Sterile Scope Testing Articles & Analysis: Older
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Stem cell therapy is a groundbreaking field in the pharmaceutical industry, offering powerful tools for treating severe diseases such as cancer. The genetic manipulations involved in this process, however, necessitate stringent regulations to ensure sterility and safety. In 2017, the Food and Drug Administration (FDA) took significant steps towards regulating stem cell therapy, marking a pivotal ...
In the pharmaceutical industry, ensuring product safety and efficacy is paramount. Therefore, rigorous testing and analysis procedures are employed to ensure that pharmaceutical products meet the required standards. CD Formulation is emerging as a trusted partner specializing in biological determinations for pharmaceutical analysis and testing. From sterility testing to disinfection efficacy ...
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced API Impurity Identification services for clients in the medical device, pharmaceutical product, and consumer product industries using a variety of techniques under standard guidance. Impurities are chemical species that differ from the chemical compositions of desired ...
BySTEMart
The U.S. Food and Drug Administration (FDA) has reported a voluntary recall of two lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use because they may contain a strain of yeast on one of more parts. The two affected lots are considered non-sterile and unsafe for use. The Mitosol Kits are an antimetabolite used by physicians in hospitals and clinics during ab ...
Health authorities reported that a tainted dye and injection used during eye surgeries caused 33 cases of rare fungal eye infections. The products were made by the same Florida pharmacy, Franck’s Compounding Lab, that produced the supplements responsible for killing 21 elite polo horses in 2009. All patients with the infections had undergone either eye surgeries or injections. According ...
The parents of Harrison Kothari, a two-year old who died from a bacterial infection caused by contaminated medical wipes, have settled a lawsuit with the Wisconsin companies that made and distributed them. The wipes, manufactured by H&P Industries, Inc. and sold by the Triad Group, were recalled in February 2011 after they were found to be contaminated by the rare bacterium Bacillus cereus. ...
Last year, it was reported that the deaths of 11 people, including a 2 year old Houston boy that died of an infection, were linked to microbial contamination issues with medical wipes. The infection, caused by a type of bacteria, resulted in the recall of tens of millions of pads and swabs. One of the companies involved with manufacturing the wipes has recently been given the Food and Drug ...
Cinnaminson, NJ, February 22nd, 2011 Earlier this month, MSNBC.com reported about the death of a 2 year old Houston boy that died of an infection that has been blamed on contaminated alcohol wipes. The infection, caused by a rare type of bacteria, is the same organism that caused a recent recall of tens of millions of pads and swabs. Since that report became public, dozens of additional people ...
EPA posted an Antimicrobial Testing Program (ATP) web page to inform the public of post-registration efficacy test results of disinfectant products on the market for use in hospitals and other public health facilities. EPA conducts post-registration testing of public health antimicrobial products to ensure that marketed products are effective against target microorganisms when used according to ...