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SOP for Operation of Oscillating Granulator

Last reviewed 29 Oct 2026 · 4 min read

Contents
  1. 1. Objective
  2. 2. Scope
  3. 3. Responsibility
  4. 4. Procedure
  5. 4.1 Before assembly
  6. 4.2 Assembly
  7. 4.3 Operation
  8. 4.4 Equipment records
  9. 4.5 Calibration
  10. 4.6 Reporting abnormalities
  11. 5. Abbreviations
  12. 6. Training
  13. 7. Distribution
  14. 8. Annexures
  15. Frequently asked questions
  16. References

In short: This example SOP describes how production staff assemble, run and release an oscillating granulator for sizing wet or dry mass. It covers the screen and blade checks, the inch-mode test, feeding, labelling and the logs to complete. Adapt it to your own equipment and quality system.

This is an illustrative template. Speeds, screen sizes, intervals and label wording must be taken from your own approved batch manufacturing record (BMR), equipment manual and quality system.

1. Objective

To lay down a procedure for the operation of the oscillating granulator.

2. Scope

This SOP applies to the operation of the oscillating granulator in the granulation area of the manufacturing facility.

3. Responsibility

  • Production officer/executive: operates the granulator as per this SOP and the BMR, and records the activity.
  • Head of Production: ensures effective implementation of this SOP.
  • Quality Assurance: verifies line clearance and reviews the logs.

4. Procedure

4.1 Before assembly

  1. Confirm that the granulator, its parts and the room are clean and carry a valid “CLEANED” status label as per the cleaning SOPs.
  2. Take line clearance from QA as per the line clearance SOP. Before processing starts, the work area and equipment must be free of previous product, materials and documents not needed for the current batch (EU GMP Part I, Chapter 5, §5.50).
  3. Switch the main supply “OFF” before setting up the machine.

4.2 Assembly

  1. Fix the blades to the rotor and mount the rotor on the central shaft. Tighten it properly.
  2. Take the stainless steel (S.S.) screen specified in the BMR. Check that it is clean and intact (no tears, broken wires or loose mesh) and that its identification matches the BMR.
  3. Fit the screen on the base plate, mount the assembly on the granulator, close the screen cover and tighten the wing nuts.
  4. Place the belt on the pulley that gives the speed required by the BMR.
  5. Fix the hopper and affix the “IN USE” label with product name, batch number and date.

4.3 Operation

  1. Switch the main supply “ON” and start the granulator in “INCH” mode. Check that the blades move smoothly and in the direction required by the BMR.
  2. Place an empty drum with a polythene bag, or an S.S. bin with the appropriate label, below the granulator outlet.
  3. Feed the material into the hopper manually, in small portions. Do not push material in by hand while the machine is running.
  4. Check the quality (size and appearance) of the granules at the start and during the run, as required by the BMR.
  5. After the batch is complete, switch off the machine and affix a “TO BE CLEANED” label.
  6. Record the activity in the area and equipment usage and cleaning log.

4.4 Equipment records

Equipment must be cleaned and maintained so it does not alter the quality of the product, and a log of use, cleaning and maintenance must be kept (21 CFR 211.67 and 211.182). Logbooks and batch records are retained for at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, §4.11; 21 CFR 211.180(a)), longer if local law or the marketing authorisation requires.

4.5 Calibration

Calibrate the rotor speed (RPM) at a defined frequency. Example in-house criterion: every six months. Mechanical and electronic equipment used in production must be routinely calibrated, inspected or checked according to a written program, with written records of those checks (21 CFR 211.68(a)).

4.6 Reporting abnormalities

Report any abnormality in the working of the granulator (noise, vibration, damaged screen, loose parts) to the production officer immediately, stop the machine, and raise a deviation or breakdown record as per your quality system.

5. Abbreviations

TermMeaning
S.S.Stainless steel
SOPStandard operating procedure
RPMRevolutions per minute
BMRBatch manufacturing record
QAQuality Assurance

6. Training

  • Trainer: Head of Production or designee
  • Trainees: Production department staff

7. Distribution

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

8. Annexures

Nil

Frequently asked questions

Why start the granulator in inch mode? Short jogs let the operator confirm the blades move freely and in the right direction before the motor runs continuously, which avoids damage to the screen and rotor.

Why check the screen before every batch? A torn or loose screen can let oversized granules or metal fragments into the product. Checking integrity and identity before use protects both quality and safety.

Is the calibration interval fixed by law? No. The regulations require calibration at suitable intervals under a written procedure; the interval itself is set by your own risk assessment and equipment history.

See also: SOP for equipment cleaning in the production department and Good documentation practices of BMR and BPR.

References

  1. European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 5 “Production” (in operation 1 March 2015), §5.13, §5.21 and §5.50.
  2. European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 4 “Documentation”, §4.11.
  3. US FDA, 21 CFR 211.67 (equipment cleaning and maintenance), 211.68(a) (automatic, mechanical and electronic equipment), 211.180(a) (general requirements for records) and 211.182 (equipment cleaning and use log).
  4. Related in-house SOPs: equipment cleaning of the oscillating granulator; cleaning of S.S. sieves and screens; equipment and area cleaning and usage records; cleaning of cubicles.

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