HLT

Feasibility and Method
Development

HLT

Helium Leak Detection Feasibility Studies

PTI offers robust feasibility and method development services. Feasibility services can precede instrument purchase, proving proof of concept for its intended use, or help to expand existing capabilities by developing solutions for new package systems or study goals prior to acquiring an instrument or moving forward with outsourcing solutions.

In instances where clients do not have internal resources skilled at the development of helium leak detection tests, or to increase the capacity of existing resources, we also offer comprehensive method development using industry standard positive control practices. Our team and collaborative partners have hands-on experience required to ensure that the resulting methods meet or exceed all current regulator expectations. Methods developed at PTI can be transferred and validated at the client site or used routinely at PTI’s Center of Excellence for lab-scale, non-cGMP studies.

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