Dyna Scan Operation and Calibration SOP (QC)

In short: This example SOP describes how a QC analyst operates a Dyna Scan, an illuminated viewing chamber with a magnifying glass used to inspect printed foils and small print, and how its light intensity is checked monthly with a lux meter. Adapt every value to your own quality system and the instrument manual.

1. Objective

To describe the procedure for operating the Dyna Scan and for checking its light intensity.

2. Scope

This example SOP applies to the Dyna Scan used for visual inspection of printed or plain foils and printed matter with small font in the Quality Control department. Use it as a template under your own quality system.

3. Responsibility

• Analyst / Section Head (or designee): follow this SOP.
• Head of Quality Control (or designee): ensure the SOP is implemented.

4. Procedure

4.1 Preliminary check

Check that the equipment is clean and suitable for use.

4.2 Basic operation

The Dyna Scan is used to inspect printed or plain foils and printed matter with small print under illumination and magnification.

1. Switch on the mains.
2. Switch on the viewing-chamber illumination (switch on the extreme right of the equipment).
3. Place the sample on the glass of the viewing chamber.
4. View the sample through the round magnifying glass fixed above the chamber.
5. If more light is needed, switch on the additional illumination switch next to the viewing-chamber switch.
6. Press the switch on the round viewing glass to start its illumination.
7. Switch off all illumination switches after use.
8. Switch off the mains.

Note: Use the additional illumination only when needed and switch it off immediately afterwards.

4.3 Calibration (light intensity check)

Frequency: monthly (example in-house criterion).

Measure the light intensity of the viewing chamber and of the viewing glass with a calibrated lux meter (obtained from the Engineering department). The lux meter itself must be within its calibration due date; see SOP for calibration.

4.3.1 Measuring the viewing chamber

The steps below follow one example lux meter model. Follow the manual of the meter you use.

1. Switch on the lux meter.
2. Set the range switch to the range that suits the reading (example: 2000 to 19990 lux), the unit switch to lux, and the response time switch to the slow position.
3. Hold the sensor facing the light source.
4. Read the intensity on the display.
5. Slide the data-hold switch to freeze the reading.
6. Apply the multiplier and the light-source correction factor stated for the meter and lamp (example in-house criterion: multiply by 10, then by 0.98 for the fluorescent source) to get the intensity in lux.
7. Record the result on the calibration data sheet.
8. Release the data-hold switch and switch off the lux meter.

4.3.2 Measuring the viewing glass

Repeat steps 1 to 8 above at the viewing glass.

4.4 Acceptance criteria

Light intensity should be not less than 1000 lux (example in-house criterion).

If the intensity is below the limit, have the Engineering department replace the light source and repeat the check. If the lux meter shows “LOW BAT”, inform Engineering to replace its battery.

Record the check on the data sheet and, if out of limit, raise a deviation; see Handling of incidents and deviations.

5. Training

• Trainer: Head, Quality Control
• Trainees: QC chemists and section heads

6. Distribution

• Controlled copy 1: Head of Department, Quality Assurance
• Controlled copy 2: Head of Department, Quality Control
• Master copy: Head, Quality Assurance

7. Annexure

Annexure I: Calibration data sheet for Dyna Scan.

Records of operation and calibration should be kept at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, section 4.11; 21 CFR 211.180(a)), and longer if local law or the marketing authorisation requires.

8. Abbreviations

• SOP: Standard operating procedure
• QC: Quality Control
• NLT: Not less than

9. Revision history

References

• Instrument manufacturer’s manual for the Dyna Scan and the lux meter.
• European Commission. EudraLex Volume 4, EU GMP Part I, Chapter 4: Documentation, section 4.11.
• US FDA. 21 CFR 211.180: General requirements.