Beckman Coulter Life Sciences has announced that the MET ONE 3400+ portable air particle counter is now available to help GMP cleanroom users simplify their routine environmental monitoring and improve data integrity.
Lighter and "whisper-quiet," the new instrument enables users to import their Standard Operating Procedure (SOP) routine environmental monitoring maps and sampling configurations into the counter itself. This helps reduce human error, which can improve data integrity. All electronic records inside the counter are reviewed and approved - using electronic signatures - via a web browser, then exported via Ethernet. In addition, Administrators can remotely manage SOP version control using a web browser.
"Because everything is 'in the box,' managing even the most complex SOPs can be greatly simplified," said Senior Product Manager Carter Moursund. "Using a web-browser interface, our customers can customize their electronic SOPs and maps, and change or update them quickly and easily. Plus, thanks to a new 'plug-n-play' networking feature, all SOP modifications are automatically replicated on all counters the customer is using.
"What's more," he continues, "interactive, on-screen tracking instantly shows on-site users which locations have been sampled so they can monitor their progress at a glance."
After on-site monitoring professionals "sign" sampling reports via their electronic signature, reports can be exported in a secure electronic format to the customer's network or to a USB device. Thus, the MET ONE 3400+ supports compliance with the FDA's 21 CFR Part 11 regulation, and it can help make data access fast and efficient during audits required to maintain GMP manufacturing status.
In addition, facility managers can always review their environmental monitoring data, including all sample results and alarms, via secure web access. No external software is required to use a fleet of MET ONE 3400+ counters.
"We're serious about ensuring data security and integrity," Moursund said. "All data produced by the instrument is encrypted, and users are never permitted to delete sampling records for any reason."
"And we're just as serious about making the new 3400+ model even more user-friendly," he added. "We designed it to be lighter so it's easier to carry from location to location. The 10-inch touchscreen is highly sensitive so data entry can be trouble-free even when users are double-gloved. And an optional barcode reader can further expedite data entry and minimize potential errors."
Cleaning the instrument is faster and easier, too, according to Moursund, because the stainless steel case is completely sealed, which means customers can lightly spray cleaning solutions directly onto it.
"To help simplify cleanroom monitoring for FDA and GMP compliance," he said, "we've not only put a lot of valuable time-saving features into the box, we've made the box itself easier to use, carry and clean."