GMP-Validated Cryostorage for Regulated Environments

IC Biomedical works with brands worldwide operating in industries with the strictest regulations, including biotechnology, pharmaceuticals and medical research. We ensure our products meet their highest standards, such as:

• 21 Code of Federal Regulations (CFR) Part 11: This FDA regulation ensures your electronic records meet the same essential specifications as paper records, allowing businesses to eliminate manual signing and data transfers without compromising security. Our vessels offer the tools customers need to help obtain CFR Part 11 compliance, including electronic recordkeeping capabilities and secure access protocols.
• Conformité Européenne (CE): Whether you operate internationally or ship products outside of the country, CE compliance is required to deliver products in the European Union. Our products have also been analyzed against all applicable European directives for our equipment. Note that not all of our products carry a CE mark because they do not fall under any of the EU’s New Approach Directives.
• Good manufacturing practices (GMP): All foods, beverages, pharmaceuticals and similar industries are subject to GMP or current good manufacturing practices (cGMP), a set of quality standards that keep these food- and medical-grade items safe for use or consumption. Our compliant freezer equipment enables easy sanitization and temperature control, in line with these guidelines.
• International Air Transport Association (IATA): If you ship your products by air, both the products and the containers they are shipped in must meet IATA operational standards or be IATA-exempt, like our dry vapor cryogenic shippers.

Key Specifications for Regulatory Compliant Freezers

Still, finding the right freezer and storage solutions for your needs is about more than regulatory compliance. The ideal containers will be standardized to comply with the law while offering the unique features you need for your specific applications:

• Vial capacity: Consider how many vials you have on average and how many you need to store during your busiest season.
• LN2 capacity: How often will you be able to add more liquid nitrogen to your cryogenic storage? If you’re transporting materials, what capacity is needed to maintain a stable temperature throughout the journey?
• Organization and retrieval features: How easily and quickly can you access specific samples without disrupting or compromising the rest of your product?
• Container footprint: The size of your container should be large enough to hold the amount of product you typically carry without taking up too much floor space or incurring high shipping costs.

MDR & UKCA DECLARATION OF CONFORMITY
CRYOGENIC STORAGE AND
TRANSPORTATION VESSELS

Order Compliant Cryogenic Storage at IC Biomedical

At IC Biomedical, safety, security and cryogenic equipment compliance are our top priorities. Our trusted legacy of cold chain storage and transportation technology continues to set us apart as we update our offerings to include the latest industry-best products.

Whether you are looking for high-capacity freezers, cryogenic transfer equipment, LN2 dewars or protective coverings for your team, our certified solutions are ready for shipment today.

Request a quote on any product when you contact us online. You can also learn more about our commitment to compliance by viewing or downloading our MDR and UKCA Declaration of Conformity.