Pharmaceutical Glass Ampoule Washer

Q: What is the production capacity and which ampoule sizes does the Pharmaceutical Glass Ampoule Washer support?

The machine is available in two models: AVRW 120 – Up to 100 ampoules per minute AVRW 240 – Up to 200 ampoules per minute It handles glass ampoules with diameters from 9mm to 21.5mm (typically 1ml to 10ml or up to 20ml/25ml depending on configuration). Quick-change parts allow easy and fast size changeover for different batch requirements.

Q: What utilities are required and is the Pharmaceutical Glass Ampoule Washer cGMP compliant?

Utilities required: Power: 4 HP (AVRW 120) or 5.5 HP (AVRW 240), 440V, 3 Phase, 50 Hz (customizable) Compressed Air: Approx. 20 CFM Water: 200–500 liters per hour (depending on model and size) Yes, it is fully cGMP compliant with polished SS 316L contact parts, safety interlocks, advanced filtration, and support for IQ/OQ/DQ validation documentation. Optional 21 CFR Part 11 compliant controls are available to meet stringent regulatory standards.

Description

A Pharmaceutical Glass Ampoule Washer is a specialized piece of equipment designed to clean and sterilize glass ampoules used in the pharmaceutical, biotech, and related industries to ensure they are free from contaminants before filling with medications, vaccines, or other sensitive products. These machines are critical for maintaining sterility, compliance with Good Manufacturing Practices (GMP), and ensuring product safety and efficacy. The primary function of a pharmaceutical glass ampoule washer is to remove contaminants such as particulate matter, microorganisms, chemical residues, and endotoxins (pyrogens) from the internal and external surfaces of glass ampoules. This ensures the ampoules meet stringent sterility and cleanliness standards required for packaging injectable drugs, vaccines, biopharmaceuticals, or other sensitive substances. These machines are widely used in pharmaceutical production, biotechnology, vaccine manufacturing, healthcare settings, and research laboratories.

Pharmaceutical glass ampoule washers are indispensable for ensuring the cleanliness and sterility of ampoules in high-stakes industries like pharmaceuticals and biotechnology. Available in various configurations (automatic, semi-automatic, rotary, ultrasonic, etc.), these machines offer tailored solutions for different production scales and requirements. With advanced features like PLC control, GMP-compliant materials, and validation support, they ensure compliance, safety, and efficiency in the production of sterile injectable products.

The cleaning process typically involves multiple stages to ensure thorough decontamination:

Pre-Washing: Initial rinsing to remove loose particles or residues, often using purified or distilled water.

Main Washing: Uses pressurized jets of water, compressed air, or cleaning agents (e.g., water for injection, acid/alkaline solutions) to clean internal and external surfaces. Some machines incorporate ultrasonic cleaning for enhanced removal of stubborn residues like proteins or lipids.

Rinsing: Multiple rinsing cycles with purified water or water for injection (WFI) to remove cleaning agents and residual contaminants.

Drying: Filtered hot air or other drying systems remove residual moisture to prevent contamination or product degradation. Some machines include high-temperature drying or steam sterilization for depyrogenation (endotoxin removal).

Sterilization (Optional): Advanced models integrate steam sterilization (SIP) or high-temperature treatments (e.g., above 250°C) to eliminate endotoxins, crucial for injectable production.

Salient Features of Pharmaceutical Glass Ampoule Washer

Complete cGMP model.
Production output capacity up to 200 ampoules per minute.
All contact parts with the internal surface of Container and the wash media are made from AISI 316L Stainless Steel.
Non-contact parts are made from engineering plastic, AISI SS 304 materials.
All finishes, welding joints are processed, treated & equipment selected in accordance with cGMP standards.
Machine provides 3 water washes & 3 Air washes.
Complete flexibility with user for washing cycle.
18 Jets for 6 internal washing zones.
15 Cassette of Grippers each having 2 Grippers.
Suitable for 1ml to 10ml ampoules.

Washing sequence can be adjusted as per customer’s requirements.
3 Pumps and 3 Tanks of 25 liters each. (Optional)
Each washing zone with independent circuit to avoid contamination.
Automatic Infeed and Exit of containers.
Machine is equipped with PLC system & printing facility with passwords. (Optional)
Container unit counter with display in the control panel
Machine can use as a sole machine or inline.
Digital speed indicator for current output
IQ/OQ/DQ validation documentation can be provided.
Programming and software validation as per 21 CFR Part 11 can be done on demand.

Working Principle of Pharmaceutical Glass Ampoule Washer

Ampoules feed from the Infeed tray are received on an Infeed Feed worm then moves on Infeed starwheel. The Grippers picks up the Ampoule from Infeed Star Wheel and invert it in neck down position over washing needles and move along with the needle bar for Washing. Ampoules traveling in neck down position above washing needles and moves along with the Needle bar ensures maximum time for washing once the needle enter in the Ampoule neck. Machine having six different washing stations each of 6 needles for optimum Washing and the sequence can be adjusted as per requirements. Washer also having external wash for optimum washing of ampoules.

On completion of a cycle, washed Ampoules are again inverted to neck upward position and feed to output star wheel. Washed Ampoules received from output starwheel can be collected on Output Tray or can be pushed to tunnel. A separate pumping station (optional) gives the right quantum of water at the desired pressure. In the absent of separate pumping station, we can provide the re-circulation & siliconization system on request.

INTERNAL CLEANING:

The AVRW is equipped with 6 internal cleaning stations and each station has 6 cleaning needles making up a total of 36 cleaning needles. Each cleaning station is supplied via a pipe connected to the cleaning media-making washing area. This not only reduces the risk of particle generation, but also simplifies maintenance and cleaning efforts while saving time.

EXTERNAL CLEANING

The 3 external cleaning stations mounted in a stationary position above the ampoule can be easily adjusted for a specific height, angle and lateral position. Each cleaning station receives cleaning media-making through a pipe connected to the cleaning media-making washing area.

CLEANING MEDIA PRINCIPAL:

WFI, Purified water and air cleaning station are synchronized with the ampoule by reciprocating motion. Design is such that these media are put to use only when needles motion in forward direction. WFI consumption is further reduced by collecting the WFI in re-circulating water tank to be used later on in the pre-washing station.

Technical Specification of Pharmaceutical Glass Ampoule Washer

Model	AVRW 120	AVRW 240
Production Output	Up to 100 per minute	Up to 200 per minute
Ampoule Diameter	9mm to 21.5mm	9mm to 21.5mm
Ampoule Height	60mm to 140mm	60mm to 140mm
Power Load	4 H.P.	5.5 H.P.
Power Voltage	440 Volts, 3 Phase 50 Hertz, 4 wire system	440 Volts, 3 Phase 50 Hertz, 4 wire system.
Optional Accessories	Programmable Logic Control (System) with HMI Safety Cabinet with doors	Programmable Logic Control (System) with HMI Safety Cabinet with doors
Utility	Air – 20 CFM Water – 200 to 500 liters per hour depend upon ampoule size.	Air – 20 CFM Water – 200 to 500 liters per hour depend upon ampoule size.
Water Tank & Pump	3 nos. each with 25 liters Capacity & Centrifugal pump	3 nos. each with 25 liters Capacity & Centrifugal pump
Overall Dimension:	2050mm (L) X 2000mm (W) X 1210mm (H) approx.	2450mm (L) X 2000mm (W) X 1300mm (H) approx.
Net Weight	700 kgs. approx.	900 kgs. approx.
Gross Weight	1000 kgs. approx.	1300 kgs. 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 Washing Machine

Ampoule Vial Washing Machine

Automatic Ampoule Washer

Automatic Rotary Ampoule Washing Machine

Automatic External Ampoule Washing Machine

High Speed Ampoule Washing Machine

Lab Scale Ampoule Washing Machine

Multijet Ampoule Washing Machine

Linear Ampoule Washing Machine

Applications of Ampoule Washing Machine

Regulatory Compliance of Pharmaceutical Glass Ampoule Washer

GMP (Good Manufacturing Practices): Ensures standardized, traceable cleaning processes.

FDA Guidelines: Compliance with 21 CFR Part 211 for pharmaceutical manufacturing.

USP : Guidance on package integrity for sterile products.

ISO 11607: Requirements for sterile packaging systems.

Annex 1: Guidelines for validating container closure systems.

Washing Cycle of Pharmaceutical Glass Ampoule Washer

1^st wash	Recycled Water (WFI)
2^nd wash	Compressed Air
3^rd wash	DM Water
4^th wash	Compressed Air
5^th wash	Water for Injection (WFI)
6^th wash	Compressed Air

Importance of Pharmaceutical Glass Ampoule Washer

Ampoule washers are critical for:

Preventing Contamination: Removing residues and microorganisms to ensure product safety.

Ensuring Sterility: Critical for injectables, where contamination can pose serious health risks.

Regulatory Compliance: Meeting stringent standards to pass audits and ensure product approval.

Product Quality: Maintaining the efficacy and stability of drugs by preventing chemical interactions or degradation due to residual moisture or contaminants.

Key Features of Pharmaceutical Glass Ampoule Washer

Material Construction: Contact parts are typically made of high-quality stainless steel (316L) or FDA-approved materials like silicone or polycarbonate to ensure chemical inertness and compliance with GMP standards. Non-contact parts are often stainless steel 304.

Automation and Control: Many machines feature PLC (Programmable Logic Controller) systems with Human-Machine Interfaces (HMI) for precise control of washing parameters (e.g., water temperature, pressure, cycle duration). This ensures repeatability and compliance with regulatory standards.

Versatility: Designed to handle various ampoule sizes (1ml to 20ml) and sometimes vials (2ml to 100ml) with minimal changeover parts.

Sterility Assurance: Incorporates features like segregated washing circuits, ultrafiltration for sterile water, and nitrogen flushing to prevent contamination.

Validation and Traceability: Supports cleaning validation (IQ/OQ/PQ) with data logging for parameters like temperature, pressure, and cycle time, ensuring compliance with FDA, USP, and ISO standards.

Compact Design: Some models have a reduced footprint to save space in production areas, with easy access for maintenance and cleaning.

Safety Features: Include mechanisms like “No Ampoule – No Washing” to prevent wastage and ensure accurate cleaning, as well as automatic stop if covers are lifted during operation.

FAQ for Pharmaceutical Glass Ampoule Washer

What is a Pharmaceutical Glass Ampoule Washer and what is it used for?

A Pharmaceutical Glass Ampoule Washer is a high-speed automatic rotary washing machine designed to thoroughly clean glass ampoules both internally and externally. It removes contaminants such as particulate matter, microorganisms, chemical residues, fibers, dust, and endotoxins (pyrogens) to ensure the ampoules are sterile and ready for filling with injectable drugs, vaccines, biopharmaceuticals, or other sensitive products. It is essential equipment in pharmaceutical, biotech, veterinary, and cosmetic industries for maintaining cGMP compliance and product safety.

What are the key features of the Pharmaceutical Glass Ampoule Washer?

This machine features a robust cGMP-compliant design with AISI SS 316L contact parts, a neck-gripping system that inverts ampoules for minimal contact and reduced contamination risk, 6 internal washing stations with multiple jets/needles, 3 water washes + 3 air washes with independent circuits to prevent cross-contamination, adjustable washing sequences, water recirculation to minimize WFI usage, digital speed indicator, container counter, acrylic safety covers with interlocks, and quick-change parts. It supports standalone or inline operation with filling lines. Optional PLC with HMI and 21 CFR Part 11 compliance are available.

What is the production capacity and which ampoule sizes does the Pharmaceutical Glass Ampoule Washer support?

The machine is available in two models:

AVRW 120 – Up to 100 ampoules per minute
AVRW 240 – Up to 200 ampoules per minute

It handles glass ampoules with diameters from 9mm to 21.5mm (typically 1ml to 10ml or up to 20ml/25ml depending on configuration). Quick-change parts allow easy and fast size changeover for different batch requirements.

How does the washing process work in the Pharmaceutical Glass Ampoule Washer?

Glass ampoules are loaded onto the infeed tray and transferred via starwheel or feed worm. Grippers hold them by the neck, invert them neck-down, and move them over reciprocating washing needles across 6 internal stations. The machine performs a customizable 3 water + 3 air wash cycle (e.g., Recycled WFI → Air → DM Water → Air → Fresh WFI → Air) with simultaneous external spraying. Independent circuits ensure no cross-contamination. After washing, ampoules are re-inverted upright and automatically discharged, ready for sterilization or filling.

What utilities are required and is the Pharmaceutical Glass Ampoule Washer cGMP compliant?

Utilities required:

Power: 4 HP (AVRW 120) or 5.5 HP (AVRW 240), 440V, 3 Phase, 50 Hz (customizable)
Compressed Air: Approx. 20 CFM
Water: 200–500 liters per hour (depending on model and size)

Yes, it is fully cGMP compliant with polished SS 316L contact parts, safety interlocks, advanced filtration, and support for IQ/OQ/DQ validation documentation. Optional 21 CFR Part 11 compliant controls are available to meet stringent regulatory standards.

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