Depyrogenation Oven Qualification

Sterilization of Glassware and Heat Resistant Metal Appliances

  • Temperature mapping of your depyrogenation ovens for IQ/OQ/PQ.
  • 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 your Depyrogenation Oven Qualification

Depyrogenation ovens are used for the sterilization of glassware and heat-resistant metal appliances. Because pyrogens are resistant to changes in acidity and are thermally stable, extended exposure to high temperatures (generally ≥250˚C) is required for their inactivation. Adequate heating for a period of time will result in the logarithmic reduction of endotoxin levels.

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Masy BioServices offers the equipment and experienced validation personnel to assist you from unit installation qualification through to performance and continuing qualification studies. 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 oven is properly and safely installed.
  • OQ Protocols: Verifies that the oven consistently meets operational specifications such as alarms, controls, and operates as intended.
  • PQ Protocols: Verifies that the oven consistently meets performance specifications under dynamic conditions.
  • RQ/CQ Protocols: Verifies that the oven consistently meets operational specifications while the oven is in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.

Pre-Qualification Services Improve Efficiency and Cost-Effectiveness

As a cost-saving measure, we apply our experience with instrumentation and controls, recommending and implementing essential modifications to bring your oven into compliance. Over time, nearly all ovens will require tuning to maintain optimal performance. Masy BioServices can assess your oven’s performance before qualification begins, and if possible, tune the oven to reach optimal performance. Through a pre-qualification evaluation, we can determine if the oven will likely pass or fail validation – helping you make the best decisions before you spend time and money on oven qualification. 


Wide Range of Calibration Capabilities

Unparalleled Experience in Depyrogenation Oven Qualification

Similarly to autoclaves, depyrogenation ovens require cycle development and empty chamber mapping to determine hardest-to-heat locations within the chamber. Performance qualification of a depyrogenation oven generally includes load temperature mapping and endotoxin studies with inoculated samples or biological indicators. 


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 oven validation, 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 Depyrogenation Oven Qualification Needs

When you choose Masy for your oven 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 depyrogenation oven qualification needs

 

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