Pharmaceutical

Pharmaceutical

Pharmaceutical

The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.

Container closure integrity is over and above a quality feature. Container closure integrity determines the safeness of the drug product at the time of use. The selection of the right container closure integrity testing (CCIT) method holds up to the quality standards endorsed by the pharmaceutical manufacturers. Any negligence of CCI is taken seriously by the regulatory bodies. The guidance documents stand by the deterministic, reliable test methods for measuring the industry-wide quality standards.

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Pharmaceutical Package Testing Systems & Services

PTI insures the container closure integrity of pharmaceutical packaging formats that include parenteral products (vials, ampoules, syringes, autoinjectors) to blister packaging, induction sealed bottles and flexible packaging (pouches, sachets and suture packaging). The United States pharmacopeia released guidance in 2016 (USP 1207) stating that deterministic methods are preferred over probabilistic test methods. Test methods offered by PTI are all deterministic and quantitative test methods that ensure the integrity of the supreme level. The PTI inspection systems for pharmaceutical packaging test methods are of the industry gold standard for sensitivity, reliability and performance. They are also non-destructive test methods that create zero waste.

PTI’s technologies are the most sensitive and most reliable solutions for pharmaceutical packaging applications where the results have a significant impact on stability studies, clinical trials, production performance and patient safety..

We offer a wide range of products and comprehensive services that meet the container closure requirements of the pharmaceutical industry and regulatory agencies.

Get in touch with us to learn more.

Pharmaceutical
914.337.2005
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ptiusa

Nos technologies sont conformes aux normes ASTM et autres normes r�glementaires.

ContactUs
914.337.2005

Technologies d'emballage et inspection

PTI propose des systèmes d'inspection pour les tests d'étanchéité des emballages, l'intégrité des joints et les tests d'intégrité de la fermeture des conteneurs (CCIT). Nos technologies excluent la subjectivité des tests de colis et utilisent des méthodes de test conformes aux normes ASTM. Les technologies d'inspection de PTI sont des méthodes de test déterministes qui produisent des données quantitatives sur les résultats des tests. Nous sommes spécialisés dans l'offre d'une solution complète, y compris le développement de méthodes de test et la validation des équipements.

Contactez-nous

 

Technologies d'emballage et inspection

PTI propose des systèmes d'inspection pour les tests d'étanchéité des emballages, l'intégrité des joints et les tests d'intégrité de la fermeture des conteneurs (CCIT). Nos technologies excluent la subjectivité des tests de colis et utilisent des méthodes de test conformes aux normes ASTM. Les technologies d'inspection de PTI sont des méthodes de test déterministes qui produisent des données quantitatives sur les résultats des tests. Nous sommes spécialisés dans l'offre d'une solution complète, y compris le développement de méthodes de test et la validation des équipements.

ptiusa

Nos technologies sont conformes aux normes ASTM et autres normes r�glementaires.

ContactUs
914.337.2005

Contactez-nous

 
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