Capsule: SOP for Monitoring Granulation Temperature and Humidity – V 2.0

Auditor

1 week ago

Standard Operating Procedure for Monitoring Granulation Temperature and Humidity

Department	Capsule Manufacturing
SOP No.	SOP/CM/084/2025
Supersedes	SOP/CM/084/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to provide a standardized procedure for monitoring temperature and humidity during the granulation process. Maintaining optimal granulation conditions is essential for ensuring the consistency and quality of the granules, which directly impacts capsule fill uniformity and product quality.

2. Scope

This SOP applies to all granulation processes in capsule manufacturing, including wet and dry granulation. It covers the steps required to monitor and control temperature and humidity within the granulation environment to ensure the integrity of the granules.

3. Responsibilities

Production Operators: Responsible for continuously monitoring temperature and humidity during the granulation process, ensuring that they are within the specified ranges.
Quality Control (QC) Team: Responsible for reviewing the temperature and humidity records, performing periodic checks, and ensuring that the granulation conditions comply with required specifications.
Quality Assurance (QA) Team: Ensures that the monitoring process aligns with GMP guidelines and internal quality standards. Reviews temperature and humidity records and approves them before batch release.
Maintenance Team: Responsible for ensuring that the equipment used to monitor temperature and humidity is calibrated and functioning correctly.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that temperature and humidity are monitored correctly during granulation and that any discrepancies are addressed promptly. The QA Manager is responsible for ensuring that the granulation environment complies with regulatory and internal standards.

5. Procedure

5.1 Preparation for Granulation Process

Before starting the granulation process, the following steps must be completed to ensure proper monitoring of temperature and humidity:

Verify Granulation Parameters
1. Ensure that the required temperature and humidity ranges for the granulation process are defined based on the formulation and batch specifications.
2. Confirm that the equipment required for temperature and humidity monitoring is calibrated and ready for use.
Prepare Monitoring Equipment
1. Verify that temperature sensors and humidity meters are installed and functioning correctly in the granulation area. Ensure that sensors are properly calibrated according to equipment guidelines.
2. Check that the recording devices or data loggers are connected to the monitoring equipment and set to capture data at the required frequency.
Prepare Granulation Materials
1. Ensure that all materials for granulation, including excipients and APIs, are pre-weighed and ready for processing.

5.2 Monitoring Granulation Temperature and Humidity

During the granulation process, continuously monitor the temperature and humidity as follows:

Monitor Temperature
1. Measure the temperature of the granulation equipment and environment to ensure it stays within the defined acceptable range, typically between 25°C and 40°C, depending on the formulation.
2. Monitor the temperature of the granulating solution or granulator during the process to ensure uniformity and avoid overheating.
3. Adjust the heat settings on the equipment if the temperature deviates from the specified range. Document any adjustments made during the process.
Monitor Humidity
1. Measure the relative humidity in the granulation room to ensure it remains within the specified range, typically between 30% and 60%, depending on the granulation method.
2. Monitor the humidity of the granulating solution or the air in the granulation chamber, adjusting the humidity control settings if necessary.
3. If the humidity falls outside the acceptable range, adjust the humidity control equipment or temporarily stop the granulation process until the conditions are corrected.
Data Logging and Documentation
1. Record the temperature and humidity data at regular intervals, ensuring that the data is logged in real-time or periodically during the granulation process.
2. Document any deviations from the defined ranges and the corrective actions taken in the batch production record (BPR).

5.3 Managing Deviation in Temperature and Humidity

If the temperature or humidity deviates from the specified range during the granulation process, the following actions must be taken:

Identify the Cause
1. Investigate potential causes of the deviation, such as equipment malfunction, incorrect settings, or environmental changes.
2. Review the granulation machine settings and environmental controls to identify any discrepancies.
Correct the Deviation
1. Adjust the equipment settings to bring the temperature and humidity back within the acceptable range.
2. If necessary, halt the granulation process temporarily to correct the deviation and avoid compromising the batch.
Document the Deviation
1. Document the deviation in the deviation log, including the cause, corrective action, and impact on the granulation process.
2. Review and approve the corrective action with the QA team before resuming production.

5.4 Post-Granulation Monitoring

After the granulation process is complete, ensure that the following actions are performed:

Final Temperature and Humidity Check
1. Perform a final check of the temperature and humidity after the granulation process to ensure that the conditions remain stable and that the materials are properly processed.
Record Final Data
1. Record the final temperature and humidity readings in the batch production record (BPR), ensuring the data is complete and accurate.
Release Data for Review
1. Submit the temperature and humidity data for review by the QC and QA teams to ensure compliance with quality standards and regulatory guidelines.

5.5 Equipment Maintenance

After completing the granulation process, perform the following maintenance tasks to ensure that the monitoring equipment is ready for future use:

Clean Monitoring Equipment
1. Clean the temperature and humidity sensors according to the manufacturer’s guidelines to prevent residue buildup that could affect accuracy.
Inspect Equipment for Wear and Tear
1. Inspect the monitoring equipment for signs of wear or damage and schedule repairs or replacements if necessary.
Calibrate Monitoring Equipment
1. Ensure that all temperature and humidity monitoring devices are recalibrated according to the equipment schedule to maintain accuracy.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
BPR: Batch Production Record

7. Documents

Batch Production Record (BPR) (Annexure-1)
Deviation Log (Annexure-2)
Temperature and Humidity Monitoring Log (Annexure-3)

8. References

USP <1163> – Pharmaceutical Dosage Forms: Capsules
FDA Guidelines for Capsule Manufacturing
International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Production Record (BPR)

Batch ID	Production Date	Temperature Range	Humidity Range	Operator Name
Batch 001	01/02/2025	25°C – 30°C	40% – 50%	John Doe

Annexure-2: Deviation Log

Deviation ID	Description	Corrective Action Taken	Operator Name
DEV-001	Humidity outside range	Adjusted humidity controls	John Doe

Annexure-3: Temperature and Humidity Monitoring Log

Time	Temperature	Humidity	Operator Name
10:00 AM	28°C	45%	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated monitoring process and equipment guidelines	Standardization	QA Head