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Pharma Services

CTU & Storage Area Qualification

Pharma Services

CTU & Storage Area Qualifications to Meet GMP Regulations

At Alcami, we not only perform qualification activities for our customers, but we also perform qualification activities for our own GMP facilities — which are audited and inspected on a regular basis. This makes us unique.

As a recognized leader in GMP Storage, we understand 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 Controlled Temperature Unit (CTU) qualification approach is comprehensive, focused on current best practices and meeting your specific needs.

Working with Alcami, you’re assured you’re in compliance with GMP regulations, have high-quality storage environments for your pharmaceutical, biological, or medical device products, and enjoy the peace of mind of knowing your materials are stored in controlled environments meeting the defined requirements.

Our Approach to Storage Area & CTU Qualification

Our reputation for being quality-driven and customer-focused is supported by our flexibility when it comes to our customers’ individual needs and procedures. We can work with you to create custom qualification protocols to suit your unique 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.

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:

Create a Plan
We scope out the project with you, considering factors for your studies such as temperature range, sensor locations, quantity of sensors, collection rate and storage envelope parameters. Our team develops an understanding of your chamber design and storage requirements to create a thorough temperature mapping plan and prepares all the essential elements to execute your studies, including the qualification protocol.
Execute the Plan
The 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, based on the chamber type and your study requirements.
Analyze the Results
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 quality-reviewed by Alcami.

Industry-Leading Validation Practices

For decades, Alcami has been referred to as an expert in environmental validation. We’re a trusted source in thermal mapping, leveraging our extensively trained validation engineers to bring your areas and equipment into compliance. Our large fleet of datalogging systems is proven and qualified — and includes both wired and wireless sensor types, all supported by SI traceable calibration to ensure the highest level of accuracy, for projects of any size.

Communication & Technical Support
Time is valuable. By providing clear, timely communication to our clients, Alcami creates time and money-saving efficiencies throughout the validation process. We’ll notify you immediately upon encountering any critical deviation, and we’ll provide our data and knowledge to assist in troubleshooting. After installing our sensors, if we observe that your chamber cannot pass qualification due to temperature excursions, for example, we’ll notify you immediately at the start of mapping rather than wait until the study is completed.
Post-Qualification Verification & Documentation Delivery
All certified validation and calibration equipment used at customer sites is verified upon its return to our ANAB-accredited calibration laboratory — to confirm accuracy. We complete your project by providing a clear, comprehensive qualification final report, confirming your CTU meets your requirements and is fit for use.
Fast Turnaround Time to Keep Operations On-Schedule
The Alcami team works quickly and discreetly to minimize interruption of your daily operations and to complete studies efficiently – whether we’re working on or off-site. We consistently meet or exceed project and schedule requirements, never sacrificing quality or accuracy, so you can deliver your critical products on time. Our well-trained staff and large volume of calibrated equipment allows us to execute numerous mapping studies simultaneously efficiently.
Long-Term Support for Chamber Qualification
Over time, almost 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 high quality work on an efficient time line.

Our cost-effective, tailored approach has allowed us to build long-term client relationships. Our customers know that with Alcami, they have a validation partner with expert industry knowledge that adds value for the life of the chamber and GMP resources.

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