BioClean Nitrile Isolator Gloves Greater Protection and Increased Longevity
BioClean Isolator Gloves are manufactured from nitrile with incredibly low levels of particles and excellent electrostatic discharge (ESD)properties. Designed for use in injectable manufacturing and pharmaceutical production areas, our clean or clean and sterile isolator gloves are cleanroom processed and packed and available to fit a range of port sizes.
Advanced Protection and Dexterity for Workers in Pharmaceutical Manufacturing
Gloveboxes play a vital role in protecting products from human or environmental contamination as well as protecting individuals from workplace hazards. They’re designed to provide a controlled, enclosed work environment that is separated from workers by a barrier, ensuring the containment of these sensitive and critical materials.
Every worker has the right to a safe workplace. When manufacturing specialized products in a pharmaceutical manufacturing environment, there are specific requirements for hand protection. Production and handling of these types of products typically happens in a clean or controlled environment and quite often in a sterile environment as well.
Due to the propensity of sensitive materials to be used in the life sciences, three types of gloveboxes may be used. Each is designed for the specific hazards present or level of cleanliness required.
Containment gloveboxes are designed to protect the operator and ambient environment from the material being processed. They are commonly found in pharmaceutical compounds relating to the development of oral treatments, neurological pain drugs, enhancing drugs, nuclear medicine, and other potent drugs.
Isolation gloveboxes protect the material being processed from the operator and the environment. Isolation gloveboxes are used in applications such as aseptic drug manufacturing and filling and parenteral (injectable) drug development.
Isolators combine features of containment and isolation gloveboxes and are used in the manufacture of cytotoxic parenteral drugs, some chemotherapy drugs, and biopharmaceutical cancer drugs.
Glovebox gloves provide a vital interface between the worker and the interior glovebox environment and must maintain a clean, reliable barrier while allowing the worker to effectively conduct manual tasks.1 The gloves’ integrity is crucial, as any breach in containment puts workers and products at risk of contamination.
Materials
While these gloves have traditionally been manufactured with natural rubber latex and chlorosulfonated polyethylene (CSM), recent advances in nitrile and other materials offer significantly improved protection, reliability, and longevity.
Nitrile is a synthetic, non-solvent based, FDA-compliant polymer with excellent anti-static properties that is ideal for use with solvents and powders. Nitrile can withstand temperatures of up to 248°F (120°C) and is autoclavable. It can also be sterilized by gamma irradiation and sanitized with vaporized hydrogen peroxide (VHP) and isopropyl alcohol (IPA). Nitrile gloves can also be washed, processed, and packaged within a cleanroom environment, ensuring the gloves are an ultra-low contamination risk before being introduced into the isolator glove box.
Nitrile has superior puncture resistance, dexterity, and user comfort and offers excellent chemical resistance, providing extended permeation protection against many cytotoxins and the ability to maintain its properties even after gamma irradiation.
BioClean RABS and Isolator Gloves are manufactured from nitrile with incredibly low levels of particles and excellent ESD properties, offering safety to both the worker and the products being handled. The gloves are made with accelerator-free biodegradable nitrile and individually triple bagged in easy-open low-density polyethylene (LDPE) for convenient access.
BioClean gloves are 100% inspected and water leak tested and can be gamma irradiated, providing a Sterility Assurance Level of 10-6. They meet ASTM D6978-05 standards for handling chemotherapy drugs and offer an excellent resistance to VHP and IPA.
At Ansell, we are committed to delivering cutting-edge protection, enabling workers to increase quality and productivity without putting their health at risk. BioClean Nitrile Isolator Gloves are an excellent choice for improved comfort, protection, and performance.
References
- American Glovebox Society AGS-G001-2007, http://www.gloveboxsociety.org/index.asp
