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Masy Bioservices is now proudly Alcami Corporation. Explore our fully integrated services.

CTU and Storage Area Qualification Solutions

Controlled Temperature Unit (CTU) and Storage Area Qualifications to meet cGMP regulations:

Cold Rooms, Freezers, Warehouses, Incubators, Ramping Chambers, Photostability Chambers and more

We are a unique company as we not only perform qualification activities for our customers but perform qualification activities for our own cGMP facilities which are audited and inspected on a regular basis.

As a recognized leader in cGMP BioStorage, Alcami 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 that meets defined requirements. Our CTU qualification approach is comprehensive and focused on current best practices and meeting your specific needs. We are proud to be recognized as the industry gold standard in this process.

Our Approach to Storage Area and CTU Qualification

Our reputation for being quality-driven and customer-focused is supported by our flexibility toward our customers’ individual needs and procedures. We can work with you to create custom qualification protocols to suit your qualification requirements. Alcami performs precise thermal, humidity, and carbon dioxide mapping. Depending on your requirements, Alcami can perform empty and loaded distribution and thermal penetration studies should you need more in-depth knowledge of how your product maintains temperature.

Our qualification approach is designed to capture the vital elements that are applicable to the chamber type and intended use to ensure that installation (IQ), operational (OQ), and performance (PQ) criteria are all successfully met. This includes verification of your chamber’s instrument calibration, alarm function, and associated recording devices. Our experience in qualifying storage chambers/areas of all conceivable types (warehouses, stability chambers, freezers, incubators, and photostability chambers, etc.) spans over three decades.

While the qualification approach will differ in certain respects between a reach-in freezer and a warehouse, the general process we follow toward environmental qualification can be outlined in three steps:

We scope out the project with you, considering the factors for your studies including temperature range, sensor locations, quantity of sensors, collection rate and storage envelope parameters. Our team develops an understanding of your chamber design and your storage requirements to create a thorough temperature mapping plan and prepares all the essential elements to execute your studies, including the qualification protocol.

Our next step is to execute the qualification. For mapping, this includes placing all the necessary sensors and documenting their location. We determine the appropriate datalogging system to use based on the chamber type and your study requirements.

Once the mapping has ended, our validation team reviews and analyzes the data gathered from the sensors. This data is carefully reviewed and compared against the acceptance criteria to verify the CTU meets requirements. We provide you with the final report which includes a summary of test results that have been quality reviewed by Alcami.

Industry-Leading Validation Practices

For decades, Alcami has been referred to as the expert in environmental validation. We are a trusted source in thermal mapping and leverage our extensively trained validation engineers to bring your areas and equipment into compliance. Our large fleet of datalogging systems are proven and qualified and include both wired and wireless sensor types, all supported by SI traceable calibration to ensure the highest level of accuracy.

Large or small projects are no problem for our team. 

Time is valuable in a high-demand, fast-paced industry. Alcami creates time and money-saving efficiencies in the validation process by providing clear and timely communication to our clients. We notify our client immediately upon encountering any critical deviation and will also provide our data and knowledge to assist in troubleshooting. If we observe after installing our sensors that your chamber cannot pass qualification due to temperature excursions, for example, we will notify you immediately at the start of mapping rather than wait until the study is completed.

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 qualification final report, confirming your Controlled Temperature Unit meets your requirements and is fit for use.

Our team works quickly and discreetly while on and off-site of your location to minimize interruption of daily operations and complete studies efficiently. Alcami consistently meets or exceeds project and schedule requirements while never sacrificing quality or accuracy so that you can deliver your critical products to those in need on time. We pride ourselves on having well-trained staff and a large volume of calibrated equipment that allows us to execute numerous mapping studies simultaneously efficiently.

Alcami is your support provider across the entire life cycle of product development and storage

Over time, nearly all chambers will require tuning to maintain optimal performance. Customers continually return to us for their validation needs because they recognize our ability to deliver and do so in record time. In our case study, we share the example of a time when our team completed the validation of -80 freezer in just five short days, and the final invoice came in under the estimated quote. That customer now continues to call Alcami for their validation needs.

Alcami is a trusted name when your controlled chamber needs to be validated for compliance. Our cost-effective, tailored approach has allowed us to build long-term client relationships. Our customers know that when they use Alcami, they have a validation partner with expert industry knowledge that adds value for the life of the chamber and cGMP resource unlike any other.