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GMP Pharma Storage

Premium GMP Pharma Storage Solutions Across Multiple Facilities

Like so many of Alcami's Solutions, our GMP Storage Solutions began due to customer needs. Over ten years ago, our validation customers began asking if we could store their products as well as build and manage their onsite storage facilities. This request led to us planning the next phase of our business—off-site GMP storage.

We knew we had the GMP knowledge and experience with FDA regulations and was a matter of us acquiring and equipping the right facilities quickly. Today, we have four premier GMP storage facilities in the United States and are considered an industry leader in the field.

An Expansive Range of Storage Conditions

Controlled/Ambient Storage

Shelf-stable materials, medical devices, and retains can take up significant space at your in-house storage facility. Alcami's controlled temperature and ambient storage spaces have specific temperature ranges to accommodate your specifications: Real-time Aging (20°C to 25°C), Real-time Shelf Life (20°C to 30°C), and Ambient (15°C to 30°C).

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Stability Storage

When you need to store your pharmaceuticals, medical devices, APIs, or other biopharma materials, the most important objective is to ensure the materials remain in their original condition. Our stability storage chambers are flexible to meet your specific requirements while meeting ICH requirements.

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Refrigerated Storage

We store your products at optimal temperatures and tight tolerances, from 2°C to 8°C, to ensure stable environmental conditions for your critical materials.

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Freezer Storage

Our freezer storage spaces offer secure freezer storage at -20°C, -22.5°C, -30°C, -40°C, and more. Alcami provides reliable freezer storage solutions for APIs, biofluids, FBS, research samples, stability samples, and more so you can prevent any degradation or product loss.

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Ultra-Low Freezer Storage

Ultra-low freezer storage for temperature-sensitive materials is essential to maintaining the viability of biologic materials and samples. We store your drug products, substances and cells at a stable, ultra-low freezer temperature of -60°C or -75°C.

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Cryogenic Storage (LN2)

Extremely low temperatures suspend all biological activity and preserve your products for long-term storage. Alcami offers cryogenic storage solutions at vapor phase colder than -135°C with dedicated and shared space for master and working cell banks and biologic samples.

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Peace of Mind That Your Products Are Safe

Operating a life sciences company is an expensive venture; whether you are a small start-up or a large pharmaceutical or biotech company, you constantly deal with ever-increasing costs in resources, services, and space. Space is precious and can fill up quickly when storing GMP products or materials on site.

Not only is onsite storage costly, but it’s also complicated and risky. You must consider GMP protocols, regulations, and potential issues such as losing power, security, systems breaking, and developing trained staff. When you select off-site Pharma Storage, you free up precious real estate for core business needs, and you save on those unforeseen projects. When you store with Alcami, the burden shifts off you, and we provide peace of mind that your materials are safe and secure.

We treat your critical materials as if they were our own, staying compliant with SOPs, specifications, and tolerances. We know that keeping your materials secure and stable is critical to your bottom line and patient safety. You can feel confident that the materials will remain in the condition you require at any of Alcami's biostorage facilities.

Are there gaps in your storage plan?

  • Need for overflow storage space

  • Inadequate environment controls

  • On-site resource restraints

  • Product security and stability risk

  • Lack of redundancy

  • No disaster recovery plan for storage

 

Alcami fills the gaps.

  • Offsite storage space and validated cold chain transportation

  • 24/7 temperature and humidity monitoring and controls

  • Precise temperature parameters, from 70°C to -135°C

Industries We Serve

  • pharmaceutical

    Pharmaceutical

  • biotechnology

    Biotechnology

  • lifesciences

    Life Sciences

  • medicaldevice

    Medical Device

Industry-Leading Standard Operating Procedures

As a GMP pharma storage facility, we are regularly audited by our customers. Our audits reassure our clients that we follow strict procedures and that our team of experts knows how to keep your materials secure in your requested condition.

In addition to our commitment to quality in service and products, our storage customers appreciate our industry-leading processes and protocols:

If street power fails, Alcami has two high-capacity backup generators. Each is capable of running our entire biostorage operation with auto switch-over. The -75°C, -60°C, and -40°C walk-in chambers have triple-redundant cooling systems, dual compressors, and, alternatively, LN2. In addition, our GMP ambient storage warehouses have redundant heating and cooling systems. We ensure your sensitive products are protected 24/7/365 by using a combination of swipe cards, limited access, Cyber Locks on all chambers, and video surveillance monitoring with security. This extensive protection allows our customers and our Alcami staff to sleep well at night.

Our multiple monitoring systems continuously monitor and scrutinize temperature and RH conditions in our storage rooms and chambers. We also have two independent validated monitoring systems and three monitoring sensors installed in each chamber and room, based on validation mapping studies. If sensors begin to drift, alarms instigate, noting a performance change, so there is sufficient time to intervene before an out-of-tolerance situation occurs. We document all alarms, and customers are welcome to view reports.

In the rare event of an alarm, we take care of it immediately. We have a call list supported by trained technicians with backup assistance. These technicians follow written procedures to solve the problem within the chamber first, and if necessary, relocate your product to a safe environment while repairs are underway.

We also maintain and monitor conditions in the storage common areas. Like the rest of our chambers, we have performance alerts set up in those areas and on-call staff ready to address any occurrence.

Alcami also helps our customers create the best possible conditions for packaging and transportation. We care about the safety of your product long before it gets here and long after it leaves. That’s why we perform mock transportation runs with our ultra-low freezer storage and packaging equipment. We can find a solution for every customer transportation situation with our extensive inventory of traditional shippers and dataloggers as well as our own custom designed Transporter to deliver frozen products. We have a plan for all scenarios and situations, and are a proud leader in GMP storage.

At Alcami, we are committed to integrity and full transparency, which is evident when our customers audit our facility. During audits, we encourage you to review documentation, practices, and processes. You can also meet our team of storage subject matter experts and ask questions and provide feedback. These team members undergo extensive training to bring your product into our facility, maintain requested temperatures, ensure top security measures, and prepare your product to move to its next destination. We continuously review and update our processes to ensure we are employing best practices.