cGMP Warehouse Mapping

Enhance Compliance and Quality of Life Sciences Products with a Stable, Validated Storage Environment

As a recognized leader in cGMP biostorage, Masy understands the complexities of storing pharmaceutical, biological and medical device products. To maintain the quality and integrity of these materials, they must be stored in a controlled environment storage chamber. These storage facilities must undergo comprehensive accuracy-checking procedures. For cGMP warehouse facilities, this process is called thermal mapping, and it’s a key element of complying with USP 1079 and cGMPs in the biotech and pharmaceutical industries. Warehouse mapping is a highly specialized process, and we are proud to be recognized as the industry gold standard in this process.

Our Approach to Warehouse Temperature Mapping

Our validation team works directly with you to review warehouse drawings and identify points of interest and concerns for thermal validation. Wireless sensors are placed throughout your warehouse within storage envelope parameters while considering “at-risk” locations and allowing for normal operation during the study. The testing is run for a minimum of seven consecutive days and takes place initially twice a year, allowing us to capture data for the most extreme outdoor low and high temperatures.

We can access your qualification study remotely, allowing us to monitor performance throughout the duration and minimizing any lost time should your facility exhibit performance issues. After the mapping is complete, you receive a comprehensive report, reviewed by our team of professionals, which details the sensor locations for subsequent testing, among many other points about our process and team.

Masy’s commitment to excellence is evident whether we’re working with a pharmaceutical market leader or with a small biotech. We partner with you to make sure your warehouse is in compliance, so your materials remain safe and effective for whoever is expecting them next--researchers, manufacturers, shippers, and ultimately patients, and anyone in between.

1. Create a Plan

We scope out the project with you, considering a number of factors for your study including temperature range, acceptable sensor locations, quantity of sensors, and storage envelope parameters. Our team gains valuable knowledge of your warehouse in order to create a thorough temperature mapping plan and prepare all the essential resources to execute your study.

2. Execute the Plan

Our next step is to place all the necessary sensors in their locations, marking each sensor with unique identifiers relative to their location, and activating the sensors. We install wireless sensors without disrupting your daily operations and are able to continue our study off-site due to the sensor’s cloud-based technology.

3. Analyze the Results

Once the mapping has ended, our validation team reviews and analyzes all of the data gathered from your warehouse sensors. We take this data and compare it to your acceptance criteria in order to verify the warehouse meets those requirements.

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WHITEPAPER

Download our whitepaper to learn more about warehouse temperature mapping.

Industry-Leading Warehouse Mapping Practices

For decades, Masy has been proudly referred to as the experts in thermal mapping validation. We are a trusted source in thermal mapping, bringing on trained validation engineers that have gone through extensive training. We use only the best equipment, including a fleet of wireless dataloggers and sensors with SI traceable calibration for temperature and humidity to ensure the highest level of accuracy.

Time is valuable in a high-demand, fast-paced industry. Masy creates time and money-saving efficiencies in the validation process by conducting pre-qualification procedures before beginning a project. Pre-qualification ensures all dataloggers and sensors being used for your thermal aping projects are calibrated to the highest NVLAP and NIST standards.

All certified validation and calibration equipment used at customer sites is verified upon return to our NVLAP accredited metrology laboratory to confirm accuracy (NVLAP lab code 200904-0). We complete your project by providing a clear, comprehensive validations report, confirming your warehouse is fit for use for your requirements. 

Our team works quickly and discreetly while on and off site of your location in order to minimize interruption of daily operations and complete studies efficiently. Masy consistently meets or exceeds project and time-frame requirements, while never sacrificing quality or accuracy, so you can deliver your critical products to those who need it most.

Masy can be your pharma support provider for any need.

We are an all-encompassing bio solutions partner, offering services for calibration, monitoring, biopharmaceutical storage, validation, and product rental & sales. Improve the efficiency of your operation and raise the bar for excellence in your products when you choose Masy as your single-source bio solutions provider.

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If you're interested in our GMP warehouse mapping, fill out the form detailing your next project and Masy's validation experts will be in touch with you soon.