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- Radiopharmacy Isolators
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- Unidirectional airflow showers the work zone with a continuous supply of filtered air that sweeps contaminants out through the air exhaust system.
- Negative air pressure maintains containment of hazardous substances within the isolator.
- Easy to clean and disinfect inside and out.
- Pass-through system that isolates the interior of the unit from the room when materials are transferred in and out.
- Made of durable materials (stainless steel, glass, and high-performance, scratch-resistant plastics)
- Includes height adjustors to make the work environment ergonomic.
- Unidirectional airflow showers the work zone with a continuous supply of filtered air that sweeps contaminants out through the air exhaust system.
- Negative air pressure maintains containment of hazardous substances within the isolator.
- Easy to clean and disinfect inside and out.
- Pass-through system that isolates the interior of the unit from the room when materials are transferred in and out.
- Made of durable materials (stainless steel, glass, and high-performance, scratch-resistant plastics)
- Includes height adjustors to make the work environment ergonomic.
Radiopharmacy Isolators
Unidirectional Laminar Airflow System Maintains ISO Class 5/Class 100 air Under Dynamic Conditions. HEPA filtered unidirectional (laminar) air bathes the work area to protect the product from contamination and removes any particulates generated by sample manipulation. The unit has 1/4″ lead shielding for protection while compounding sterile radiopharmaceuticals. Users are completely shielded from materials being manipulated in the work area.
As there no true uniform industry standards for manufacturing isolators, there are significant design differences among manufacturers. A well-designed isolator that will significantly reduce microbial contamination should meet a range of minimal standards. Germfree’s Radiopharmacy Shielded Isolators meet or exceed these standards.
Compliant with proposed USP 825 and Validated to CETA CAG-002-2006 Performance Standards, Germfree’s Radiopharmacy Isolator meets or exceeds ISO 14644-1 Class 5 (Class 100) air quality under dynamic conditions. The LFGI-R Series Isolator does not require an ISO 7 Buffer Room when used as a SRPA. The unit fits Atomlab and other dose calibrators. Each Shielded Isolator undergoes rigorous physical testing to assure the unit meets performance requirements.
USP 797 Regulations for Compounded Sterile Preparations, Compounding Aseptic Containment Isolators (CACI):
USP 797 provided the first official and enforceable requirements for preparing CSPs -Compound Sterile Preparations. USP 797 is the U.S. Pharmacopeia’s (USP) Revised General Chapter for Pharmaceutical Compounding Sterile Preparations. According to the organization, these requirements set “practice standards to help ensure that compounded sterile preparations are of high quality”. The chapter also fundamentally changed the way that facilities that prepare compounded sterile preparations approach their work.
USP 797 applies to the diverse range of facilities that prepare Compounded Sterile Preparations Chapter applies to all facilities that prepare CSPs. This includes hospital and health-system pharmacies that prepare compounded sterile preparations including main hospital pharmacy operations and satellite pharmacy units. USP 797 also applies to clinics, hospital care units as well as other facilities that handle the compounding of sterile preparations. As physicians, veterinarians, and in fusion facilities change their procedures to meet USP 797 requirements, they are finding that barrier isolators can provide an ideal alternative to a more costly cleanroom.
The Food and Drug Administration states that 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.” Installing a Compounding Aseptic Containment Isolator provides cleanroom conditions within a contained workspace. Compounding Aseptic Containment Isolators provide an ISO Class 5 (Class 100) environment for product preparation, with work occurring inside a closed, pressurized work space, accessible only via a sealed gloves system.
Overall Dimensions:
LFGI-R: 36″ wide ・ 34″ deep ・ 79.5″ high
Work Area Dimensions:
LFGI-R: 32″ wide ・ 24″ deep ・ 27″ high
Designed to fit through standard door openings and elevators.
Specifications
Overall Dimensions:
LFGI-R: 36″ wide ・ 34″ deep ・ 79.5″ high
Work Area Dimensions:
LFGI-R: 32″ wide ・ 24″ deep ・ 27″ high
Designed to fit through standard door openings and elevators.
Features/Options
Radiopharmacy Isolator Features:
General Features:
Airflow
Airflow Patterns for Radiopharmacy Isolators:
CACI
Compounding Aseptic Containment Isolators: USP 797 Regulations for Compounded Sterile Preparations
USP 797 provided the first official and enforceable requirements for preparing CSPs -Compound Sterile Preparations. USP 797 is the U.S. Pharmacopeia’s (USP) Revised General Chapter for Pharmaceutical Compounding Sterile Preparations. According to the organization these requirements set “practice standards to help ensure that compounded sterile preparations are of high quality”. Chapter fundamentally changed the way that facilities that prepare compounded sterile preparations approach their work.
USP 797 applies to the diverse range of facilities that prepare Compounded Sterile Preparations
Chapter applies to all facilities that prepare CSPs. This includes hospital and health-system pharmacies that prepare compounded sterile preparations including main hospital pharmacy operations and satellite pharmacy units. USP 797 also applies to clinics, hospital care units as well as other facilities that handle the compounding of sterile preparations. As facilities change their procedures to meet USP 797 requirements, they are finding that barrier isolators can provide an ideal alternative to a more costly cleanroom.
The Food and Drug Administration states that 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.” Installing a Compounding Aseptic Containment Isolator provides cleanroom conditions within a contained workspace. Compounding Aseptic Containment Isolators provide an ISO Class 5 (Class 100) environment for product preparation, with work occurring inside a closed, pressurized work space, accessible only via a sealed gloves system.
GENERAL STANDARDS FOR USP 797 COMPOUNDING ASEPTIC CONTAINMENT ISOLATORS:
Germfree’s Compounding Aseptic Containment Isolators are an ideal solution for providing a clean work environment in the pharmacy industry when compounding sterile preparations.
As there no true uniform industry standards for manufacturing isolators, there are significant design differences among manufacturers. A well-designed isolator that will significantly reduce microbial contamination should meet a range of minimal standards. Germfree’s Radiopharmacy Shielded Isolators meet or exceed these standards:
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Germfree Laboratories Inc. creates environments that serve life science innovation and advance global health. The company, founded in 1962, designs, engineers and manufactures flexible cGMP-compliant cleanroom facilities and mobile units, as well as high containment laboratories, which are process-ready, upon deployment. www.germfree.com
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