Commissioning, Qualification and Validation (CQV)

Steam-In-Place Validation

Pharma Services

Ensure Quality and Sterility with Expert Steam-In-Place (SIP) Validation

Alcami is the premier provider for biotech and pharmaceutical companies in need of steam-in-place (SIP) validation. During the critical steam-in-place validation process, our expert team performs tests to confirm the successful application of steaming procedures. This ensures that the pipe and vessel interiors are clean, sterile, and ready for your next processing cycle.

Customized Steam-In-Place (SIP) Validation to Meet Your Unique Requirements

Alcami isn’t just a service provider; we’re your partner in ensuring the highest standards of quality. We offer tailored SIP validation services, whether by following your existing Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols or developing custom protocols that align with FDA and current good manufacturing practices (cGMP) guidelines.

  • Our comprehensive SIP validation services include:

    IQ Protocols: Confirm that all circuits are correctly and safely installed.

  • OQ Protocols: Ensure that circuits consistently operate within specified parameters.

  • PQ Protocols: Validate that circuits meet performance requirements under dynamic conditions.

  • RQ/CQ Protocols: Maintain operational specifications during use, ensuring ongoing compliance.

Industry-Leading SIP Validation Practices for Optimal Sterility

Our thorough approach guarantees that your equipment is correctly installed and functioning, minimizing the risk of contamination from improper sterilization. We assess your sterilization system to identify critical areas and potential challenges, ensuring that your equipment meets essential criteria for Non-Condensable Gases, Superheat, and Dryness. Following successful validation, you’ll receive a detailed report reviewed by our credentialed professionals.

  • Pre-Qualification Services to Maximize Efficiency

  • To save you time and resources, Alcami offers pre-qualification services that assess your equipment’s performance before full validation begins. This step helps you anticipate whether your equipment will pass validation, enabling you to make informed decisions before committing to further testing.

  • Verified Results and Comprehensive Documentation

  • After your SIP validation is complete, all equipment is verified in our ISO/IEC 17025:2017-accredited metrology lab to ensure accuracy. We provide a clear and comprehensive validation report, confirming that your equipment meets all requirements for safe and effective use.

  • Thermal Mapping for Precise Validation

  • Thermal mapping is a critical component of our SIP validation process. By placing temperature sensors throughout your system, we ensure that the required temperatures and exposure times are consistently achieved. This method allows us to validate your steam-in-place cleaning without the need for system disassembly.

  • Fast Turnaround to Keep Your Operations Running Smoothly

  • At Alcami, we understand the importance of minimizing equipment downtime. Our in-house validation team and extensive inventory allow us to meet or exceed your project timelines without compromising on quality or accuracy.

  • Commitment to Safety and Efficacy in SIP Validation

  • Alcami’s extensive experience in SIP validation makes us the preferred provider for biotech and pharmaceutical companies. We are committed to ensuring that your SIP processes are both safe and effective, protecting the quality and safety of your sterilized products.

Related Topics
Commissioning, Qualification and Validation (CQV)
Autoclave & Sterilization Validation
Metrology & Calibration
Exploring FDA Findings Around Calibration
Why the FDA General Calibration Requirements are Not Enough
Contact Alcami
Summary

Alcami provides expert Steam-In-Place (SIP) validation services to ensure biotech and pharmaceutical equipment is clean, sterile, and compliant with regulatory standards. We offer customized validation protocols and pre-qualification services to optimize efficiency and minimize downtime. With thorough testing, thermal mapping, and detailed documentation, Alcami guarantees the safety and effectiveness of your sterilization processes.

Related Topics
Commissioning, Qualification and Validation (CQV)
Autoclave & Sterilization Validation
Metrology & Calibration
Exploring FDA Findings Around Calibration
Why the FDA General Calibration Requirements are Not Enough
Contact Alcami
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