Lab-Grade Cell Freezing Cryogenic Tubes – GMP & ISO Certified

From Raw Material to Finished Product: Our GMP-Compliant Manufacturing Process

Great products start with great processes. At our dust-free GMP compliant workshop, every step of production is controlled, monitored, and documented to ensure the highest quality standards. Here's a behind-the-scenes look at how we make our cryogenic tubes:

Step 1: Sourcing Medical Grade Materials

We start by selecting only the highest quality raw materials. Our polypropylene resin is sourced from trusted suppliers who provide full traceability documentation, including certificates of analysis (CoA) for every batch. Before production, each resin lot undergoes testing for purity, melt flow rate, and cold resistance to ensure it meets our strict specifications. No exceptions.

Step 2: Precision Injection Molding

Next, the resin is fed into our state-of-the-art injection molding machines. Using custom-designed molds (engineered in-house by our team of), we shape the tube bodies and caps with micron-level precision. Our machines are equipped with real-time monitoring systems that track temperature, pressure, and cycle time, ensuring consistency across every tube. After molding, each component is inspected for defects like warping, flash, or incomplete filling—any part that doesn't meet our standards is immediately rejected.

Step 3: Assembly and Sealing

Once the tube bodies and caps are molded, they move to our cleanroom assembly line. Here, operators (wearing full sterile gowns, gloves, and masks) manually inspect each part before assembling the tubes. The silicone gaskets are inserted into the caps with precision tools to ensure a perfect fit, and the caps are screwed onto the tubes to test threading and seal integrity. This hands-on approach might seem old-fashioned, but it allows us to catch issues that automated systems might miss—like a gasket that's slightly misaligned or a cap with a hairline crack.

Step 4: Sterilization and Packaging

Sterility is non-negotiable for lab use. That's why all our cryogenic tubes undergo gamma irradiation sterilization, a process that eliminates 99.9999% of microorganisms (achieving a Sterility Assurance Level, or SAL, of 10⁻⁶). After sterilization, the tubes are packaged in peel-open, sterile barrier bags to maintain sterility until use. For bulk orders, we offer trays that fit standard cryogenic storage racks, making organization in liquid nitrogen tanks a breeze.

Step 5: Quality Control (Because We Test Everything)

Before any batch leaves our facility, it undergoes a battery of tests. We check for leaks by submerging tubes in colored solution and applying pressure. We test cold resistance by subjecting tubes to 100 freeze-thaw cycles (from -196°C to 37°C) and inspecting for cracks. We verify sterility by incubating samples in growth media and checking for microbial growth. And we measure dimensions, graduation accuracy, and label adhesion to ensure consistency. Only when a batch passes all these tests do we release it to customers.