Page 1 of 3

QUALITY CONTROL DEPARTMENT

SOP no. PUN/SOP/Q/2.441 Preparation Date 14/09/2019
Supersedes PUN/SOP/Q/2.440 Effective Date 17/09/2019
No. of Revisions 2 Next Revision 16/09/2020
Product Zetasizer Brand Name Malvern
Model no. Nano-ZS-ZEN3600
TITLE: STANDARD OPERATING PROCEDURE FOR MALVERN ZETASIZER
(Nano-ZS-ZEN3600) PARTICLE SIZE ANALYZER

1. OBJECTIVE: To provide standard instructions for operation of Malvern Zetasizer (Nano-ZS-

ZEN3600)

2. SCOPE: The operation of particle size analyzer is to measure Particle size, Molecular weight and
Zeta potential.

3. RESPONSIBILITY:
3.1. QC analysts and related personnel are responsible for the implication of this procedure.
3.2. QA head is responsible for regular and required amendments in Standard operating procedure.

4. DISTRIBUTION LIST:

4.1. Srushti, Quality Control Head

4.2. Swetha, Production Head
4.3. Sakshi, Formulation and Development Head
4.4. Mitesh, Quality Assurance Head

5. REVISION HISTORY:
`
Version Date Person responsible Description of change
1.0 14/09/2018 Mitesh- QA Head -
2.0 14/09/2019 Mitesh- QA Head Revised cleaning procedure: clean the
instrument with a clean de-dusting cloth only.

6. ABBREVIATIONS:
6.1. QC Quality Control

Prepared by: Reviewed by: Approved by:

Signature

Name Prashanth Ankita Mitesh

Designation QA Executive QA Manager QA Head
 Page 2 of 3

QUALITY CONTROL DEPARTMENT

SOP no. PUN/SOP/Q/2.441 Preparation Date 14/09/2019
Supersedes PUN/SOP/Q/2.440 Effective Date 17/09/2019
No. of Revisions 2 Next Revision 16/09/2020
Product Zetasizer Brand Name Malvern
Model no. Nano-ZS-ZEN3600
TITLE: STANDARD OPERATING PROCEDURE FOR MALVERN ZETASIZER
(Nano-ZS-ZEN3600) PARTICLE SIZE ANALYZER
6.2. QA Quality Assurance
6.3. SOP Standard Operating Procedure
6.4. IPA Isopropyl Alcohol

7. PRECAUTIONS:
7.1.1. Make sure to switch off the instrument when not in use.
7.1.2. Cells should be cleaned prior to use. All size and Zeta potential cells should be rinsed/
cleaned with filtered dispersant before use.
7.1.3. The cell should be filled slowly to avoid air bubbles. Ultrasonication can be used to remove
air bubbles, but only if the sample is suitable for use with ultrasonics.
7.1.4. When using syringe for the dispersant, never use the first few drops from the syringe to avoid
contamination of dispersant by residual dust particles.
7.1.5. Hold the cuvette from the top to prevent tampering with the measurements and wipe the sides
with clean tissue.

8. PROCEDURE
8.1.1. Turn ON the instrument and wait for 1 hour for the laser to stabilize.
8.1.2. Start the Zetasizer software.
8.1.3. Choose the appropriate for the measurement. Organic solutions can only be measured in
glass cuvette.
8.1.4. Fill the cuvette to the depth of approximately 1cm.
8.1.5. Make a new Measurement File, then select Measure  Manual.
8.1.6. Click to Measurement type to choose the experiment type.
8.1.7. Click on sample and choose the name and write any notes as needed.
8.1.8. Click on Sample Material and choose your sample material from the list.
8.1.9. You may add a new material if the Refractive index is known.
8.1.10. Choose a dispersant or add new as needed.

Prepared by: Reviewed by: Approved by:

Signature

Name Prashanth Ankita Mitesh

Designation QA Executive QA Manager QA Head
 Page 3 of 3

QUALITY CONTROL DEPARTMENT

SOP no. PUN/SOP/Q/2.441 Preparation Date 14/09/2019
Supersedes PUN/SOP/Q/2.440 Effective Date 17/09/2019
No. of Revisions 2 Next Revision 16/09/2020
Product Zetasizer Brand Name Malvern
Model no. Nano-ZS-ZEN3600
TITLE: STANDARD OPERATING PROCEDURE FOR MALVERN ZETASIZER
(Nano-ZS-ZEN3600) PARTICLE SIZE ANALYZER
8.1.11. Temperature: at least 120s equilibrium time should be allowed since the room is very cold.
8.1.12. Cell type: choose a category and model.
8.1.13. Measurement: duration and repetitions may be adjusted.
8.1.14. Press OK to accept the Measurement settings.
8.1.15. Load the sample and press Start.
8.1.16. To view the data, select a measurement and look through the tabs (e.g. intensity or volume
PSD).
8.1.17. On a particular tab select Edit  Copy Size Values/ Graph.
8.1.18. Then data can be transferred to excel spreadsheet.
8.1.19. Turn off the instrument.

9. CLEANING AND MAINTENANCE

9.1. Switch OFF the instrument.
9.2. Switch OFF the mains for power supply.
9.3. Clean the instrument with a soft de-dusting cloth.
9.4. Care must be taken that samples are not split on the instrument or in the cuvette chamber.

10. REFERENCE:

10.1. Rawi, F. M. (2016). SOP for Malvern Zetasizer (Basic). (January 2014).
https://doi.org/10.13140/RG.2.1.3285.1440

Maintain log book as per the prescribed format

NOTE: In case of any difficulty or malfunctioning, inform the reviewer or approver.

Prepared by: Reviewed by: Approved by:

Signature

Name Prashanth Ankita Mitesh

Designation QA Executive QA Manager QA Head