Connect 2 Cleanrooms develops validations further with Particles Plus technology

Since the installation and validation team from Connect 2 Cleanrooms has been performing particle counts for cleanroom validations with Particle Plus particle counters, the installation and validation manager, Mark Jackson, has observed an increase in efficiency during validations.

As an example, he cites a cleanroom for which nine validation locations require counts. Typically, locations are numbered sequentially. For example: Locations: 1-3 (Row 1), 4-6 (Row 2), 7-9 (Row 3). With the Particle Plus handheld devices for particle counting, you can change the order of the locations to find the fastest route through the cleanroom, thereby increasing efficiency and reducing turbulence.

The automatic switching function allows the validation technician to automatically move to the next programmed location. Additionally, a delay can be configured to allow the device to be moved away in time, preventing contamination of the count.

"The Particle Plus handheld devices are user-friendly, intuitive, and robust," said Jackson. "Our technicians can program them safely to perform the most efficient validation route."

They can also train our customers in best practice methods. Companies should ideally use a particle counter for regular testing to ensure that the cleanroom's performance meets the parameters of the relevant ISO classification."

Graphical representations are created as an optical display of the particle count over time, showing the number of particles per second on a graph with p/s (Y-axis) versus time (X-axis). For complete transparency, peak values can be recorded, and comments such as "Door opened" or "Damaged seal" can be saved.

"If an unprecedented event occurs that causes the particle count to increase, operators can exclude such data if necessary," Jackson adds. "However, according to ISO 14644 standards, only one exclusion is allowed, or the test is validated to protect integrity."

The technology of these Particle Plus devices is what makes them particularly special on the market. After entering the cubic volume of the cleanroom, the device calculates the number of locations and sample sizes required to meet ISO 14644 requirements (GMP or Federal Standard can also be calculated). Furthermore, the device suggests relevant particle sizes to consider.

Up to 50 custom recipes can be set with different sample sizes, delays, location times, etc. For Connect 2 Cleanrooms, this means they can be used to store different locations for customers who perform regular validations.

Measurements can also be specified in metric or imperial units for extrapolation of raw data, giving them an international standard.

With multiple options for data extraction, the data flow can be determined via the desired communication protocol of the organization, rather than being limited by the device's capacity.

Modbus TCP/IP is available as standard (Modbus 485 and 232 are additional options). However, only Particle Plus devices offer wireless transmission over Wi-Fi (optional) as well as USB to PC or USB stick.

The particle counters can store up to 45,000 data sets simultaneously. This amount is sufficient for continuous particle counting (a series of 1-minute samples without interruption), conducted over a period of 33 days without additional data downloads.

This capability means that the data of Connect 2 Cleanrooms customers is protected before download and cannot be overwritten. The data is timestamped to enable complete traceability after extraction.

Using multi-core processors, the patented technology offers simultaneous interface sessions, which protect data collection and prevent sampling interruptions.

Also patented is the remote diagnosis and configuration technology, enabling quick troubleshooting of machine data, pump data, laser runtime, etc., without sending the device for repair. The performance of the intelligent batteries can also be analyzed via the remote diagnostics tool, down to individual cells and battery temperature.

Jackson explains that the Li-ion batteries provide technicians with enough power to operate the devices for an entire week without recharging. A fully charged battery allows for uninterrupted sampling for 10.5 hours. The display is operated at full brightness in this calculation. If the display brightness is dimmed and other power-saving measures are taken, the runtime could be extended even further. The device indicates how much additional battery life can be achieved through these changes. Employees relying on battery performance will welcome this message, as it eliminates power outages during validation.

The counters feature symbol-driven menus and a large 4.3-inch color display with a touchscreen interface, fully meeting today's device user requirements. Mark Jackson particularly appreciates the intuitive grouping of symbols and the ability to expand elements such as graphics with a single click. A gentle touch shows the calibration date, allowing the technician to quickly verify whether the device is calibrated.

The convenient handle allows ergonomic control, and the rugged housing includes a laser-cut foam to protect the device during transport. It contains accessories such as a cleaning filter to enable cleaning after use in dirty or toxic environments. A temperature and humidity sensor is also included. An integrated HEPA filter on the exhaust ensures that no particles are released back into the cleanroom during sampling.

Spot monitoring is enabled via the Real-Time Meter™ function. If contamination occurs in a cleanroom due to a damaged seal or perforated filter, the devices alert the user through a visual real-time graphic with adjustable sensitivity, showing the maximum particle count per second during sampling, indicating the source of contamination.

The handheld devices can also be used as continuous monitoring systems, as they can connect to a network and stream real-time data to a PC desktop or remote query over the internet via an IP address.

"This gives organizations confidence that their cleanrooms always meet the standards for which they were designed, even between validation visits," Jackson concludes.

Particle Plus particle counter handheld devices are available from £2,128 and can be ordered online at www.cleanroomshop.com.