Thermal Validation Experts

For over 30 years, Masy BioServices has offered Thermal Validation Services to the biopharmaceutical industry and we continue to deliver unparalleled excellence through quality services and partnerships.  Our Validation Team consists of specialized engineers who have all been subject to a mentorship-apprentice upbringing and coached into real-life project management situations with a constant strive towards subject matter expertise. We specialize in executing large-scale qualification projects including chambers, autoclaves, and warehouses.  Our Validation Engineers work directly with manufacturers to solve equipment performance issues and often give advice to our clients based on industry trends or previously encountered pitfalls.  For decades, we have been proudly referred to as the experts in the art of thermal mapping.  Masy BioServices is the gold standard of thermal validation and continues to set the bar in the industry. 

100% Self-Sufficient, One-Stop-Shop

The Validation Department at Masy BioServices is entirely self-sufficient.  When you purchase a service from us, you can rely on us to manage your validation project independently and with minimal oversight.  Our company handles all thermal service aspects of the life sciences industry including:
  • our premier Biorepository containing the largest ultra-low cold vaults on the East Coast and a world-class regiment of Stability Chambers, Freezers, and Cryogenic Storage Vessels in a controlled access area with Cyberlock Security. 
  • our Equipment Rental Department, so we operate with a seemingly limitless supply of validation equipment with access to hundreds of Data Acquisition Systems and Wireless Dataloggers. 
  • Our equipment is calibrated and maintained by our NVLAP Accredited, ISO 17025 state-of-the-art Metrology Laboratory
  • Our Predictive Monitoring Unit (PMU) along with a cutting edge Wireless Monitoring System division. 
  • Internal Shipping Department where we arc-weld adn harness thermocouples so our dedicated support system is at the tip of our fingers when we need additional equipment when working at your site. 
Masy BioServices owns, calibrates, and maintains all of the equipment used on your project.  If your site needs additional storage capabilities or a monitoring system for cGMP compliance – we can help you.  Our Validation Team uses these resources to our advantage when we plan your project.  We offer a project based fixed price and we have a vested interest in getting your project done as soon as possible so that we can move onto the next.  Due to the myriad of services we offer, we are a one-stop-shop for all your project needs.

Integrity, Trust & Transparency

When you use our Validation Service, you have partnered with a 100% transparent, trustworthy brand.  Integrity is the underlying trademark of our core service and we sincerely value our commitment to honor this principle.  Our Validation Engineers explicitly report the truth and work with you directly to find answers while demonstrating that our products and services are trusted and accurate through to project completion.

Internal Quality Assurance Department

The most powerful aspect of Masy BioServices is the support of our robust, internal Quality Assurance Department.  Our Quality Assurance Team reviews your validation reports before we ship them to you with confidence that you are receiving a product of the utmost quality with no errors.  Our company takes this very seriously and as such, any error that you discover in a report that has been reviewed by our Quality Assurance Team is classified and documented in an internal investigation followed by root cause analysis.  Any feedback given to our Validation Team will be forwarded to our Quality Assurance Department to add customer preferences into your account or we’ll consider strengthening our processes and/or procedures as a means of continuous improvement.  Our Validation Team constantly strives for perfection and we strongly value feedback.

Efficiently Planned Validation Services

Whether your project consists of a single chamber or dozens of chambers, we are well-equipped to handle any project scope.  The Validation Team has access to over 100 Data Acquisition Systems and hundreds of Wireless Dataloggers.  We are adept at performing large quantities of validation studies simultaneously by strategically planning out your project before we arrive. 

Using our dedicated fleet of test equipment, we can pre-calibrate our sensors prior to arrival at your facility so that we can move immediately into temperature mapping.  We dedicate equipment based on the outline of your project, instilling the flexibility to optimize time at your site.

The Validation Department truly excels in taking on large projects under tight deadlines by using our equipment efficiently.  We have countless examples of this including our “Gold Standard” project where we set the bar  by executing 168 chamber qualifications in a 6 week period with 4 Validation Engineers which we were successfully able to achieve well ahead of the customer’s schedule.

Our Thermal Validation Service includes:

  • Write & Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols
  • Write Detailed Summary Reports
  • Calibration Certificates for Test Equipment, NIST Traceable
  • Sensor Calibration Reports
  • Personnel Curriculum Vitae Summary
  • Electronic Backup Files
  • Thorough Quality Review of the Final Report Package

Chamber Validation

The Validation Department at Masy BioServices is persistent in emphasizing the importance of a robust Cold Chain Management strategy along with Good Chamber Practices.  We are adept in Chamber Validation and often work independently or with your facilities team to optimize equipment performance. 

From Stability applications to Cryogenic Validation, we excel in all types and sizes of chamber qualification projects involving
  • temperature mapping
  • humidity mapping
  • CO2 mapping
An environmental chamber, also known as a Controlled Temperature Unit, and includes Incubators, Stability Chambers, Refrigerators, Freezers, Cold Vaults, Ovens, and Cryogenic Storage Vessels also known as LN2 Tanks.

Our Validation Team also has significant experience with Shipper Qualifications, Controlled Rate Freezers, Ramping Chambers also known as Cycling Chambers, Robotic Ultra-Low Freezers, and Photostability Chambers including Light Mapping.

We have access to over 100 Data Acquisition Systems and hundreds of Wireless Dataloggers, so we can execute many chamber mapping studies simultaneously.  Whether your project is a single-chamber validation project or a large-scale laboratory buildout, we are well-equipped to take on any challenge and ready to meet/exceed your deadlines.

Autoclave & Sterilizer Validation

The experienced individuals on our Validation Team specialize in Sterilization applications includin:

  • Autoclaves
  • Steam-In-Place in Bioreactors and Lyophilizers
  • Vacuum Ovens
  • Depyrogenation Ovens. 
We come to your project equipped with the right tools for Sterilizers including Smart Gaskets with our own sanitary fittings and feed-through mechanisms, correct thermocouples for your application (Teflon or Kapton) and we always Choose the Right Dry Block before performing your Autoclave or Sterilizer Validation.  Our Validation Team is well-versed in the knowledge of both EN 285 and HTM 2010 guidelines and will work with your team to identify the best way to demonstrate sterility assurance.

We can also perform Steam Quality Tests using our dedicated Steam Quality Testing kits to verify Dryness, Superheat, and Non-Condensable Gas in your clean steam supply.  If you are looking for additional information to determine whether you should be performing this test, refer to Steam Quality Testing: What, Why, Where and When? - or give us a call.

Warehouse Validation

Aside from initial qualification or requalification, Warehouse Validation is usually performed on a seasonal basis; once in the Summer months and once in the Winter months.  We strategically place our wireless sensors throughout your warehouse within storage envelope parameters while taking into consideration “at-risk” locations.  Sensors are always placed in brackets or locations to allow for normal operation while the validation study is in progress.

We have the ability to access your qualification study remotely so that we can monitor performance throughout the duration of your Warehouse Mapping.  This helps minimize any lost time should your controlled warehouse exhibit performance issues during the mapping study.  Our Validation Team works directly with your team to review warehouse drawings and identify points of interest for thermal validation.  Completed reports accurately note the locations, in detail, so the sensor locations can be repeated in subsequent testing.

Other Services

Our Validation Department has great experience with Computer System Validation (Data Acquisition Systems and Electronic Monitoring Systems) and other Laboratory Equipment Validation including

  • Centrifuges
  • Shakers
  • Stirrers
  • Particle Counters
  • Powder Fillers
  • Printers
  • HVAC
  • Purified Water Systems
  • Smoke Detectors
  • Backup Generators
  • and much more

We are prepared to travel to your site anywhere in the nation. We operate from our headquarters in Pepperell, MA.  Our Mid-Atlantic Branch mirrors our scope of service and superior quality from our office in Hatfield, PA.  With the level of bandwidth and expertise our Validation Department has to offer, you can count on us to execute your projects seamlessly and ahead of schedule.


Contact us today whether your project consists of a single chamber or dozens of chambers 

Download Now!
Download the Masy Validation brochure to find out how we can help you with your next validation project.
Learn More

Thermocouple Assemblies
Our thermocouples are specifically designed for validation and thermal mapping. We offer thermocouples made from ultra-premium select grade wire; custom pre-assembled harnesses and raw wire.
Learn More

DataTrace Wireless Data Loggers
DataTrace wireless data loggers offer real-time temperature, relative humidity, and differential pressure measurement in your chamber, line, or other system.
Learn More

Validation Case Study
Validating 12 Chambers for Temperature & Humidity
Learn More

Download Now!
Download the white paper “Choosing the Correct Dry Block for High-Temperature Validation Applications".
Learn More

Related Products & Services