Container Closure Integrity Testing: Vials, Ampoules, and Bags
As far as the finishing of pharmaceutical sterile products is concerned, the Annex 1 of the GMP state that integrity testing of container closure must be performed using validated methods. Visual inspection is not regarded as an acceptable integrity test method anymore, at least for fusion sealed containers.
GASPOROX offers very simple but effective equipment providing a validated method to check the integrity of vials, ampoules, and bags. The GASPOROX technology represents a new approach to the quality inspection of product containers.
It is based on TDLAS technology (Tuneable Diode Laser Absorption Spectroscopy). The gas is sensed by sending laser light through the sample, probing the gas content without any change of the sample.
The range of GASPOROX instruments for the pharmaceutical sector are basically two: the GPX 1500 Vial (also applicable to ampoules thanks a very easy change format part) and the GPX 1500 Film Pharma, for plastic bags. They can be used for measuring levels of O2, CO2 and even moisture (H2O).
The key benefits provided by GASPOROX instruments are:
Plug-and-play. No adjustments of any mechanics are required
> Plug-and-play. No adjustments of any mechanics are required
> Self-adjusting makes it easy and fail safe to operate
> Fails safe format change in only 10 seconds
> Deterministic testing
> USP 1207 recommended method
Find out more about GASPOROX in these videos
GASPOROX GPX 1500 Vial for quality control of vials and ampoules
Equipment for package integrity control in the pharmaceutical industry
