Steel Table
Ideal for holding heavy L-Block shields and caves.
Ideal for holding heavy L-Block shields and caves.
Portable Shielded Isolator
Meets NIOSH recommendations while complying with USP<797> and <825> regulations for use outside a cleanroom.
Features
- Designed from the ground up for a Radiopharmacy
- Work sitting or standing with correct ergonomics
- Meets USP Radiopharmaceuticals preparation, compounding, dispensing and repackaging guidelines
- Small footprint
- Internal IV bar
- Sealed shielded dose calibrator chamber in the work surface
- Use for blood work or other compounding or drawing requirements
- Lead shielded (.25" thick) for compounding mid to low-energy sterile radiopharmaceuticals
- SO Class 5 (Class 100) Isolator
Description
The Cleanroom Solution
The 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> and <825> 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 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?
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 an 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 an ISO Class 8 environment is eliminated. The Germfree Isolator is an excellent example of a well-designed shielded barrier Laminar Flow Isolator, meeting all standards and more.
Current Good Manufacturing Practice--Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. (2020, January).
FDA.gov. https://www.fda.gov/media/88905/download
Models & Ordering
| 190-215 | Shielded Isolator, 115 VAC |
| 190-214 | Shielded Isolator, 220 VAC |
Related:
| 5130-2216 | CRC®-55tW Dose Calibrator |
| 190-220 | Thimble Exhaust Transition Kit For connection to external exhaust systems |
Replacement:
| 039-413 | Sharps Container, 3.2 qt., 30/pkg |
190-219 Total Customer Care Plan:
The Total Customer Care Plan is a package that ensures continued top performance of the Isolator.
- 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
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