Products:
Nuclear Pharm-Assist®
Nuclear Pharm-Assist® Product Trifold (pdf)
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The Nuclear Pharm-Assist® is an automated dose drawing (or dispensing) machine designed for various nuclear medicine applications. It streamlines the production and delivery of radiopharmaceuticals while controlling radiation exposure, costs, and your facilities schedule. The Nuclear Pharm-Assist® is built to suit your facilities needs based upon the radiopharmaceuticals utilized and shielding requested.
Nuclear Medicine continues to grow each year. Since 1999, PET has become a major part of Nuclear Medicine. PET radio- pharmaceuticals, as compared to traditional diagnostic SPECT radiopharmaceuticals, have an exponential increased exposure potential for the technologist, patient and pharmacist.
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| The trend indicates that PET imaging will increase, causing exposure to nuclear medicine workers to increase. Nuclear Medicine continues to grow each year. Since 1999, PET has become a major part of Nuclear Medicine. PET radiopharmaceuticals, as compared to traditional diagnostic SPECT radiopharmaceuticals, have an exponential increased exposure potential for the technologist, patient and pharmacist. The trend indicates that PET imaging will increase, causing exposure to nuclear medicine workers to increase. This increase in |

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exposure will make it more difficult for radioactive licensees to maintain traditional employee exposure limits. The Nuclear Pharm-Assist® reduces or limits exposure by embracing ALARA principles. Time and distance is limited through automation procedures, which normally would be manually performed by technologists, pharmacists and other staff, while maintaining the strictest shielding guidelines. The Nuclear Pharm-Assist® utilizes tungsten for all of its shielding during the syringe and vial filling process. Compared to lead, tungsten is nearly twice as dense and is much more user friendly and environmentally prudent.
Besides the advantage of limiting exposure, the Nuclear Pharm-Assist® offers an in-house “Unit Dose” supply, allowing a facility to program in exact filling and handling processes. The automated process eliminates potential human errors and permits your staff to change the FDG dose in real time, allowing scheduling freedom without the hassle or cost of emergency deliveries.
The Nuclear Pharm-Assist® meets or exceeds government regulations for compliance with newly adopted USP-797 guidelines, and is considered a Compounding Aseptic Containment Isolator (CACI), Class 5 environment. The addition of the Nuclear Pharm-Assist® allows you to enhance your pharmacy compounding capabilities without additional clean room construction costs, increased payroll and training. USP-797 mandated gowning and cleaning costs will be minimized as well. |
Achieving Compliance
June 1, 2008 marks the beginning of enforcement for the United States Pharmacopeia
Chapter 797 sterile compounding regulations. These regulations, which once were
informational guidelines, will now directly effect all facilities performing sterile drug
preparations. Most facilities will be underprepared, from a construction and financial stand point, to conform to these regulations. NukeMed, Inc. offers the Nuclear Pharm-Assist® as a unique solution for Nuclear Medicine facilities to achieve compliance at a cost effective price. ( www.usp.org)
Compounding Aseptic Containment Isolator (CACI)
A Compounding Aseptic Containment Isolator (CACI), as defined in the USP Guidelines, is designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size
and state of the drug being compounded. (www.usp.org)
The Nuclear Pharm-Assist® is a compounding and dispensing machine which will be
considered a Class 5 environment, gaining exemption, based on internal testing, from being placed in a Class 7 buffer area.
Cost Savings
The table below is found in the USP-797 Guidelines, stating the frequency of cleaning and disinfecting to be performed. ( www.usp.org)
| SITE |
MINIMUM FREQUENCY |
SO Class 5 (US FS 209E -
Class 100) Primary
Engineering Control (e.g.,
LAFW, BSC, CAI, CACI) |
At the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected. |
Counters and easily
cleanable work surfaces
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Daily |
Floors |
Daily |
Walls |
Monthly |
Ceilings |
Monthly |
Storage Shelving |
Monthly |
Based on the information above, a conservative cost estimate for cleaning agents, mops, wipes and gowning will be over $25,000 per year! (sites referenced: www.hepafilters.com, www.datalinksales.com, www.cleanroomconsumables.com; gowning costs based on a facility with 6 employees, $18,000.)
The Nuclear Pharm-Assist® will eliminate most of the costs incurred to achieve USP-797 compliance. When choosing the Nuclear Pharm-Assist® there is no need for major facility construction, HVAC modifications, or ante room areas. The Nuclear Pharm-Assist® will prevent spikes in personnel hours and/or the need for additional personnel, due to the increased maintenance for USP-797. Because of its ISO Class 5 certification, the Nuclear Pharm-Assist® will also cut gowning and cleaning costs by an estimated 80%!
Download PPT Presentation(pdf)
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