Working Principle of Automatic Ampoule Inspection Machines

Ensuring that all of the drug ampules produced for injection are complete and meet the required quality specifications is crucial to protecting patients and meeting regulatory requirements. Historically, manual inspection of each individual ampule was performed with visual examination; although there were many negative aspects of this process, such as variability, potential for operator fatigue, which could lead to errors, and general inefficiencies. The increasing demand for the pharmaceutical manufacturing industry to produce products at increasingly higher levels of precision and faster has prompted manufacturers to utilize Automatic Ampoule Inspection Machines (AAM) to perform their quality assurance inspections. This article will be a general overview of what an AAM is, how it functions and why AAMs are so critical to the Pharmaceutical Manufacturing Industry.

What is an Automatic Ampoule Inspection Machine?

A fully automated ampoule inspection system has the ability to inspect ampoules at very high speeds using advanced technology to measure the integrity of the ampoule by identifying defects. These systems are primarily used for assurance that all ampoules meet the strictest quality specifications before entering into the manufacturing process.

Types of Defects Detected

The types of defect identification include:

• Particulate Matter: Any foreign matter (particulates) suspended within the liquid contained within an ampoule.
• Fill Level Deviations: Ampoules which contain either too little (underfilling) or too much (overfilling) of the liquid contained within the ampoule may be inaccurate as to the amount of active ingredients delivered via administration of the medication.
• Cracks & Chips: A crack in the ampoule is a break in the glass that could allow liquid to escape from the ampoule (causing contamination), or create an opening for contamination into the ampoule.
• Failure of Seals/Tips: There was some failure of the tip seal forming correctly, or there was damage to the tip seal during the manufacturing process; this would be a serious threat to the sterility of the ampoule.
• Failure of Seals/Tips: There was some failure of the tip seal forming correctly, or there was damage to the tip seal during the manufacturing process; this would be a serious threat to the sterility of the ampoule.

Typical Configurations

Inspection machines designed for automatic inspection of ampoules have been developed into a variety of configurations based on the requirements of the manufacturing process:

• Rotary Systems: The Ampoule is rotated at high speed to allow an inspection camera to view each surface of the ampoule during inspection.
• Linear Systems: The linear motion is created by moving an ampoule along a straight conveyor line to provide a fixed location where it can be inspected.
• AI-Enabled Systems: Utilize AI-enabled machine learning algorithms to identify defects and produce fewer false reject results than non-AI systems.

Common Industries Using These Machines

These machines are widely used across:

• Pharmaceutical manufacturing
• Biotechnology
• Vaccine production
• Diagnostic reagent production

Working Principle of Automatic Ampoule Inspection Machine

A series of inspection steps is implemented to allow a thorough examination of each ampoule as it moves through the inspection process:

Infeed and Orientation

Trays or bulk feeders introduce ampoules into the machine, orientation devices then ensure that each ampoule will face the camera in the correct position (the proper orientation is required to obtain consistent inspection coverage).

High-Speed Rotation / Turbulence Creation

After being properly oriented, the ampoules are spun at a high speed to create turbulence within the liquid contained in the ampoule. The turbulence created by spinning the ampoules helps to expose particulate contaminants present in the solution (particulates may remain hidden in the solution when static).

Vision System and Illumination

A variety of lighting methods are used in conjunction with high-resolution cameras to clearly show details of the ampoule as well as to make defects more easily visible:

• Back Lighting allows for easier viewing of clear defects and fill level in the ampoules.
• Strobe Lighting is used to freeze motion while rotating to capture a sharper image.
• Dome Diffused Lighting helps to eliminate shadows and to allow surface defects to be viewed more easily.

Since each type of lighting will help identify specific types of defects, they can be combined to provide a complete inspection.

Image Capture & Real-Time Analysis

Image Capture & Real-Time Analysis

• Particle movement within the liquid
• Cracks or chips in the glass body
• Variations in fill level
• Seal and neck defects such as improper closure or contamination

Classification & Pass/Reject Decision

The analytical results will be used to classify each ampoule in one of two categories, either acceptable or unacceptable. The use of artificial intelligence-based decision-making can significantly reduce the number of rejected samples that are not actually defective, therefore enhancing operational performance. Regulatory requirements related to quality control within the pharmaceutical industry have been met to ensure that no ampoule that may be defective is allowed to advance through the manufacturing process.

Rejection and Outfeed

Those ampoules identified as being non-conforming due to a defect are mechanically or pneumatically rejected from the manufacturing line. Those ampoules that were classified as conforming are directed to the packaging areas without disrupting the normal flow of products on the manufacturing floor.

Importance of Automated Inspection in Pharmaceuticals

Automated Ampoule Inspection Machines are necessary to help in the following ways:

• Makes sure that every single item is inspected (100%), a feat that cannot be guaranteed by manual means.
• Reduces human error and bias, thereby increasing the reliability of the inspection.
• Safeguards patient safety through assurance against contamination or defective products.
• Meets or exceeds strict regulations that govern pharmaceutical manufacturing (US FDA, EU GMP, 21 CFR Part 11).
• Provides complete documentation for audit purposes, including traceability for reporting of batches.

Applications Across Industries

Automatic ampoule inspection machines are used by a variety of industries beyond typical pharmaceutical injectable applications:

• Vaccine and Biological Products: Used to ensure ampoules are sterile and effective.
• Veterinary Medications: Used on veterinary medicines packaged in ampoules.
• Cosmetic Ampoules: Inspect beauty serums and treatments packaged in ampoules.
• Nutritional Supplements (Nutraceuticals): Ensure quality of vitamins and supplements packaged as liquids in ampoules.
• Laboratory Reagent Ampoules and Diagnostic Test Ampoules: Ensure accuracy of laboratory tests.

These inspection machines can be applied to inspect both clear, tinted and amber glass ampoules that meet the required levels of protection for each of these products.

Easy Integration with Filling and Sealing Machines

The integration of Automatic Inspection Machines is seamless in production line processes:

• Compatible with all types of equipment upstream (filling and sealing) and downstream (labelling and packaging).
• Integrated with a SCADA system (centralized control and data acquisition) to monitor centrally, MES systems, or Industry 4.0 systems to monitor centrally.
• The Inline inspection process allows you to synchronize with the production speed, thus minimizing the bottleneck that is created and maximizing the production rate.
• Self-contained inspection units provide flexibility to operate with small-scale and/or batch productions.

Improving Operational Efficiency

The automatic ampoule inspection equipment increases operational productivity in the following ways:

• High-capacity (high-throughput) production capabilities, capable of inspecting hundreds or even thousands of ampoules per minute, depending on the model
• Labour reduction; reduced man-hours = reduced labour cost
• Quality decision-making with real-time analysis of defects detected
• Deep learning artificial intelligence (AI) technology significantly reduces the false reject rate, thus preventing waste and unnecessary disposal of acceptable products.
• Maintenance predictive features help reduce/eliminate unplanned downtime; therefore optimizing the overall performance of equipment.

Conclusion

Pharmaceutical ampoule inspection machines are a must-have for pharmaceutical companies that manufacture injectable products for patient safety. Vision systems, combined with smart software, have dramatically improved the consistency and reliability of inspections compared to manually inspecting each item. Pharmaceutical manufacturing companies looking to comply with regulations and improve the safety of their products now have no option other than using these automation systems to accomplish this goal.