METTLER TOLEDO
 

X-ray Inspection of Blister Packs

A typical production line
The pharmaceutical industry operates under the strictest quality regulation and product tracking guidelines. New drug packaging trends and product tracking requirements are pushing the boundaries of automated inspection systems.

Blister packs are a commonly used packaging for pharmaceutical products such as tablets often to protect the drug and to ensure the correct and controlled dosage is taken. To comply with FDA regulations and to protect your brand, product inspection equipment must be in place at critical control points in the manufacturing process including the final package areas.

X-ray image of blister pack with missing tablet
Mettler-Toledo Safeline can offer x-ray inspection systems for all variations of blister packs. Leading global pharmaceutical companies currently use SAFELINE x-ray inspection systems to ensure superior product quality and safety.

One such pharmaceutical manufacturer is using a SAFELINE x-ray inspection system to detect missing, broken or partial tablets in 1, 2 and 4 layer blister packs. The company required a versatile machine which is able to inspect their full range of products and would offer a robust solution with an easy to use user interface. Currently tablet counts of 10-24 tablets are packed into three different carton sizes on multiple layers. 

Traditional in-line weighing systems can often not reliably detect a single missing tablet in a blister pack due to the natural variation in the weight of the packaging being greater than a single tablet. To overcome this challenge SAFELINE X-ray designed and manufactured a customized x-ray inspection system which could be incorporated into the existing blister pack production line following GMP (Good Manufacturing Practice). The machine construction is from 316 polished finished stainless steel and all materials are to the highest standard complying with FDA regulations.

The x-ray inspection system offers excellent contamination detection of metal fragments and other non-metallic contaminates. Simultaneously it can detect for missing, broken or partial tablets. The system is also able to identify the following defects in blister packs with up to 4 layers: 

 

No. of layers

Partial tablet

Missing tablet

Missing blister

1

25% to 50% missing

Yes

Yes

2

50% missing

Yes

Yes

4

No

Yes

Yes

A typical blister pack
Another benefit Safeline X-ray offered the manufacturer was the ability to detect overfills or underfills in a single pocket, hence providing the manufacturer a peace of mind and a robust quality check that directly influences the delivery of drug dosages. X-ray inspection is one of the only mechanisms that can determine that the right number of tablets is in each blister pack. The consequence of an unfilled blister compartment may be a health risk to the patient and is certainly a liability issue for the drug supplier.

Inspection rates of 500 blisters per minute are readily achieved and when used to inspect blister packs in their final packaging, the system is also sufficiently sensitive to check for the presence of the important product instruction leaflet.

The Mettler-Toledo x-ray inspection equipment is designed to be a powerful quality control tool using a specifically developed easy-to-operate user interface that uses a detection method that suits 1, 2 and 4 layer packs with minimal parameters or indeed knowledge of x-ray systems settings. This system will insure both the safety and integrity of blister packs by:

  • Detection of metal, glass, stone, high density plastic and other dense contaminants
  • Detection of partial, missing and incorrectly packed tablets in all types of packaging
  • Detection of missing blister packs and leaflets in the final packaging
  • Storing images of rejected products for further analysis and ultimate product traceability
  • These images are easily downloaded via USB or network
X-ray Image of 4 layer blister pack showing 2 tablets missing
The x-ray inspection equipment is reliable and easy to use with an operator intuitive touch screen interface, automatic set-up and password-protected security tiers.

After each inspected item the system is automatically and continuously calibrated to ensure maximum stability and sensitivity of detection for each individual blister pack. Ensuring long term and consistent performance as required in this very demanding market.

SAFELINE overcame the challenge of devising an accurate reject system for light objects, operating at fast line speeds. The air nozzle reject mechanism is able to reject a single blister pack at high speed and accuracy.

With the x-ray inspection system fitted at the end of the production line for the final quality assurance check, pharmaceutical manufacturers can ensure their products consistently meet the highest product safety and quality standards. This protects the manufacturers brand and reputation and of course the customer.

As Mettler-Toledo Safeline manufactures and designs all x-ray inspection systems in-house our experienced global team of dedicated x-ray experts is able to customize each machine to suit any application and process.

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