Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole?

Isolators play a critical role in protecting both the product and the environment, as well as the personnel involved in pharmaceutical manufacturing, analytical procedures, and sterility testing. Gloves attached to the windows and doors of the isolator are designed to facilitate intervention, testing, and safety. However, due to their inherent characteristics and vulnerability to puncture or loss of integrity, they are recognized as a significant potential source of contamination.

Multicenter Study on Incubation Conditions for Environmental Monitoring and Aseptic Process Simulation.

Unlabelled: Environmental monitoring and aseptic process simulations represent an integral part of the microbiological quality control system of sterile pharmaceutical products manufacturing operations. However, guidance documents and manufacturers practices differ regarding recommendations for incubation time and incubation temperature, and, consequently, the environmental monitoring and aseptic process simulation incubation strategy should be supported by validation data. To avoid any bias coming from in vitro studies or from single-site manufacturing in situ studies, we performed a collaborative study at four manufacturing sites with four samples at each location.

Brush-culture method for diagnosing tinea capitis.

Using traditional methods to verify the existence of a fungal infection in children with suspected tinea capitis is a cumbersome process. Scraping scale and pulling hairs for culture or microscopic examination can be time-consuming and uncomfortable for the child. This study is the first comparison of this method with an alternate brush-culture method for diagnosing tinea capitis.

[Mesenteric fibroma].

The authors report a case of mesenteric fibroma in an 18 year old African woman revealed by an increase in the size of her abdomen without any accompanying symptoms. The complete removal of the tumor required resection of 50 cm of intestine. The postoperative course was uneventful.