Piscataway, NJ October 10, 2023 HORIBA, global leader in spectroscopy solutions, is excited to announce the launch of its new A-TEEM Compliance Package, designed to meet the regulatory requirements of the pharmaceutical industry.
The package offers a complete solution for record-keeping, method validation, and instrument verification that will meet GMP and Electronic Records requirements around the world.
The package is comprised of 3 elements:
- The EzPAT server, developed under OPC UA protocols, provides connectivity with common PAT enterprise platforms that are used to control process analytics while enabling regulatory compliance. Deployed on the HORIBA Aqualog®, EzPAT enables the OPC UA client to control A-TEEM data acquisition, analysis, and prediction as part of a larger environment that ensures regulatory control.
- Our A-TEEM Direktor multivariate analysis software is the first MVA package designed specifically for multidimensional A-TEEM data. It was developed with non-expert users in mind and provides a guided workflow that allows beginners to succeed quickly. Knowing that it may be deployed in a GMP environment, the software was developed following GAMP (Good Automated Manufacturing Practice) guidelines. It provides a complete audit trail, includes authentication by user login, and other controls needed to enable compliance with electronic records guidelines, such as 21 CFR Part 11.
- IQ/OQ documentation and qualification specifically designed to follow U.S. Pharmacopeia test methods and acceptance criteria ensure data reliability, reproducibility and meeting expected performance standards.
A-TEEM combines UV-Vis Absorbance-Transmittance with fluorescence Excitation Emission Matrix spectroscopies, and is faster, more sensitive, with lower detection limits than current PAT spectroscopic solutions. With this new compliance package, A-TEEM is the spectroscopic solution that can identify low level components in complex mixtures, flag contaminants, and identify out-of-spec product, with end-to-end coverage for a GMP environment.
“A-TEEM combines the sensitivity of separations with the speed of spectroscopy. It greatly expands the analytical toolbox for monitoring samples that have been challenging for PAT – like vaccines, ADCs, viral vectors, and exosomes,” said Linda Kidder, Ph.D, Life Sciences Business Development Manager with HORIBA. “With the addition of this compliance package, A-TEEM is able to move seamlessly from R&D to production.”
The A-TEEM Compliance Package will be launched at the upcoming SciX show in Reno, in mid-October and is commercially available. To receive updates on the package, or to contact a sales rep, please go to: https://scientific.us.horiba.com/compliance-package .
About HORIBA
Founded in 1953, HORIBA has explored a wide range of unique measurement and analysis technologies to meet global customer needs from group companies and local sites spread across 29 counties and regions. Under the corporate motto Joy and Fun, the company has expanded and refined its core technologies to solve society’s energy issues of today and tomorrow. Our unique measurement and analysis technologies are valued in various fields of society including the three megatrend business fields of Energy & Environment, Biology & Healthcare and Materials & Semiconductor. For more information on HORIBA, visit https://www.horiba.com/int/company/about-horiba/home/