The Cleanroom Solution
The Biodex Germfree Portable Shielded Isolator provides the ultimate in both product and operator protection. The shielded isolator functions as a "glovebox" using negative pressure to meet NIOSH recommendations while complying with USP<797> regulations for use outside a cleanroom.
HEPA filtered unidirectional (laminar) air bathes the work area to protect the product from contamination and removes any particulate generated by sample manipulation. The operator is provided a complete shielded barrier from materials being manipulated in the work area. The Biodex Germfree Shielded Isolator meets or exceeds ISO 14644-1, ISO Class 5 (Class 100) air quality. Each shielded isolator undergoes rigorous physical testing to assure the unit meets performance requirements as validated. It is required that independent certification be performed before use.
What is a Barrier Laminar Flow Isolator?
In January 2004, USP<797> changed the way facilities that prepare compound sterile preparations (CSPs) approach their work. As the first official and enforceable requirement for CSPs, USP<797> deals with policies and practices for preparing CSPs. It applies to all facilities that prepare CSPs, including clinics, hospital care units, and main and satellite pharmacies. As facilities that prepare CSPs evaluate and change their procedures to meet USP<797> requirements, they are finding that barrier isolators provide an ideal alternative to more costly cleanrooms.
According to the Food and Drug Administration, a barrier isolator is "a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding cleanroom air and personnel."
By installing a certified barrier isolator, one can obtain cleanroom conditions within a contained workspace. Barrier isolators provide a ISO Class 5 (Class 100) environment for product preparation, with work occurring inside a closed, pressurized environment accessible only via sealed gloves that reach into the work area.
A Shielded Glovebox is not a certified barrier isolator. By choosing a certified barrier isolator, the requirement for a ISO Class 8 environment is eliminated. The Biodex Germfree Isolator is an excellent example of a well-designed shielded barrier Laminar Flow Isolator, meeting all standards and more.
To order, call 1-800-224-6339
||Shielded Isolator, 115 VAC
||Call for pricing
||Shielded Isolator, 220 VAC
||Call for pricing
||Dose Calibrator, Atomlab™ 500Plus, 100-240 VAC
Includes: Smart Display, ionization chamber, well counter, RS-232 port, vial/syringe dipper and well insert.
||GRX System – Rapid Exchange Glove System
Includes one pair of isolator sleeves, two outer rings, six inner rings and all necessary O-rings
||Total Customer Care Plan*
||Thimble Exhaust Transition Kit
For connection to external exhaust systems
Total Customer Care Plan*:
The Total Customer Care Plan is an extended warranty plan that ensures continued top performance of the Isolator after the factory warranty has expired.
- Setup, installation and up to four hours of training
- Factory certified in-service
- Extends warranty to three years parts including labor
- Isolator training DVD
- Stainless Steel Mop Handle
- Twenty Mop Heads
- Two pairs Hypalon Sleeves
*Offer applies to United States only.
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