Standard Operating Procedure for Packaging of Capsules with Desiccants
| Department | Capsule Packaging |
|---|---|
| SOP No. | SOP/CP/205/2025 |
| Supersedes | SOP/CP/205/2022 |
| 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 describe the procedure for packaging capsules with desiccants to ensure that moisture-sensitive capsules are protected during storage and distribution.
2. Scope
This SOP applies to the packaging process of all moisture-sensitive capsules, specifically when desiccants are used. It includes steps for inserting desiccants into packaging materials, ensuring capsule protection, and confirming packaging integrity.
3. Responsibilities
- Packaging Operator: Responsible for inserting desiccants into packaging materials and ensuring correct placement of desiccants in the bottles or blister packs.
- Quality Control (QC): Responsible for inspecting packaged capsules to verify the correct amount and placement of desiccants, as well as ensuring the overall packaging meets specifications.
- Production Supervisor: Ensures that packaging operations are carried out as per the SOP, monitors the quality of packaging, and handles any deviations.
4. Accountability
The Production Manager is responsible for ensuring proper packaging procedures are followed, including the inclusion of desiccants. The QC Manager ensures the quality of the packaging and product.
5. Procedure
5.1 Pre-Packaging Preparation
Before starting the packaging process, ensure the following:
-
Prepare Packaging Materials
- Ensure that the necessary packaging materials (bottles, blister packs, caps, and desiccants) are available, intact, and meet the required standards.
- Ensure that the desiccants are sealed and labeled correctly to prevent exposure to moisture before use.
-
Verify Capsule Batch
- Ensure that the correct batch of capsules is ready for packaging, confirming the batch number, quantity, and product details as per the batch production record (BPR).
-
Check Packaging Machine Settings
- Ensure that the packaging machine is calibrated for the correct bottle size and fill volume. Set up the machine to accommodate the inclusion of desiccants in the packaging process.
5.2 Packaging Process
Follow these steps during the packaging procedure:
-
Load Capsules into Packaging Line
- Ensure capsules are properly loaded into the packaging machine for bottling or blister packing.
-
Insert Desiccants
- For bottle packaging, ensure that each bottle is fitted with the correct number of desiccants as specified by the product requirements. For blister packs, place desiccants in the appropriate cavity or packet before sealing the blister pack.
- Ensure desiccants are inserted carefully to prevent damage to the capsules.
-
Seal the Packaging
- Seal the bottles or blister packs according to the specified procedure to ensure that the desiccants are enclosed and the packaging is airtight.
-
Ensure Proper Labeling
- Ensure that the packaging is correctly labeled with the product name, batch number, manufacturing date, and expiry date. The label should also mention the presence of desiccants if required by regulatory standards.
5.3 Post-Packaging Activities
After completing the packaging process, ensure the following:
-
Inspect Packaged Products
- Perform a visual inspection of the packaged products to ensure that all capsules are properly packed with desiccants, and the seals are intact.
-
Monitor Desiccant Placement
- Ensure that the desiccants are placed in the correct position and have not been displaced or damaged during the packaging process.
-
Store Packaged Capsules
- Store the packaged capsules in a suitable storage area, ensuring they are protected from moisture, light, and temperature variations.
-
Record Packaging Data
- Document the packaging process, including the number of bottles or blister packs produced, the number of desiccants used, and any defects or deviations encountered during packaging.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- BPR: Batch Production Record
- USP: United States Pharmacopeia
7. Documents
- Annexure 1: Packaging Log
- Annexure 2: QC Inspection Report
- Annexure 3: Desiccant Calibration Log
8. References
- USP <701> – Disintegration of Tablets and Capsules
- European Pharmacopoeia 2.9.1 – Dissolution Testing
- Good Manufacturing Practice (GMP) Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure 1: Packaging Log
| Batch ID | Packaging Date | Number of Bottles | Desiccants Used | Operator | Comments |
|---|---|---|---|---|---|
| Batch 017 | 04/02/2025 | 40,000 | 40,000 sachets | John Doe | No defects |
Annexure 2: QC Inspection Report
| Batch ID | Inspection Date | Defects Identified | Corrective Actions | Final Outcome |
|---|---|---|---|---|
| Batch 017 | 04/02/2025 | None | None | Approved |
Annexure 3: Desiccant Calibration Log
| Desiccant Type | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Silica Gel | 01/02/2025 | Jane Smith | Calibration of desiccant moisture absorption capacity | 01/02/2026 |
12. Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial version of SOP | Creation of SOP for packaging with desiccants | QA Head |
| 01/02/2025 | 2.0 | Updated desiccant calibration and packaging process | Improved moisture protection for capsules | QA Head |