US Instrument specialist Mocon has launched Pac Check 650 EC, a packaging headspace analyser that, it says, can help pharma manufacturers find the right oxygen/carbon dioxide balance to support shelf life and drug efficacy goals.
The limited headspace found in common pharmaceutical product packs like ampoules, vials and syringes, which can be less than one cubic centimetre, makes accurate assessment of the gaseous mix problematic.
A spokesperson for the Minneapolis firm told in-PharmaTechnologist that the Pac Check 650 EC was designed to address this problem across all stages of the process from package development to supply chain assessment.
“Drug companies spend tens of thousands of Euros investing in high tech equipment designed to displace the presence of oxygen and add-in elevated levels of carbon dioxide for the purposes of controlling product efficacy.
“Our instrument validates the performance of the gas flushing operation of this technology to provide assurance that product quality standards are realised.”
She added that industry customers had approached it asking for an instrument that was both cost effective to install and easy to maintain and service in-house, which is why the unit features Mocon’s one-button Cal-Smart calibration technology.
“The calibration of instruments is perhaps the most vexing of downtime experienced by operators and certified tank gas is expensive. Cal-Smart allows the operator a fast effective, economical O2 calibration at the touch of a button, without the cost and time required to calibrate using certified tank gas.”
The spokesperson also said that Mocon has developed a proprietary test method to be used when testing multiple packs, as is often required during small headspace analysis, that minimises the risk of the instrument being contaminated by the drug product being examined, further reducing maintenance expenditure.
The Pac Check 650 EC is already being used by several global drugmakers according to the firm, although further details are not being released for reasons of client confidentiality.