Controlled rate freezers (CRFs) enable CS Analytical to replicate real-world preparation of samples requiring deep and ultracold storage, which can be incorporated into USP 1207 container closure integrity studies, ASTM and ISTA distribution testing, and custom studies incorporating -80°C or cryogenic temperature profiles.
CLIFTON, N.J., June 12, 2024 /PRNewswire-PRWeb/ -- CS Analytical Laboratory, the world's only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, has expanded it service capabilities specific to cold and ultra-cold storage and testing with the installation of Thermo-Scientific CryoMed Controlled-Rate Freezers. Critical during preparation of cryogenically stored products such as cell and gene therapy products, these freezers will enable the CS Analytical Team to replicate the freezing process in a contract laboratory environment to better meet market and client demands.
"With the marketplace focused on novel medicines such as cell and gene therapies that require storage and shipment at extremely cold temperatures, expanding our capabilities in this area is a direct response to client needs," commented Chief Scientific Officer Brandon Zurawlow. "These freezers will support a wide variety of studies, which can now be more closely tailored to the real-world experience of the products under test. Controlled rate freezing can be incorporated into USP 1207 container closure integrity studies, ASTM D4169 or ISTA distribution simulation testing, and custom studies incorporating -80°C or cryogenic temperature profiles and their impacts, such as evaluation of cryogenic label adhesion performance."
CS Analytical's CryoMed Controlled-Rate Freezers offer a temperature range of: -180°C to +50°C and a capacity of up to 48 L. Other features include dual solenoid valves that increase LN2 injection volume for precise temperature control and accelerated freezing for optimum sample viability; specially designed air handling system and liquid nitrogen ring that work in tandem for precise temperature control and uniformity, and both a chamber and sample temperature probe for multi-input profile responses. Each chamber comes with 6 preset and 10 user-defined (20 steps each) freezing profiles for custom protocols to meet a wide variety of application needs. The chamber interior allows for insertion of racks and fixtures to accommodate standard vial trays and boxes, cryogenic storage bags in cassettes, and more.
About CS Analytical Laboratory
The world's only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.
Media Contact
Brian Mulhall, CS Analytical, 1-888-571-1207, [email protected], https://csanalytical.com/
SOURCE CS Analytical
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