

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.

Technical Specification of Crushable Ampoule Filler Sealer Machine

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 Crushable Ampoule Filler Sealer Machine

High preciGentle Handling with Minimum Breakagesion and sterile operation ensure product safety.

Perfect Hermetic Sealing on Thin Glass

High Precision Dosing for Reliable Results

Flexibility for Small-Diameter & Small-Batch Production

cGMP Compliance and Easy Validation

Cost Efficiency and Reduced Wastage

Enhanced Product Stability & Shelf Life

Key Features of Crushable Ampoule Filler Sealer Machine

Purpose and Application:
- Designed for filling and sealing crushable ampoules, which are glass containers that can be easily broken to access contents, often used for single-dose medications, vaccines, agro-insecticides, or cosmetics.
- Suitable for both open-mouth and closed-mouth glass ampoules, with capacities typically ranging from 1ml to 25ml.

Operation Process:
- Filling: Empty, sterilized ampoules are fed into the machine via a hopper or conveyor, often from a sterilizing tunnel. The machine uses a slant travel mechanism to handle variations in ampoule neck dimensions and thicknesses. Filling is performed with high precision using volumetric piston pumps or needles, delivering volumes as low as 0.5ml to 25ml in a single dose.
- Nitrogen Purging: Many models include pre- and post-filling nitrogen flushing to minimize contamination and preserve product stability.
- Sealing: After filling, ampoules are sealed using combustible gases (typically oxygen and LPG/propane). The sealing process involves pre-warming the ampoule neck with a low-pressure flame, followed by sealing with specially designed rollers to ensure a uniform, contamination-free closure.
- Collection: Sealed ampoules are collected upright in a tray for further processing, with waste tips (from sealing) separated automatically.

Design and Build:
- Material: Contact parts are made of high-quality stainless steel 316L, with non-contact parts in stainless steel 304, adhering to cGMP standards for pharmaceutical use.
- Monobloc Design: Combines filling and sealing in a single unit, reducing footprint and contamination risks.
- Flexibility: Machines are adaptable to various ampoule sizes (1ml to 30ml) and types, with some models offering customizable heads (single, double, four, six, or eight) to suit production needs.

Performance:
- Output: Varies by model, ranging from 20 to 300 ampoules per minute. For example:
  - Single-head machines: ~1,500 ampoules/hour (lab-scale).
  - Four-head machines: ~6,000 ampoules/hour (medium-scale).
  - Eight-head machines: ~12,000 ampoules/hour (large-scale).
- Accuracy: Fill accuracy of ±0.5% ensures precise dosing, critical for pharmaceuticals.
- Sealing Capacity: Some models can handle 700–1,200 ampoules/hour for 1–10ml sizes.

FAQ for Crushable Ampoule Filler Sealer Machine

What is a Crushable Ampoule Filler Sealer Machine?

A Crushable Ampoule Filler Sealer Machine is a specialized automatic monoblock system designed for precise filling and hermetic flame sealing of delicate onion skin (thin-walled crushable) glass ampoules. These fragile ampoules are commonly used for Biological Indicators (BI) in sterilization validation. The machine handles thin-walled glass tubes gently using the slant traveling principle, performs nitrogen gassing, volumetric filling, pre-heating, and low-pressure flame sealing — all in one compact platform. It is ideal for pharmaceutical and biotech companies producing sterilization indicators.

Which ampoule sizes can the Crushable Ampoule Filler Sealer Machine handle?

The machine is engineered to process crushable onion skin ampoules starting from small diameters (approx. 7 mm) up to standard sizes from 1 ml to 30 ml. It supports both mini spore ampoules and slightly larger crushable formats. Filling range is typically 0.5 ml to 25 ml with ±1% accuracy. Quick format changeover with minimum change parts makes it flexible for different Biological Indicator configurations.

Why is a dedicated Crushable Ampoule Filler Sealer required for onion skin ampoules?

Standard ampoule fillers often cause breakage or improper sealing on thin-walled crushable ampoules due to vibration and high flame intensity. This specialized machine uses gentle slant travel, low-vibration handling, neck centering, and a pre-warming station with controlled low-pressure flame. These features prevent cracking, ensure uniform hermetic seals, and maintain the integrity of sensitive spore suspensions used in Biological Indicators.

How does the Crushable Ampoule Filler Sealer Machine ensure sterility and quality?

Key features for sterility include:

Nitrogen flushing before, during, and after filling to remove oxygen and prevent oxidation.
Precise LPG + Oxygen flame sealing with rotating rollers for perfect dome-shaped hermetic closure on thin glass.
“No Ampoule – No Filling” and “No Ampoule – No Seal” interlocks to avoid wastage.
Stainless Steel 316L contact parts and open cGMP design compatible with laminar airflow for Class 100 aseptic processing.

This guarantees consistent spore population and reliable D-value results for sterilization validation.

What are the main benefits of the Crushable Ampoule Filler Sealer Machine?

Minimum breakage — Gentle handling protects fragile onion skin ampoules and reduces costly product loss.
Perfect sealing on thin glass — Pre-warming and controlled flame ensure strong, leak-proof seals without deformation.
High precision — ±1% filling accuracy for uniform spore suspension volume.
Superior sterility — Nitrogen inerting and immediate hermetic sealing enhance product stability and shelf life.
Flexibility & efficiency — Suitable for small to medium batch production of Biological Indicators with quick changeover and low maintenance.

Is Crushable Ampoule Filler Sealer Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Crushable Ampoule Filler Sealer Machine 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 Crushable Ampoule Filler Sealer Machine?

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 Crushable Ampoule Filler Sealer Machine internationally?

Yes, Adinath International Crushable Ampoule Filler Sealer Machine 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 Crushable Ampoule Filler Sealer Machine?

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 Crushable Ampoule Filler Sealer Machine stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.