PARTICLE COUNTER APEX Z
Light particle counter with 6 particle size channels from 0.3 µm and sample flow rate up to 100 l / min. In addition to clean room qualification according to ISO 14644-1, the Apex Z particle counter is suitable for continuous particle monitoring in accordance with EU GMP Annex 1 thanks to the LED alarm indicator built into its handle.
LIGHT AND INNOVATIVE
THE NEW PARTICLE COUNTER APEX Z
The Apex Z particle counter from Lighthouse Worldwide Solutions sets new standards in the continuous monitoring and periodic classification of cleanrooms in accordance with ISO 14644-1, EU GMP Annex 1 or FS-209E. The device is characterized by innovations such as the alarm indicator integrated in the handle, multi-touch screen, Wi-Fi radio module and hot-swap batteries with up to 11 hours of runtime. The integrated user management in combination with the Audit Trail ensures conformity to 21 CFR Part 11.
The housing is easy to wipe and is chemically compatible with common cleaning and disinfecting agents, including VHP (evaporated H2O2).
HARDWARE FEATURES
LIGHTEST 1 CFM & 100 LPM PARTICLE COUNTER
Weight is an important factor when working with mobile particle counters. The Apex Z with battery weighs just 4 kg, half as much as comparable particle counters from other manufacturers. With its small dimensions (32.41 x 15.82 x 22.55 cm), the Apex Z is ideal for sampling in and classifying clean rooms.
HANDLE ALARM INDICATOR
The status display integrated in the handle informs the user about the status of the particle counter during sampling and notifies him of alarm limit violations. Ideal when using the particle counter for continuous particle monitoring in accordance with EU GMP Annex 1, which requires real-time information from the operator.
QUIET AND ROBUST PARTICLE COUNTER
The Apex Z conveys the measurement volume using an internal blower, is hardly audible acoustically and is therefore also suitable for applications in quiet environments, e.g. in isolators. The robust housing is easy to wipe and is chemically compatible with common cleaning and disinfectants agents, such as VHP (evaporated H2O2).
SOFTWARE FEATURES
DATA SECURITY & INTEGRITY
Apex Z ensures conformity of every data record thanks to the latest real-time self-diagnosis. Data integrity is guaranteed by various user and security levels, the audit trail in the device as well as in the download software and with data tags that record batch information, room status or other information that is critical for particle counting.
REPORTS ACCORDING TO CURRENT REGULATIONS
Clean room certification reports according to FS 209E, ISO 14644-1: 1999, ISO 14644-1: 2015, & EU GMP are generated on the screen, via the printer, via app or in the extensive 21 CFR Part 11 compliant download software. Regular firmware upgrades ensure that the device remains up to date with the regulations.
AUTOMATED USER GUIDE
The menu shows the rooms and their sampling points cartographically for periodic particle monitoring and clean room classification. That way, errors can be avoided, progress can be seen at a glance and, if necessary, the usual sequence of numerous sampling points can be changed without losing the overview.
APP FOR APEX Z REMOTE CONTROL
An App enables direct communication with one or more Apex Z particle measurement devices from a smart phone, tablet or PC.
INTEGRATION IN THE CLEANROOM MONITORING SYSTEM
The Apex Z particle counter was also designed for continuous clean room monitoring. Thanks to the possibility of sending data wirelessly via Wifi or Bluetooth to a computer or server, the Apex Z can be used as a wireless real-time sensor. Bakrona offers customer-specific integration and automation solutions for clean room monitoring systems.
SPECIFICATIONS
- 6 particle size channels, measures from 0.3 µm
- Compliant with ISO 21501-4, calibration according to ISO 21501-4
- Flow path and housing resistant to VHP / H202
- Sample flow rate up to 100 l / min
- Built-in, low-noise pump; HEPA output filtered
- Configurable and colored LED alarm indicator built into the handle
- Autonomous operation up to 11 hours (with 2 Li-ion batteries), 4 hours charging time
- Touchscreen: multitouch, color, 1200×800 pixels, 17.8 cm
- Built-in thermal printer
- Communication: USB, Wi-Fi (802.11 a / b / g / n), Ethernet
- USB interface for data download (CSV or encrypted)
- Connection for digital temperature / humidity sensor
- App (Android) for remote control and management of several Apex Z particle counters
- Self-diagnosis of laser, flow and detector electronics
- Report assistant for classification reports FS209E, ISO 14644-1: 2015 and EU GMP Annex 1
- Batch / Lot data identification and tagging
- Data storage for 10,000 data records, 999 measuring locations, 50 rooms, 100 measuring recipes, 100 reports
- Security function with a maximum of 25 users, 3 user groups
- Complete audit trail with max. 20,000 records, exportable
- Device configuration closing via app or USB
- Dimensions: 33 x16 x23 cm, 3.2 kg (3.8 kg with 1 battery)
- Polycarbonate housing, antistatic
- 2 year guarantee
