Container Integrity Testing
Contamination such as humidity, oxygen or microbiological ingress can impact drug stability throughout the product life cycle. To prevent the risks of stability failure of highly moisture-sensitive drugs (e.g. dry powder for inhalation), or the risk of biological ingress of parenteral drugs, integrity tests with a high sensitivity are required. Most test methods are very challenging in regards to time effort, complexity or the limitation of sensitivity and detection range. Leak testing and Container Integrity Testing can be required for a large variety of drug/container combinations.
Scitek offers two efficient solutions to suit your needs.
Optical Emission Spectroscopy
Our patented O.E.S. (Optical Emission Spectroscopy) method does not require any specific tracer gas. Instead, the gas mixture present in the container headspace of the primary packaging is used to perform high sensitivity tests with high throughput. A multi-gas sensor is used to independently track the different gases (i.e. argon, nitrogen, CO2, humidity,…) escaping from a leaky container exposed to vacuum. Our method is non-destructive, deterministic, easy to use and to set up, and has higher sensitivity than other conventional methods.
Optical emission spectroscopy, an innovative CCIT solution for the pharmaceutical industry
With the AMI 1000, the products can be sampled directly from the production line and loaded in the test chamber without any specific conditioning. At the end of the test sequence, the result is clearly displayed and a PDF report is automatically generated at the batch closure. Full automation of the test cycle including loading/unloading of the samples can be easily implemented for in-line tests.
Dedicated to the pharmaceutical industry
AMI 1000 equipment has been qualified by leading pharmaceutical companies as in-process control (IPC) leak testing for blister packs. Our software is CFR21 part 111) compliant.
Large detection range
Different detection methods can be combined in order to cover the complete detection range. Massive leak and fine leak tests are performed within a single test sequence, any additional gross leak test (e.g. blue dye ingress) can be omitted.
Deterministic test method
As no operator intervention is required, the measurement results are totally objective. High accuracy measurements can be achieved thanks to a calibration-validation sequence of the equipment based on certified calibrated leaks.
High sensitivity, high throughput
High sensitivity tests combined with high throughput enables trend analysis to early indicate production issues. In high sensitivity mode, O.E.S is able to detect 0.2 μm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leakage Limit) in the USP2) <1207> guidelines.
Download Brochure : AMI 1000 - Brochure
Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines). FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over 10 years.
ME 2 System
Packaging solutions for container closure integrity
Mass Extraction has been recognized worldwide as one of the most sensitive, robust and reliable testing technologies. Utilizing our Mass Extraction Technology, this unit is specialized for nondestructive container closure integrity testing (CCIT) for pharmaceutical packaging, medical device packaging, and food & beverage containers. Our Mass Extraction solutions help you comply with US FDA requirements for sterile products and other industry requirements for preventing moisture and oxygen ingress or hazardous material spills.