Standard Operating Procedure for Control of Alcohol Evaporation Loss During Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/091/2025 |
| Supersedes | SOP/ELX/091/2022 |
| 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 the procedure to minimize and control the evaporation loss of alcohol during the manufacturing of elixirs to ensure accurate alcohol content in the final product and compliance with quality standards.
2. Scope
This SOP is applicable to all elixir formulations containing alcohol (ethanol, isopropanol, etc.) as an excipient or solvent, manufactured in the Elixir Department.
3. Responsibilities
- Production Operator:
- Follow instructions to minimize alcohol exposure and document batch-related observations.
- Production Supervisor:
- Ensure all control measures are implemented and verified during manufacturing.
- QA Officer:
- Verify alcohol retention data and approve release based on final content assay.
4. Accountability
The Head of Production is accountable for ensuring implementation of all necessary controls to reduce evaporation loss and maintain product quality and safety.
5. Procedure
5.1 Material and Equipment
Controls
- Use alcohols that meet pharmacopeial specifications and store them in tightly sealed containers.
- Ensure all manufacturing tanks and containers used in alcohol-based elixir manufacturing are fitted with proper lids, seals, or nitrogen blanketing systems.
- Use closed-loop transfer systems or stainless-steel transfer lines with minimal exposure to the environment.
5.2 Manufacturing Controls
- Maintain room temperature within validated limits (not more than 25°C unless otherwise specified).
- Minimize holding time after alcohol addition by proceeding directly to the next step (e.g., mixing or sealing).
- Ensure continuous agitation during alcohol mixing to prevent stratification and to avoid prolonged surface exposure.
- Use nitrogen blanketing for storage tanks and mixing vessels wherever applicable to reduce evaporation risk.
5.3 Monitoring Alcohol Content
- Record quantity of alcohol added and final batch volume in the BMR.
- Sample the batch for alcohol assay and record the test result on the Alcohol Content Report (Annexure-1).
- Allowable alcohol loss: typically within ±5% of theoretical value unless specified by regulatory requirement.
5.4 Corrective Actions
- If alcohol loss exceeds permissible limits, investigate immediately and document in the Deviation Record.
- Adjust alcohol content if allowed by process control procedures, and document final concentration.
- If adjustment is not permissible, the batch shall be held and disposition decided by QA.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- IP: Indian Pharmacopoeia
7. Documents
- Alcohol Content Report (Annexure-1)
- Batch Manufacturing Record (BMR)
- Deviation Record (if applicable)
8. References
- IP/USP Monographs for Alcohol
- 21 CFR Part 211.105 – Equipment Identification and Control
- WHO TRS 1010 – GMP for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Alcohol Content Report
| Date | Batch No. | Alcohol Type | Theoretical Content (%) | Observed Content (%) | Deviation (%) | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1030 | Ethanol IP | 12.0% | 11.4% | -5.0% | Within limit |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added nitrogen blanketing and deviation handling | Process Optimization | QA Head |