Standard Operating Procedure for Preparation and Addition of Sugar Syrup in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/057/2025 |
| Supersedes | SOP/ELX/057/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define a standard procedure for the preparation and controlled addition of sugar syrup during the manufacturing of elixirs to ensure uniform sweetness, viscosity, and solubility in the final product.
2. Scope
This SOP applies to the preparation, filtration, and addition of sugar syrup (sucrose solution) during the production of elixir formulations in the Elixir Department.
3. Responsibilities
- Manufacturing Operator:
- Prepare sugar syrup as per batch manufacturing record (BMR).
- Filter and add the syrup to the batch using controlled procedures.
- Production Supervisor:
- Verify sugar quality, dissolution, and volume adjustment.
- Ensure proper cleaning of sugar dissolving vessel before use.
- QA Officer:
- Perform in-process checks and approve filtration and addition steps.
4. Accountability
The Production Head is accountable for ensuring that sugar syrup is prepared and added according to this SOP and that all critical parameters are documented and verified.
5. Procedure
5.1 Preparation of Sugar Syrup
- Verify the sugar type and batch number against the BMR.
- Clean and assemble the sugar dissolving tank or vessel.
- Fill the tank with purified water up to 60–70% of the required volume.
- Start agitation and slowly add the measured quantity of sugar while stirring.
- Continue stirring until the sugar dissolves completely and solution becomes clear (typically 30–45 minutes).
5.2 Filtration
- Pass the syrup through a clean 100# stainless steel screen or inline filter into a holding vessel.
- Ensure no undissolved particles or foreign matter remain.
- Check and record temperature, pH, and brix value of the filtered syrup if required.
5.3 Addition to Main Batch
- Transfer the filtered sugar syrup into the main manufacturing tank slowly with agitation ON.
- Maintain agitation at required speed (e.g., 80–100 RPM) for at least 15–20 minutes after addition.
- Record time of addition, quantity added, and operator details in the Sugar Syrup Addition Log (Annexure-1).
5.4 Cleaning After Use
- Immediately clean the sugar dissolving tank using purified water and approved detergent.
- Dry and label the tank as “CLEANED” with date and time of cleaning.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- RPM: Revolutions Per Minute
7. Documents
- Sugar Syrup Addition Log (Annexure-1)
- Sugar Syrup Filtration Record (Annexure-2)
- Sugar Tank Cleaning Log (Annexure-3)
8. References
- WHO TRS 970 Annex 4 – GMP for Liquid Oral Preparations
- ICH Q8 – Pharmaceutical Development
See also Elixir Department: SOP for Dispensing Active Pharmaceutical Ingredients for Elixirs - V 2.0
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sugar Syrup Addition Log
| Date | Batch No. | Sugar Qty (kg) | Water Qty (L) | Added By | Verified By |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-1003 | 50 | 30 | Rajesh Kumar | Sunita Reddy |
Annexure-2: Sugar Syrup Filtration Record
| Date | Batch No. | Filtration Method | Filter Type | Checked By |
|---|---|---|---|---|
| 11/04/2025 | ELX-1003 | Inline | 100# SS Mesh | Sunita Reddy |
Annexure-3: Sugar Tank Cleaning Log
| Date | Tank ID | Cleaned By | Verified By | Status |
|---|---|---|---|---|
| 11/04/2025 | SDT-05 | Ajay Mehta | Manju Sharma | Cleaned |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Issuance | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added Filtration and Cleaning Details | Process Improvement | QA Head |