Validation and Qualification Solutions

Protect the integrity of your critical products with precise equipment and warehouse validation

When a life sciences company stores a product or a material, it must follow cGMP guidelines to ensure the integrity and quality of the item. Whether you have a small batch of plasmids in a chamber or drums of an API (active pharmaceutical ingredient) in a freezer,  you want to make sure the storage unit is fit for purpose—qualification. You also want to make sure it will continue to operate correctly--validation. The process of qualifying and validating your storage chambers ensures your items and materials will maintain their intended condition throughout storage. 

The Masy Validation department is the gold standard in temperature mapping. We provide our customers with documented evidence that their equipment is installed correctly, operating accurately, and performing reliably.

Comprehensive IQ/OQ/PQ Validation Solutions

Controlled Temperature Unit

Refrigerators, freezers, and stability chambers provide crucial protection to your medical products and devices. Validating your controlled temperature units with Masy gives you confidence in the integrity and efficacy of the products you administer to your patients.

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Autoclave & Sterilizer

Maintain the safety and efficacy of your products by validating your autoclaves and sterilizers to the highest standards. Masy utilizes industry-leading validation practices to execute installation, operational, and performance qualifications for your sterilizer equipment.

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Steam-in-Place

Confirm the successful application of steaming procedures and ensure sterility with Masy’s steam-in-place validation practices. We help you prevent cross-contamination and deliver safe and effective products to your patients.

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cGMP Warehouse Mapping

Warehouse mapping studies are essential to maintaining cGMP and US FDA requirements. Masy performs comprehensive, efficient, and repeatable warehouse mapping studies that help you monitor the temperature of your warehouses and keep products safe.

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Photostability Chamber

Temperature and light mapping and qualification is critical to the performance and results of your photostability chambers. Masy provides a turn-key solution that includes creating, executing, and thorough documentation of photostability validation protocols.

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Ramping Chamber

Keeping your materials and products safe and in their intended condition comes from knowing your critical ramping or cycling chambers are qualified to the highest standard. Masy provides top-of-line validation and qualification services that give your life science operation confidence in your equipment’s’ performance and product efficacy.

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Industries We Serve

  • Group 48

    Pharmaceutical

  • Group 49

    Biotechnology

  • Group 47

    Life Sciences

  • Group 46

    Medical Device

Providing Intelligent Solutions in Validation and Qualification 

At Masy, we specialize in executing large-scale qualification projects – including multiple chambers, autoclaves, and warehouses. We also have the tools and expertise to execute a project of any size.  Masy has validated tens of thousands of environmental chambers and other laboratory equipment under tight timelines meeting our customers timetables and scheduling. 

The combination of our equipment, ISO processes, and expert, talented teams has made us self-sufficient and has us leading the industry. These factors set us apart from our competitors. As a result, you can count on us to handle any project with the highest quality level. We are proud to say that we are raising the bar for excellence in validation and qualification for all these reasons and more.  

 

Advantages of Working with Us:

  • We own all our equipment--a seemingly endless supply of validation equipment and access to hundreds of data acquisition systems and wireless dataloggers. Many of our competitors turn to us to rent equipment for their validation projects.
  • Fabricate, harness and label our own thermocouples. Our competition knows where to get the best products. 
  • Our equipment is calibrated and maintained by our NVLAP Accredited, ISO 17025:2017 calibration lab, ensuring the highest standards and processes (NVLAP lab code 200904-0)
  • Before reports are released to our customers, all qualification reports undergo a full in-depth quality assurance review and approval process. 
  • Masy is ISO 9001:2015 certified to ensure our commitment to quality services.

The Masy Difference

For decades, we have been proudly referred to as the experts in thermal mapping validation. Our validation team consists of specialized engineers who have undergone extensive mentorship and apprenticeship. They have been coached in real-life project management situations, striving towards subject matter expertise. Our team has executed projects throughout the country and the globe, contributing to their diverse experience.

The validation department truly excels in taking on large temperature mapping 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 6 weeks with four validation engineers. One of the best parts of this project was completing it well ahead of the customer’s schedule.

Our validation engineers explicitly report the truth and find answers while demonstrating our dedication to quality. From project start to completion, they are committed to showing that our equipment is accurate and that our services can be trusted. As a result, we are the gold standard of thermal validation and continue to raise the bar for excellence in the industry.

When you use our temperature mapping services, you partner with a transparent and trustworthy company. Integrity is at the core of who we are. Quality is not just a department – it’s ingrained in our history and future. We will continue to honor these principles, and we remain steadfastly committed to intelligent solutions in validation and qualification.

Self-sufficiency is just one way that we set ourselves apart from others. We also have industry-leading processes and experts that go above and beyond. Our talented team of nimble, covert, and specialty trained “ninjas” use regimented, efficient, and practices steps to complete validation projects. These “ninjas” know that auditors and regulatory agencies rely on our reports to ensure documented cGMP practices, which is why we are committed to reporting the truth.

Before we arrive on-site to start a validation project, we strategically plan out your project. Before releasing completed validation reports to our customer, we follow documented guidelines that outline reviewing report information and completing the approval process.

VALIDATION RESOURCES

IQ OQ PQ Validation Services Brochure

IQ/OQ/PQ Validation Services

Your trusted partner for qualification and validation excellence.

Masy BioServices performs precise qualification based on your approved standard operating procedures (SOPs). We can follow your Installation, Operational, and Performance Qualification...

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Warehouse Temperature Mapping Whitepaper

Successful Warehouse Mapping

Masy BioServices conducts dozens of warehouse temperature mappings per year. Learn about our best practices.

Pharmaceutical, biological and medical device products require controlled environmental storage conditions. Degradation can occur when the...

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Get in touch with Masy's expert validation team so we can discuss your next validation project.