Steam-In-Place Validation

Preserve the Quality of Critical Products with Validated SIP Instruments

With years of experience in steam-in-place validation, Alcami is the premier provider for biotechs and pharmaceutical companies that need to verify their SIP. During the steam-in-place validation process, our expert team performs testing to confirm the successful application of steaming procedures, ensuring that pipe and vessel interiors are clean, sterile, and ready for your next processing cycle. This testing is critical because improperly functioning tools can impact the quality and safety of the sterilized products.

The Right Qualification Protocols for Your Steam-in-Place Validation Requirements

At Alcami, we are more than just a service provider, offering plug-and-play services. We are your partner, offering the highest quality of service and customizing your SIP validation experience. Alcami approaches each steam-in-place project with the ability to follow your Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols or create custom protocols. Everything we do for your organization is in accordance with US Food and Drug Administration and current good manufacturing practices (cGMP) guidelines.

Our capabilities to create custom protocols include:

IQ Protocols –Establish that the circuits are properly and safely installed.
OQ Protocols –Verifies that the circuits consistently meet operational specifications and operate as intended.
PQ Protocols –Verifies that the circuits consistently meet performance specifications under dynamic conditions.
RQ/CQ Protocols –Verifies that the circuits consistently meet operational specifications while the circuits are in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.

We can also gladly follow your Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols in accordance with US Food and Drug Administration, current good manufacturing practices (cGMP), and other cGxP guidelines.

Industry-Leading Steam-in-Place Validation Practices

At Alcami, we take a comprehensive approach to ensure this vital piece of equipment is safely installed and operating, so you can avoid any long-term fallout from improper sterilization. We evaluate your test plan requirements so that we can identify the critical areas and “problem spots” of your sterilization system.

Once we’ve successfully validated your steam-in-place sterilization, you’ll receive a comprehensive report, reviewed by a credentialed professional. For the equipment to be qualified to support sterility, it must meet specific criteria in three areas: Non- Condensable Gases, Superheat, and Dryness. Any failure to meet the requirements means the sterilizer, steam generator, or utilities need repair.

Time is valuable in a high-demand, fast-paced industry. Alcami creates time and money-saving efficiencies in the validation process by conducting pre-qualification procedures before beginning a project. Pre-qualification assesses your equipment’s performance before validation begins and determines if the equipment will likely pass or fail validation – helping you make the most informed decision before moving forward with further testing.

All certified validation and calibration equipment used at customer sites is verified upon return to our NVLAP accredited metrology laboratory to confirm accuracy (NVLAP lab code 200904-0). We complete your project by providing a clear, comprehensive validations report, confirming your equipment is fit for use for your requirements.

The success of the steam cleaning is validated by thermal mapping, where temperature sensors are placed throughout the system before steam-in-place cleaning to ensure that specified temperatures and exposure times are achieved. The temperature sensors or thermocouples are typically placed throughout the system via flanges and gaskets, eliminating the need to disassemble the system.

Reducing equipment downtime is critical to meeting the needs of patients. Alcami is fully equipped with an in-house validation team and the largest validation equipment inventory to consistently meet or exceed your project and time-frame requirements, while never sacrificing quality or accuracy.

We’re not done until your Steam-in-Place Validation is safe and effective.

Alcami can be your Comprehensive Pharma Support provider

We are a comprehensive Pharma Services partner, offering services for Metrology & Calibration, Commissioning, Qualification & Validation, Environmental Monitoring and Cleanroom Services, and GMP Pharma Storage. Improve the efficiency of your operations and quality of your products when you choose Alcami as your single-source Pharma Services partner.