New 3400+ Particle Counter
The 3400+ series with built-in embedded Clarity Software is the most versatile portable particle counter on the market with an intuitive user interface for a wide range of cleanroom applications – from process trouble shooting to continuous monitoring in an aseptic production environment.
Applications
The 3400+ is used in applications like cleanroom qualification in accordance with ISO 14644- 1: 2015 and EU-cGMP and for continuous cleanroom monitoring of isolators and RABS. The 3400+ series make use of an open communication architecture for seamless integration into any environmental monitoring systems like Envigil-FMS or any other third party monitoring software. The 3400+ is designed to meet all of today’s requirements related to data integrity and connectivity, it really helps the users to improve their Data Integrity Compliance according to the FDA-ALCOA acronym.
Simplified, secure data management eases audits
The MET ONE 3400+ helps you manage accurate cleanroom monitoring data via safe and secure internal software and web access—there’s no external software needed. All data is encrypted, and users are never permitted
to delete records. And because it uses Microsoft Active Directory for Username and Password Control for log-on and electronic signatures, it supports 21 CFR Part 11 compliance and ALCOA guidance.
SOP Version Control
Never was it easier to manage your SOP version control due to the Embedded Clarity software which facilitates SOP version control directly from your PC and a remote connection to the particle counter connected to the same LAN network. User management has also been improved and can be managed via LDAP (Lightweight Directory Access Protocol). This way user rights can be easily managed by the central IT department using Microsoft Windows Active Directory username and password control. The counter is standard equipped with a robust WiFi antenna and web browser interface which can be connected to the corporate WLAN network to…
# store data on the secure network drive on the server
# print the results directly on a network printer
# review and approve the data via the browser interface including digital sign off
Easy to work with
Identical web browser experience to instrument for SOP configuration, user management, or training through a projector. An instrument can be installed into a remote location and fully controlled for sampling via the remote web interface, allowing for central control or remote operation in areas where technicians are not permitted. Sensitive, 10-inch touchscreen enables reliable data entry even when users are double-gloved. Optional barcode reader expedites data entry and minimizes potential for operator errors.
Easy to Clean and disinfect
The 3400+ has a sealed touchscreen and 316 stainless steel enclosure, which allows for spraying with cleaners (VHP, bleach, alcohol) directly onto the instrument. The 3400+ is standard delivered with:
Stainless steel 316 housing
2 batteries
power supply 24VDC
isokinetic probe (aluminum)
± 3 meters of Hytrel sample tubing
a cleaning Brush
Upload your Floorplan
Our new MET ONE 3400+ Series Portable Airborne Particle Counter features automated integrated electronic SOPs and sampling maps that reduce training requirements—and sampling errors. Floor plans can be uploaded to the particle counter and locations can be marked on the sampling floor plan.
New 3400+ Portable Particle Counter
21 CFR part 11 Compliance
Secure Electronic Records
Microsoft Active Directory user control
Filterable Audit trail
Multiple Unit control via web browser
Web browser control over multiple units
SOP version control
Easy to Clean
Easy to Use
Review and Approve directly via web browser
Secure Electronic Records
An electronic signature is attached to all approved final reports, which can then be exported in secure electronic format.
Filterable Audit trail built-in
A GMP grade audit trail is included in the instrument, including information on logins, logouts, power events, sampling, electronic signatures, SOP updates, and other critical actions taken on the instrument. Built in filtering and reporting simplifies review and approval of audit events by the QC manager.
Review and Approve
Supervisors can log-on to the instrument via a web-browser to review sampling results, alarms and comments and approve the final electronic record, attaching their electronic signature. Digital signatures fully compliant with Annex 11 and 21 CFR part 11 can be used to sign for modifications in SOP’s or to add sample comments.
