Pharmaceutical Storage & Services

cGMP Pharma Storage

cGMP Pharma Storage
Materials Management
Pharma Storage & Services

cGMP Pharma Storage

Alcami’s cGMP Pharma Storage provides state-of-the-art facilities, custom condition accommodations, triple redundant power, secure chamber access, and advanced temperature and humidity monitoring technology. When you store with Alcami you can be confident that your valuable product remains stable, secure, and compliant every step of the way.

Storage Conditions

We provide offsite storage space with precise temperature parameters ranging from 70°C at the warmest to -135°C at the coldest, along with 24/7 temperature and humidity monitoring and controls.

 

Stability Storage

Stability storage chambers meet ICH condition requirements for storage of pharmaceutical drug products, medical devices, APIs, or other biopharma materials. We can match your specific condition requirements.

(40°C / 75% RH)
(30°C / 75% RH)
(30°C / 65% RH)
(25°C / 60% RH)
(25°C / 40% RH)
+ custom conditions

cGMP Controlled/Ambient Storage

Controlled temperature and ambient storage capabilities with individual temperature ranges to accommodate your specifications.

Real-Time Aging (20°C to 25°C)
Real-Time Shelf Life (20°C to 30°C)
Ambient (15°C to 30°C)
+ custom conditions

cGMP Refrigerated Storage

Refrigerated Storage Units – kept in tight tolerances to ensure stable environmental conditions for your critical materials.

(2°C to 8°C)
+ custom conditions

cGMP Freezer Storage

Freezer storage ensures proper storage of your clinical trial samples, biofluids, bulk drug substances, tissue samples, APIs, and other critical materials to prevent any degradation or product loss.

(-20°C)
(-30°C)
(-40°C)
+ custom conditions

cGMP Ultra-Low Temperature Freezer Storage

Ultra-low freezer temperature of -60°C or -75°C storage for temperature-sensitive materials, essential for maintaining the viability of biologic materials and samples.

Cryogenic Storage (Liquid Nitrogen or LN2)

Validated cGMP cryogenic storage solutions at vapor phase LN2 (-135°C) – with dedicated and shared space for preserving master and working cell banks, tissue samples and biologics.

Materials Management & Support Services

Supporting our cGMP Storage capabilities, we offer a suite of material management services, delivered by trained experts and customized to fit your project’s unique needs. We have the expertise and capabilities to support your storage requirements throughout your product development journey.

  • Aliquoting/Sampling

    Expert aliquoting/sampling services, executed by highly trained personnel in Grade C sampling booths, adhering to Annex 1 requirements.

  • Includes liquid and solid sampling for testing

  • Refrigerated Transportation

    Local and long-distance temperature-controlled or non-temperature-controlled shipments.

  • Material pick-up and delivery within a 3-hour radius of the site:

    • Validated shippers (-80°C transporters, LN2 dry shippers)
    • Temperature control / validated trucks (-20°C, 5°C, and 15°C to 30°C / Ambient)
    • 26’ trucks contain up to 12 pallets of payload capacity
    • Trucks come equipped with liftgates for ground-level service
    • Real-time monitoring available for each shipment
    • For longer-distance shipping, contact us to discuss your specific needs

  • Labeling

    Drop shipment labeling

  • Label control and reconciliation w/ QA oversight

  • Phase II – status labeling, brightstock labeling

  • Cycle Counting & Annual Inventory

    We can assist with cycle counting and annual inventory per customer need.

  • Custom Kitting

    We can assist with custom kitting of individual parts of a product or bill of material (BOM) needed for manufacturing, compiling them into a shipping container or pallet(s), and delivering to production for processing.

  • Reference Standards Management

    We can store, sample, qualify, requalify, and distribute your reference standards, all within the Alcami network.

Industry-Leading Standard Operating Procedures

As a cGMP pharma storage facility, we’re audited by our customers regularly. These audits reassure our clients that we follow strict procedures and that our team knows how to keep your materials secure in your requested condition. We continuously review and update our processes to ensure we are employing best practices.

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

Multiple Levels of Security and Redundancies

If street power fails, we have high-capacity backup generators capable of running our entire storage 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. Your products are protected 24/7/365 by using a combination of swipe cards, limited access, Cyber Locks on all chambers, and video surveillance monitoring.

24/7 Monitoring & Control

Our multiple monitoring systems continuously scrutinize the temperature and RH conditions in our storage rooms and chambers. We have an independent validated monitoring system and three monitoring sensors installed in each chamber and room. In the rare event of an alarm, we respond immediately — with a call list supported by trained technicians with backup assistance.

On-demand webinar. 5 Key Considerations when Choosing a GMP Storage Provider

Summary

Like many of Alcami’s solutions, our cGMP storage solutions began with customer needs. More than ten years ago, our validation customers started asking if we could store their products, leading the next phase of our business — off-site cGMP storage. Today, we’re a leader in the field with four premier cGMP storage facilities in the United States.

On-demand webinar. 5 Key Considerations when Choosing a GMP Storage Provider

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