News And Announcements

PTI Introduces ETHOS 21 CFR Part 11 Compliant Software for Data Collection from SIMS 1915+ Helium Leak Tester

February 23, 2023

 

PTI Introduces ETHOS 21 CFR Part 11 Compliant Software for Data Collection from SIMS 1915+ Helium Leak Tester

Hawthorne, NY - February 23, 2023 - PTI, a leading provider of advanced leak detection and measurement solutions based in Hawthorne, NY, is proud to announce the release of its new ETHOS 21 CFR21 Part 11 compliant software for data collection from the SIMS 1915+ Helium Leak Tester. This software ensures compliance with FDA regulations for data collection, making it an essential tool for manufacturers in the industry.

 

Helium leak testing is a deterministic method of testing for sub-micron leaks in sealed systems, such as medical devices and pharmaceutical packaging, including ultra-cold storage CCI testing. It is widely used in the manufacturing process to ensure product quality and safety. The SIMS 1915+ Helium Leak Tester is a state-of-the-art instrument that can detect leaks as small as 1 x 10 -10 mbar-L/sec, making it one of the most sensitive leak detectors on the market.

 

About PTI

PTI is a global leader in the design and manufacturing of leak detection instruments and solutions. With almost 40 years of experience in the industry, PTI's products are known for their reliability, accuracy, and ease of use. The company's mission is to provide customers with the best possible solutions for their leak detection needs.

 

The new software for the 1915+ Helium Leak Tester is available for Immediate purchase, and PTI is offering training and support to ensure customers are able to fully utilize the software's capabilities.


 
ptiusa

Our technologies conform to ASTM and other regulatory standards.

Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

Sales Channel Partner Portal Login

Get in Touch

 

Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

Sales Channel Partner Portal Login

ptiusa

Our technologies conform to ASTM and other regulatory standards.

Get in Touch

 
Popup Popup