Applications

Vials

Vials, both glass and polymeric, are widely used for high-potency drugs, necessitating reliable helium leak detection to ensure package integrity and prevent microbial ingress. Helium-based methods, known for their sensitivity, are essential for quality control, validating assembly lines, and assessing vial performance under varying conditions, including cold storage.

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Prefilled Syringes

Prefilled syringes, crucial for advanced injectable drugs and self-administration, present complex sealing and functionality challenges requiring thorough Container Closure Integrity (CCI) evaluations. Helium leak detection with the SIMS 1915+ offers precise, custom tooling to measure seal integrity, ensuring robust package quality.

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Bottles

Bottles in the health sciences industry vary in size and closure types, including screw tops, elastomeric liners, and induction seals, with a growing need to test sterile bulk containers and APIs due to increased transport and outsourcing. PTI specializes in engineering solutions for testing these containers using helium leak detection, ensuring optimized sealing and assembly.

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Blister packs

Helium-based testing for blister card integrity is highly effective due to its extreme sensitivity, detecting helium escaping through micro-channels when a vacuum is applied. PTI offers expertise in custom designing test chambers and developing suitable methods for various blister card sizes and materials, ensuring accurate and reliable results.

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Foil pouches

Foil pouches face unique challenges in integrity testing due to micro-voids caused during manufacturing and handling, which can be too small for the human eye to detect. Helium leak testing is highly sensitive, detecting these defects by measuring helium escape under vacuum, ensuring reliable quality control within 20-60 seconds per test.

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Combination products

Advances in drug delivery have led to the adoption of cartridge-based systems, for which helium mass spectrometry is well-suited, similar to vials and syringes. Customized fixtures for helium leak detection isolate specific cartridge areas, allowing for precise leak rate calculations and qualitative or quantitative results through the creation of a vacuum and detection of helium escape.

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914.337.2005

info@pti-ccit.com ContactUs

8 Skyline Dr, Hawthorne,
NY 10532, United States
Ph: 914.337.2005
info@pti-ccit.com

Applications

Vials

Prefilled Syringes

Bottles

Blister packs

Foil pouches

Combination products

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