THE RIGHT TECHNOLOGY FOR EACH PRODUCT.
Inspection technologies at a glance
Do you want to guarantee that only perfect parenterals leave your company: particle-free, sterile and intact? Check for particles in the product. Check for cosmetic defects in the container. Or test the tightness of the primary packaging. Whatever you need, we can provide the right inspection technology for your requirement, for example:
Inspection for particles and cosmetic defects
High-performance cameras detect particles in the product and visible cosmetic defects in the container. For optimal results, high-definition cameras together with different lighting systems are used. And to obtain clearly comparable evaluations each camera inspects each individual product. A high detection rate and a simultaneous lower false reject rate are achieved, thanks to up to 24 photographs per inspection.
Typical camera inspections are:
- Particles such as glass, fibres, metal and coating fragments in motion, adhering to the bottom or the sidewall; in clear liquids, suspensions, on lyo cakes.
- Cosmetic defects such as dirt, cracks, chips, inclusions in the glass, splashes, burn marks, ampule tip geometry, presence/correct position of plungers, stoppers and flip-off caps, crimping defects, presence of coding rings and OPC point.
Inspection of highly viscous products - a challenge!
If you produce highly viscous products, you know the challenge they pose when it comes to inspection. Seidenader has developed a method to distinguish between inside and ouside contamination of pharmaceutical containers filled with highly viscous products.
High-voltage inspection (HV)
Leak inspection of liquid-filled containers and check for pierced needle shields on syringes
Micro-cracks or pinholes in the sidewall, bottom or closure zone of liquid-filled containers, invisible to cameras, can be reliably detected using high voltage (HV). For this inspection, the inner surface of the container is wetted with the product and the container is conveyed past the electrodes at a small distance. A leak in the object leads to a reduction of the resistance and hence to an increase in the e electrical flow. A container with a measured current higher than a defined maximum will be rejected.
Typical high-voltage inspections are:
- Tightness (HVLD = High Voltage Leak Detection), for ampules, cartridges, vials and syringes, filled with liquid, exhibiting a minimum conductivity of 1 μS/cm.
- Pierced needle shield (HVNSI = High Voltage Needle Shield Inspection) for syringes.
Laser-based headspace analysis (HSA)
Leak inspection of lyo products
Headspace analysis using of TDLAS (Tunable Diode Laser Absorption Spectroscopy) is a spectroscopic method which enables 100% non-destructive inline inspection of pharmaceutical products using various criteria. A laser beam, which is tuned to specific wavelength coverage, passes the headspace of a container. A photo sensor receives the transmitted laser light; evaluation of the sensor signal supplies information about the composition of the gas inside the container.
When containers are sealed under low pressure in a controlled atmosphere, changes of certain parameters of the headspace gas can be detected if ambient air penetrates. Such changes indicate a leak.
A typical HSA application is leak inspection of containers filled with lyophilized product and sealed under low pressure.
HSA O2 - oxygen-based headspace analysis
The HSA O2 system detects leaks produced by the finest cracks, in applications in which regular high voltage leak testing is not possible due to insufficient electrical conductivity, as it is for freeze-dried products.
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