"Initiatives such as FDA's Process Analytical Technology program are making the need for stringent, consistent and traceable quality controls more critical than ever," said Kirby Pilcher, president, ARTEL.
There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance.
These tools, when used within a system can provide effective means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge.
As a result of this collaboration, Caliper will now conduct in-house testing on its automated liquid handlers, such as the Sciclone and RapidPlate, using ARTEL's Multichannel Verification System (MVS).
"Caliper and >ARTEL have teamed up to provide laboratories with an effective and convenient tool to document instrumentation verification from the factory to the laboratory and through the life of the product," he said.
ARTEL's MVS is a laboratory tool that can be used bench-top to accurately and precisely verify automated liquid handling performance in minutes.
It aims to give end-users the option to optimise liquid handling equipment using the same methodology as the equipment manufacturer. This provides a standard assessment technology to streamline service visits, facilitate process adjustment and enhance data integrity.
The system relies on dual-dye ratiometric photometry to verify low volume measurement with a high degree of accuracy and precision.
Verifying the performance of each automated liquid handler prior to distribution ensures that Caliper's customers receive equipment working to specification.
"This partnership provides life science laboratories with an objective quality assessment and the latest technology for equipment optimisation," said Pilcher.
The FDA's Process Analytical Technology (PAT) Initiative is a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.
Once Process Analytical Technology (PAT) has FDA regulations it will be the most significant change to regulation in years.
It will allow US drug manufacturers to update old technology and approaches to drug manufacturing.
Process Analytical Technology (PAT) includes chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner but physical properties is a core element of PAT.
It has been described as the pharmaceutical industries drive to provide real-time information to characterize and control process variation and manufacturing capability.
PAT requires a true understanding of the processes and unlike current QA testing the results derived from PAT may not be consistent from day-to-day.