Steam-in-Place Validation

  • Use of thermal energy of condensing steam for a controlled time to clean and disinfect interior surfaces.  
  • Custom protocol consulting and development, or seamless execution of your own protocols.
  • Quickly-delivered, quality-reviewed qualification documentation for confidence and compliance.


Choose Masy for Accurate Calibration

Ensuring Compliance by Performing Steam-in-Place (SIP) Qualification

Ensuring sterility and preventing cross-contamination are critical elements of ensuring quality product production. When processing systems aren’t completely cleaned between production runs, leftover compounds, contaminant soils, and cleaning agent residue can negatively impact the safety or effectiveness your pharmaceutical drugs, biologics, or other products.

Steam-in-place (SIP) cleaning uses the thermal energy of condensing steam for a controlled time to clean and disinfect the interior surfaces of bioreactors, vessels, tanks, piping, filters, and associated fittings "in place," without costly removal of the target equipment, or time-consuming disassembly of critical production lines. High-pressure steam is repeatedly introduced into the product-contacting areas of the processing system, for sufficient duration required to reduce bioburden and neutralize contaminants. 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific 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.

With years of experience in steam-in-place validation, Masy BioServices can help ensure the sterility of your production facility and the corresponding safety and efficacy of your products. A pre-execution review of your production line design and evaluation of your test plan requirements will help us identify the critical areas and "problem spots" of your system, helping to ensure a successful validation of your steam-in-place sterilization.

With steam-in-place validation, Masy BioServices can confirm the successful application of steaming procedures, ensuring that pipe and vessel interiors are clean, sterile, and ready for your next processing cycle. We can work with you to create a custom protocol, or we will 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. We can help you develop:

  • IQ Protocols: Establishes that the circuit is properly and safely installed.
  • OQ Protocols: Verifies that the circuit consistently meets operational specifications such as alarms, controls, and operates as intended.
  • PQ Protocols: Verifies that the circuit consistently meets performance specifications under dynamic conditions.
  • RQ/CQ Protocols: Verifies that the circuit consistently meets operational specifications while the circuit is in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.

Wide Range of Calibration Capabilities

Validator 2000, Premium Thermocouples, and Wireless Dataloggers

Based on your unique needs, we can use the gold-standard Kaye Validator 2000 with premium or ultra-premium thermocouples to perform your SIP circuit qualification, or we can use DataTrace wireless dataloggers. Both options offer accuracy and reliability for your temperature mapping projects.

Fast Calibration Turnaround Time

Post-Qualification Verification of Qualification Test Equipment Confirms Accuracy

All certified validation and calibration equipment used at our customer sites are verified upon return to our NVLAP-accredited metrology laboratory. This completes the physical execution of the qualification activity that took place at your facility. No other validation company provides this level of confidence that their equipment is accurate, stable and repeatable.

Additionally, our own credentialed Quality Department will review all validation reports before delivery to ensure our final product to you meets our exacting standard. We also retain a digital copy of your completed report to assist you with future audit questions, should the need arise.


Contact Masy for Calibration

Quick Delivery of the Documentation Package

At the conclusion of your project, we will provide a clear, comprehensive validation report, confirming that your equipment is compliant to your standard operating procedures. Our validation reports contain all of the data necessary for you to have confidence in the operation of your equipment; each one is written to comply with your quality assurance practices, as well as cGMP and FDA requirements. 

Validation reports typically include:

  • Summary Report
  • Executed protocol
  • Real-time, hard copy, and soft copy of the raw data
  • Calibration certificates for all test equipment used, noting NIST traceability
  • Sensor calibration reports
  • Validation personnel detailed résumé
  • Electronic backup files for all studies

Contact Masy for Calibration

Fast Turnaround Time Keeps your Operations On-Schedule

We understand that your equipment being out-of-tolerance, or down for validation testing, can negatively impact your production schedules and capacity. We will supply enough personnel and equipment to complete the project within your specified timeframe.


Contact Masy for Calibration

Choose Masy BioServices for your Steam-in-Place Qualification Needs

When you choose Masy for your SIP qualification projects, you can enjoy the confidence that comes with knowing that your critical equipment is qualified to the highest possible standard, ensuring compliance with your SOPs and cGMP regulation – keeping your materials and products safe and effective.

Contact Masy BioServices today for your steam-in-place qualification needs.

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