METONE Laser Particle Counter SOP Guide

Step-by-step SOP for METONE Laser Particle Counter use in pharma cleanrooms with setup, operation, and safety tips.

SOP for METONE Laser Particle Counter

In pharmaceutical manufacturing, maintaining cleanroom standards is critical. The METONE Laser Particle Counter is widely used to monitor non-viable airborne particles and ensure compliance with classified area requirements.

This guide provides a clear, practical Standard Operating Procedure (SOP) to help users operate the instrument accurately and safely.

1. Objective

The objective of this SOP is to define the correct operation of the METONE Laser Particle Counter for consistent, error-free performance in cleanroom environments.

2. Scope

This procedure applies to measuring non-viable airborne particle counts in classified pharmaceutical areas such as cleanrooms.

3. Responsibility

• Execution: Technical Assistant / Executive
• Verification: Executive / Manager

4. Accountability

• Head of the Department

5. Procedure

5.1 Preparation

• Gather all required accessories and attachments.
• Place the METONE Laser Particle Counter in a clean environment.
• Assemble all components properly before use.
• Transfer the instrument carefully into the classified area.

5.2 Power Setup

• Connect the device to the main power supply.
• Switch ON both the mains and the instrument.

5.3 Zero Count Verification

• Attach the purge filter assembly to the sensor inlet tube.
• Perform a zero count test to confirm no contamination.
• If the reading is zero, proceed with actual measurement.

5.4 System Setup

Once powered on, the display shows particle size, count, and flow rate.

• Press F1 to access system setup.
• Configure the following parameters:

Setting	Value
Location	Set as required
Count Cycle	Set as required
Screen Mode	OFF
Run Mode	AUTO
Count Mode	CUM
Buffer	0000
Group	As required

Note: Group represents room ID/location.

5.5 Programming Steps

• Press PROG to modify settings.
• Use arrow keys to adjust values.
• Press ENTER to confirm each setting.

5.6 Timing Configuration

• Press F2 to access clock setup.
• Set:
  • Period: 1 minute
  • Hold Time: 5 seconds
• Verify current date and time.
• Press F4 to return.

5.7 Running the Test

• Attach the isokinetic probe to the inlet tube.
• Position it at the desired sampling location.
• Press RUN to begin the counting cycle.

5.8 Printing Results

• After completion, press F1 → Print Setup.
• Turn printer ON.
• Press F2 to print results.
• Press F4 to return.

5.9 Shutdown Procedure

• Switch OFF the instrument.
• Turn OFF the mains supply.
• Disconnect all attachments.

6. Additional Features

The METONE Laser Particle Counter can also measure:

• Air Velocity
• Relative Humidity (RH)
• Temperature

Attach the required probes when needed.

7. Precautions

• Never look into the inlet while the device is operating (risk of eye injury).
• Avoid sampling reactive gases like hydrogen or oxygen.
• Always operate in a controlled clean environment.

8. Abbreviations

• RH: Relative Humidity
• CUM: Cumulative Mode
• ID No.: Identification Number

Frequently Asked Questions (FAQs)

1. What is a METONE Laser Particle Counter used for?

It measures airborne particle concentration in cleanrooms to ensure compliance with pharmaceutical standards.

2. Why is zero counting important?

Zero counting ensures the instrument is free from contamination before actual measurement.

3. What does CUM mode mean?

CUM (Cumulative mode) records the total number of particles detected over time.

4. How often should the particle counter be calibrated?

Calibration is typically required annually or as per regulatory guidelines.

5. What is an isokinetic probe?

It ensures accurate sampling by matching air velocity at the inlet.

6. Can the device measure temperature and humidity?

Yes, with additional probes, it can measure RH and temperature.

7. What is the standard sampling time?

The SOP recommends a 1-minute sampling period.

8. Why should reactive gases be avoided?

Reactive gases can damage the instrument and pose safety risks.

9. What does “Group” represent in settings?

Group refers to the room ID or sampling location.

10. What should be done after completing measurements?

Turn off the device, disconnect attachments, and store it properly.