The critical nature of Visual Inspection Test Sets

Coming from a strong background in pharmaceutical manufacturing, eyetec wanted to respond to the need for qualitative and precise container and product defects for Visual Inspection (VI), including Particle Test Samples for pharmaceutical manufacturers.

Preventing casualties

To avoid fatal consequences of micro-particles entering a patient’s bloodstream, aseptic products require strict testing procedures before they can be released on the market and administered to patients.

In addition to the contents, the primary components, like the containers must also remain intact and sterile to avoid contamination or bacterial growth.

Because of the potential disastrous effects, the 100 % inspection for particles is a legal requirement for Goods Manufacturing Practice (GMP) products.

A critical process

In the past, quality inspection was performed manually. However, nowadays, this process is often automated. Visual Inspection Test Sets play a crucial role in evaluating the detection and rejection capabilities of Visual Inspection processes, whether they're manual, semi-automatic or fully automated, against a set performance level. In essence, these sets serve to assess and validate the effectiveness of the methods and equipment utilized during the Visual Inspection of aseptic products. These tests are either done before a new machine is taken into production, after changes, repairs or recalibration, or on an annual basis, in accordance with company policies and regulatory standards.

Initially focusing on Visual Inspection (VI), eyetec expanded its offerings over time by introducing proprietary samples to the market alongside Visual Inspection and container closure integrity testing (CCIT) consultancy services. This strategic evolution allows us to provide comprehensive guidance and support to our customers throughout the entirety of their quality assurance processes. eyetec is among the pioneering providers in this field. To avoid contamination while producing these Visual Inspection Test Sets, the filling and sealing process is done in our laminar flow booth, which is an isolated clean environment. And before releasing the samples to the client, they are double checked on a semi-automatic Visual Inspection device.

Different types of Particle Test Samples 

The inserted particles can vary in nature and size, ranging from glass or rubber splinters of around 75 microns to fibres of up to 3000 microns. We also produce other product defects, like over and under filled samples, turbidity or colour variations and container defects such as cracks, scratches or cap and crimp defects. The defects are typically categorised into three levels: critical, major, and minor defects. 

These product and container defects can be created for various types of products in different types of containers: vials, syringes, cartridges, ….

3 types of defects

Defects are typically categorized into three levels: critical, major, and minor defects.

• Critical defects: these are defects that do not meet mandatory regulations and/or pose risks to the safety of consumers or end users.
• Major defects: these defects result in product failure and significantly reduce the product's usability or marketability.
• Minor defects: these deviations from quality standards are less likely to impact the usability or marketability of the product.

Today, eyetec supplies Visual Inspection Test Sets to leading pharmaceutical companies worldwide

Drawing from extensive experience within prominent pharmaceutical firms, our experts possess a unique blend of expertise in both compliance and technology. Collaborating closely with pharmaceutical companies through continuous consultancy projects, eyetec gains deep insights into the challenges faced by manufacturers in the industry. This dual approach enables us to provide tailored advice on necessary test sets while simultaneously delivering innovative solutions that meet evolving industry needs.