Our Approach
Based on your standard operating procedures (SOPs), Masy Systems performs precise thermal and humidity and/or CO2 mapping, empty chamber thermal distribution and load penetration studies with in-depth analysis. We can also calibrate your process controls and recorders traceable to NIST. We can create protocols for you or we can execute yours. As a cost-saving measure we apply our experience with instrumentation and controls, recommending and implementing essential modifications to bring your equipment into compliance.
Step 1 - Have the Right Equipment
Masy's NVLAP accredited calibration lab provides calibration certificates noting NIST traceability for all instrumentation used to execute validations at your facility.
High Performance DataTrace Validation Dataloggers
- Fast operation, enhancing your productivity
- Allows for customer product access during testing
- Supports 21 CFR Part 11 Compliance
- Unmatched accuracy of measurements with units that cover - 80°C to 140°C
- Transmits live data therefore is a non-intrusive solution to thermocouples (no feedthrough required)
- NIST Traceable to meet regulatory requirements
- User-friendly software reduces training time
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Traditional Thermocouple Validator V2000 Approach
- Utilizing Ultrapremium Type T FEP coated wires for projects ranging from -200°C to 200°C, Ultrapremium Type T Kapton coated wires for dry projects up to 350°C, and specialty thermocouples for high temperature projects as necessary.
- We utilize the correct baths to ensure the tightest accuracies necessary to meet your qualification specifications, and NIST traceability.
- Our high-end Rotronic humidity sensors are calibrated at ambient, but also calibrated specifically at the ICH point that we are qualifying to guarantee the most accurate readings.
- Masy has a variety of options for thermocouple feedthroughs and we will choose the correct one for your project which will help provide the best results.
- Masy also utilizes the best Vaisala CO2 sensors in the industry which we customized the harness to connect directly to the Validator 2000
- Masy uses a specific Rosemont pressure transducer that we can also connect directly to the V2000 and has proven excellent in meeting EN 285 autoclave specifications.
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Step 2 - Choosing the Necessary Studies
Traditional Approach - IQ / OQ / PQ
Masy Systems creates protocol procedures or follows your Installation, Operational or Performance Qualification (IQ, OQ, PQ) protocols in accordance with FDA, cGLP and cGMP guidelines.
- IQ - Establishes that the equipment is properly and safely installed
- OQ - Verifies that the chamber consistently meets operational specifications such as alarms and controls and empty chamber requirements
- PQ - Validates that the chamber consistently meets performance specifications under loaded and dynamic conditions
- RQ/CQ - Re-qualifies that the chamber consistently meets operational specifications while the chamber is in use at whatever level of capacity it is in and assists with customer’s continuous qualification efforts
- VQ - Verifies that the chamber consistently meets operational specifications on an “in-use” chamber
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ASTM E2500 Standard
Masy is well versed with the new ASTM Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. Our Validation Professionals can also support your risk based approach to qualifications, and are proficient in performing validation to these SOPs.
Step 3 - Completing the Report
Report Completion & Quality Assurance Report Review
All Validation Qualification reports undergo a full in-depth quality assurance review. We follow documented work instructions to review the final report prior to release to our customers. Masy retains a digital copy of the completed report to assist you remotely with future audit questions.
Masy creates reports which typically include:
- Executed protocol
- Real time, hard copy and soft copy mapping data
- Calibration certificates for all mapping equipment used, noting NIST traceability
- Sensor calibration reports
- Validation personnel training records
- Summary results
- Electronic backup files for all studies
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Step 4 - Closing the Project
Post Verification of Equipment
All certified validation and calibration equipment used at our customer sites is verified upon return to our NVLAP accredited calibration laboratory. This completes the physical execution of the qualifications that took place at your facility. No other validation company provides this level of confidence that their equipment is accurate, stable and repeatable.
Hire Our Validation Team, rent our equipment, buy it from us, or let us supply you with the ancillary pieces all validation teams require on a reoccuring basis.
Masy is happy to support any part of your project. If you have your own validation team, or you have another preferred vendor…Masy can still be of service. If the project is large we can supply you with a large amount of validation equipment (Dataloggers, temperature baths and standards, thermocouples, RH/CO2/Pressure standards….etc). You can also buy that same equipment from Masy. To support your team every day we supply thermocouple wire. We can send you the raw materials to make your own, or we can do all the hard work for you.
Validation
Experience - Masy has over 25 years of validation history serving the Biotech and Pharmaceutical industries.
