The Picarro PI2114 gas concentration analyzer continuously measures H2O2 levels as low as 3.3 ppb to help avoid drug oxidation and safeguard drug stability
SANTA CLARA, California, Sept. 7, 2017 /PRNewswire/ --Picarro Inc., a leading provider of gas concentration and isotope analyzers and systems for industrial and science applications, announces the introduction of the Picarro PI2114 hydrogen peroxide gas concentration analyzer for GMP pharmaceutical manufacturing. The PI2114 analyzer provides continuous, real-time measurement of hydrogen peroxide levels as low as 3.3 parts-per-billion (ppb) to help avoid oxidation and safeguard drug stability in high-potency API and biologics manufacturing and in aseptic fill and finish. It combines best-in-class performance, GMP compliance, and cost-saving features for fast, easy installation and operation with minimal operating costs.
"Major pharmaceutical, CMO, and isolator companies have used Picarro hydrogen peroxide analyzers for a decade to ensure ultra-low levels of residual hydrogen peroxide after sterilization and decontamination of isolated manufacturing environments," said Jan Willem Poelmann, Picarro senior vice president of sales and marketing. "The PI2114 analyzer incorporates capabilities that will enable new customers to quickly and easily achieve installation and operation compliant with GMP manufacturing standards."
For more information about the Picarro PI2114 hydrogen peroxide gas concentration analyzer, go to www.picarro.com/pharma.
PERFORMANCE
Continuous, real-time hydrogen peroxide (H2O2) monitoring
Lower Detection Limit: 3.3 ppb
Precision: 1.1 ppb
Response Time @ 1 ppm: <1 minute (Rise and fall times, 10 - 90% and 90 - 10%)
GMP COMPLIANCE
21 CFR Part 11
Installation and Operation Qualification
Fast, easy validation with commercially available surrogate gases
COST-SAVING FEATURES
No wet chemicals or consumables required
No moving parts for infrequent maintenance
Long-term stability for infrequent calibration
