Automatic Ampoule Washing Machine

Q: What is an Automatic Ampoule Washing Machine and why is it used in pharmaceuticals?

An Automatic Ampoule Washing Machine is a cGMP-compliant rotary washer designed to thoroughly clean the internal and external surfaces of glass ampoules using high-pressure water and air jets. It removes dust, particles, and contaminants before filling, ensuring sterility and compliance with pharmaceutical standards. The machine uses a gripper system that holds ampoules by the neck with minimal contact, inverts them for effective washing, and is ideal for injectable, veterinary, biotech, and cosmetic production lines.

Q: What is the production capacity and ampoule size range of the machine?

The machine is available in two models: AVRW 120 : Up to 100 ampoules per minute AVRW 240 : Up to 200 ampoules per minute It is suitable for ampoules ranging from 1ml to 10ml , with diameters of 9mm to 21.5mm and heights of 60mm to 140mm. The washing sequence and speed are adjustable as per customer requirements.

Q: Is Automatic Ampoule Washing Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Automatic Ampoule Washing 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 Automatic Ampoule Washing Machine internationally?

Yes, Adinath International Automatic Ampoule Washing 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

An Automatic Ampoule Washing Machine is a highly specialized pharmaceutical device engineered to thoroughly clean and sanitize glass ampoules used in the production of injectable medicines, vaccines, and sterile liquids. These machines remove dust, particles, microbes, and other contaminants from ampoules before they are filled, ensuring the highest levels of product safety and quality. In today’s stringent regulatory environment, investing in a reliable automatic ampoule washer has become indispensable for pharmaceutical manufacturers, veterinary drug producers, and biotech companies worldwide.

Glass ampoules are the preferred primary packaging for many critical medications because they provide an excellent barrier against contamination. However, during manufacturing, storage, and transportation, ampoules can accumulate microscopic particles, residues, and biological contaminants. Manual cleaning is not only time-consuming and inconsistent but also poses significant risks of re-contamination and human error.

An automatic ampoule washing machine addresses these challenges by delivering high-speed, repeatable, and validated cleaning processes that meet Good Manufacturing Practices (cGMP) and international pharmacopeial standards such as USP, EP, and WHO guidelines. These machines play a vital role in maintaining sterility assurance levels (SAL) required for parenteral products.

Salient Features of Ampoule Washing Machine

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 Ampoule Washing Machine

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 Ampoule Washing Machine

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

Injectable Glass Ampoule Washing Machine

Lab Scale Ampoule Washing Machine

Multijet Ampoule Washing Machine

Rotary Ampoule Washer

Applications of Ampoule Washing Machine

Advantages of Ampoule Washing Machine

Ensures sterility and compliance with cGMP and FDA standards.

High efficiency with minimal operator intervention.

Customizable washing sequences and compatibility with various ampoule sizes.

Reduces contamination risks through minimal contact and advanced filtration systems.

Washing Cycle of Ampoule Washing Machine

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

Design and Operation of Ampoule Washing Machine

Structure: The machine features a compact, enclosed design, typically constructed with AISI 316L stainless steel for contact parts and AISI 304 or FDA-approved engineering plastics for non-contact parts, ensuring durability and hygiene.

Gripper System: A specially designed gripper system holds ampoules by their necks, inverts them for washing, and releases them in a vertical position post-washing, ensuring positive and thorough cleaning with minimal contact.

Rotary Motion: Ampoules are fed via an infeed hopper or tray, aligned by a feedworm, and transferred to an infeed starwheel. The rotary system moves ampoules continuously or via indexing motion through multiple washing stations.

Washing Process:
- Ampoules are inverted (neck down) over washing needles, which enter the ampoule neck for internal cleaning.
- Spray tubes or nozzles, synchronized with ampoule movement, deliver cleaning media (e.g., Water for Injection (WFI), purified water, or compressed air) to internal and external surfaces.
- The machine typically features 6 washing stations, each with 6–8 needles (totaling 36–48 needles), providing 3–6 internal water washes (e.g., recycled water, purified water, WFI) and 3 air washes, plus 1–2 external water and air washes.
- Washing sequences are customizable to meet specific requirements, with independent circuits for each washing zone to avoid cross-contamination.

Output and Re-inversion: After washing, ampoules are re-inverted to a neck-up position, discharged via an output starwheel, and collected on trays or fed directly to a sterilizing tunnel. Optional pumping stations ensure precise water pressure, while recirculation systems reduce WFI consumption.

Key Features of Ampoule Washing Machine

Material: Contact parts are made of AISI 316L stainless steel, while non-contact parts use AISI 304 or FDA-approved materials, ensuring durability and cGMP compliance.

High Throughput: Capable of washing 50–400 ampoules per minute, depending on the model.

Automation and Control: Equipped with PLC systems and user-friendly HMIs for precise control, monitoring, and password-protected settings. Features include digital speed indicators and container counters.

Flexibility: Accommodates ampoule sizes from 1 ml to 20 ml (some up to 100 ml) with change parts for different sizes.

Low Water Consumption: Uses 200–500 liters/hour, depending on ampoule size, with optional recirculation systems.

Safety and Maintenance: Includes protective enclosures, emergency stop functions, and easy-to-dismantle components for cleaning and maintenance.

FAQ for Automatic Ampoule Washing Machine

What is an Automatic Ampoule Washing Machine and why is it used in pharmaceuticals?

An Automatic Ampoule Washing Machine is a cGMP-compliant rotary washer designed to thoroughly clean the internal and external surfaces of glass ampoules using high-pressure water and air jets. It removes dust, particles, and contaminants before filling, ensuring sterility and compliance with pharmaceutical standards. The machine uses a gripper system that holds ampoules by the neck with minimal contact, inverts them for effective washing, and is ideal for injectable, veterinary, biotech, and cosmetic production lines.

What is the production capacity and ampoule size range of the machine?

The machine is available in two models:

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

It is suitable for ampoules ranging from 1ml to 10ml, with diameters of 9mm to 21.5mm and heights of 60mm to 140mm. The washing sequence and speed are adjustable as per customer requirements.

How does the Automatic Ampoule Washing Machine work?

Ampoules are loaded from an infeed tray onto a feed worm and transferred to an infeed starwheel. Grippers pick them up by the neck, invert them (neck-down), and move them over washing needles across six internal washing zones (with 18 jets total). The process includes 3 water washes + 3 air washes with independent circuits to prevent cross-contamination. After washing, ampoules are re-inverted to an upright position and discharged via an output starwheel for further processing (e.g., filling or sterilization). External washing is also provided for optimum cleanliness.

What materials are used and what compliance standards does it follow?

All contact parts (with ampoules and wash media) are made of AISI 316L Stainless Steel, while non-contact parts use AISI SS 304 and engineering plastics. The machine is a complete cGMP model with smooth finishes and welding as per pharmaceutical standards. Optional features include PLC with HMI, password protection, printing facility, and 21 CFR Part 11 compliant software validation. IQ/OQ/DQ documentation is also available.

What are the optional features and utilities required for the machine?

Key optional accessories include:

Separate pumping station with 3 pumps and 3 × 25-liter tanks
Recirculation and siliconization system
PLC system with HMI and printing facility
Safety cabinet with doors

Utilities required:

Power: 4–5.5 H.P. (440V, 3 Phase, 50 Hz)
Compressed Air: 20 CFM
Water: 200–500 liters/hour (depending on ampoule size)

Is Automatic Ampoule Washing Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Automatic Ampoule Washing 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 Automatic Ampoule Washing 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 Automatic Ampoule Washing Machine internationally?

Yes, Adinath International Automatic Ampoule Washing 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 Automatic Ampoule Washing 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 “Machine name” stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.