NEW GENERATION DEHP-FREE PRODUCTS
The Biowy Freezing Bag is the first FDA-cleared DEHP-free freezing bag with Biowy’s innovative material technology, providing a safer device for blood disease treatment and cell therapy.
Why DEHP-Free?
DEHP (diethylhexyl phthalate) is the most common phthalate plasticizer in medical devices, such as intravenous tubing, IV catheters, nasogastric tubes, dialysis bags, blood bags, transfusion tubing, and air tubing. First introduced in the 1940s, DEHP makes plastics softer and more flexible.
DEHP can cause cancer, birth defects, or other reproductive harm. Exposure to DEHP may increase the risk of cancer and may also harm the male reproductive system. Exposure to DEHP during pregnancy may affect the development of the child.
DEHP can leech from medical devices into critical fluids, which is a concern for those who require extensive infusions or those who are at high risk for developing abnormalities, such as newborns in intensive care nurseries, hemophiliacs, dialysis patients, neonates, premature babies, and pregnant woman, among others.
Our test shows that current competitive products contain significantly high amounts of DEHP.
The American Academy of Pediatrics has advocated not to use medical devices that can leach DEHP into patients, and instead to use DEHP-free alternatives. In July 2002, the USFDA issued a Public Health Notification on DEHP, stating in part, "We recommend considering such [DEHP-free] alternatives when these high-risk procedures are to be performed on male neonates, pregnant women who are carrying male fetuses, and peripubertal males." The CBC documentary “The Disappearing Male” raised concerns about sexual development in male fetal development, miscarriage, and as a cause for dramatically lower sperm counts in men. If a procedure requires one of these devices and if patient is at high risk to suffer from DEHP then a DEHP-free alternative should be considered when medically safe.
Biowy FB50 Freezing Bag
Biowy FB250 Freezing Bag
Biowy FB500 Freezing Bag
Biowy FB1000 Freezing Bag
Strength Test
To provide highest quality medical device products, Biowy has evaluated the freezing bags using 10 freeze/thaw cycle tests when compared against competitive products. The results indicate that Biowy Freezing Bags are superior under similar intended uses.
10-Cycle Freeze/Thaw Test Results
WHY CHOOSE BIOWY FREEZING BAGS?
No risk of dangerous DEHP exposure.
Meet new standards requirements.
Proven to be superior to competitors’ products when tested using ten freeze/thaw cycle tests.