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 GMP products.
A critical process
In the past, quality inspection was performed manually. However, nowadays, this process is often automated. Particle Test Samples are used to test the detection and rejection rate of the visual inspection process - being manual, semi-automatic or automatic - against a set performance level. In short, Particle Test Samples (PTS) are used to test and qualify the effectiveness of the methods and equipment used during the visual inspection process of aseptic products. These tests are either done before a new machine is taken into production, after changes, repairs or recalibration, or annually, depending on a company’s policy and regulations.
We started with visual inspection (VI) but gradually introduced our own samples to the market in addition to VI and CCIT consultancy, so that we could guide and serve customers through the entire process. Because of the extremely delicate procedure, eyetec is one of the only companies worldwide to deliver Particle Test Samples and container defects. To avoid contamination while producing these Particle Test Samples, 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, ….
Today, eyetec provides all the world’s leading pharmaceutical companies with Particle Test Samples.
Having worked for a big pharmaceutical company, our experts can leverage a combined experience in compliance and technology. Through ongoing consultancy projects eyetec works closely in and with pharmaceutical companies. This allows us to thoroughly understand the challenges pharmaceutical manufacturers are facing. Because of this dual approach we can advise companies on required test sets and deliver cutting-edge products at the same time.
Contact us to discuss your Particle Test Samples requirements or order your samples here: