Standard Operating Procedure for SIP (Steam in Place) Process in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/134/2025 |
| Supersedes | SOP/ELX/134/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To describe the standard procedure for performing Steam In Place (SIP) for sterilization of internal surfaces of manufacturing equipment, transfer lines, and tanks in the Elixir Department to ensure microbial control prior to use.
2. Scope
This SOP applies to all equipment and pipelines in the Elixir Department that require in-situ steam sterilization, including reactors, holding tanks, and transfer lines, especially those used for alcohol-based and sterile elixir preparations.
3. Responsibilities
- Production Operator:
- Execute SIP cycle as per validated protocol.
- Ensure line connections and safety checks before initiation.
- Engineering Department:
- Maintain steam lines, SIP valves, and temperature sensors.
- Verify steam quality and pressure settings.
- QA Officer:
- Review SIP logs and verify temperature-time compliance.
4. Accountability
The Production Head is accountable for execution of SIP operations. The Engineering Head is responsible for maintenance and validation of SIP systems.
5. Procedure
5.1 Pre-SIP Preparation
- Ensure the equipment to be sterilized is labeled “CLEANED.”
- Check for availability of pure steam, drain traps, and filters.
- Verify the system is properly drained of cleaning liquids and completely sealed.
- Install biological/chemical indicators if required as per validation protocol.
5.2 SIP Parameters
- Use pure steam at 121°C ±2°C for not less than 30 minutes or as per validated time-temperature profile.
- Ensure the equipment temperature reaches and maintains required sterilization conditions uniformly across all critical points.
5.3 SIP Execution
- Start the SIP program through the control panel or manual valves.
- Gradually open the steam inlet valve to prevent thermal shock.
- Monitor:
- Inlet and outlet temperatures
- Steam pressure (typically 1.1–1.3 bar)
- Condensate removal rate
- Log temperatures at the beginning, every 5 minutes during the hold period, and at the end of the cycle.
5.4 Post-SIP Steps
- Close steam inlet and allow the system to depressurize gradually.
- Ensure equipment cools down to ambient temperature before further use or sampling.
- Collect and analyze indicators (if applicable).
- Affix “STERILIZED” label with SIP date, expiry date/time, and authorized signatory.
5.5 Safety and Precautions
- Never open equipment or valves under pressure.
- Ensure condensate lines are not blocked.
- Wear gloves, heat-resistant apron, and face shield during SIP operations.
- Use proper lock-out/tag-out procedures during maintenance.
6. Abbreviations
- SOP: Standard Operating Procedure
- SIP: Steam In Place
- QA: Quality Assurance
- CIP: Clean In Place
7. Documents
- SIP Log (Annexure-1)
- Biological/chemical indicator report (if used)
- Steam Quality Certificate
8. References
- 21 CFR Part 211.113 – Control of Microbial Contamination
- WHO TRS 1010 – Sterile Manufacturing Guidance
- ISO 17665 – Steam Sterilization 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: SIP Log
| Date | Equipment ID | Start Time | End Time | Max Temp (°C) | Hold Time (min) | Operator | QA Verification |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | RT-104 | 08:10 | 09:00 | 121.5 | 30 | Rajesh Kumar | Sunita Reddy |
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 biological indicator steps and temperature control details | Validation Update | QA Head |