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Specialty Areas of Expertise:
CCIT is a critical step subject to FDA regulation in the development of any pharmaceutical product. Container closure defects hinder the on-time release of products to clinical trials, dosing schedules, & consumer market. Valuable time you can’t afford to lose.
Pharmaceutical Particle Analysis Services
Particle size distribution significantly impacts drug product efficacy, which makes ingredient specific particle sizing a requirement for today's regulatory environment.
Medical Device Particle Analysis Services
Particle sizing, counting, and identification analysis provides a detailed accounting of foreign particulate matter present on or within a medical device.
Material Particle Analysis Services
Foreign particulate analysis can identify contaminants hiding in your product materials that impact performance, quality, and safety.
We’re here to help. Our experienced team of professionals can help your team decide on the best sampling plans and routine, stability testing.
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Analytical's Expertise
Consult With An Expert About Our CCIT Services
CCI using the CO2 overpressure vessel and CO2 analyzer.
CCI for lyophilized products packaged under vacuum.
CCI for products stored on dry ice.
CCI for products stored in the vapor phase above liquid nitrogen.
CCI for products purged with an inert gas at one atmosphere of total pressure.
Container Closure Integrity Testing (CCIT) Services are Critical.
Pharmaceutical Particle Analysis Services
Particle size distribution significantly impacts drug product efficacy, which makes ingredient specific particle sizing a requirement for today's regulatory environment.
Medical Device Particle Analysis Services
Particle sizing, counting, and identification analysis provides a detailed accounting of foreign particulate matter present on or within a medical device.
Material Particle Analysis Services
Foreign particulate analysis can identify contaminants hiding in your product materials that impact performance, quality, and safety.
Gateway Analytical's CCIT Experts understand and focus 100% of their time on quality control issues related to container closure systems. We offer the latest testing methods, meet all FDA requirements, and are able to execute any study and deliver results on time.
