Operator Protection
Product Protection
Environmental Protection
Clean Air
Radiopharmacy Hood (Lead Shielded Biological Safety Cabinet)
The Esco Radiopharmacy Hood (Lead-shielded Biosafety Cabinet) offers superior protection for radioisotope laboratories. It is designed for radiopharmaceutical dispensing of generator-produced radioisotopes and dose calibration of all radioisotopes.
While radioactive substances hold various beneficial applications (e.g., power generation, medicine, industry, and agriculture), the risk of exposure of the workers, the public, and the environment to radiation hazards must be assessed and controlled. Esco Pharma provides equipment suitable to facilitate sterile and non-sterile radioactive drug handling while providing significant operator and environmental protection from potential radiation hazards
Applications:
Radiopharmaceuticals dispensing and other handling procedures
QC tests of radiopharmaceuticals
Provides product, operator, and environment protection
Protects the healthcare workers and the environment from exposure to radioactive drugs while also preventing the inside from being contaminated.
Suitable for Sterile/Aseptic Processes
Facilitates an ISO Class 5 (as per ISO 14644-1) /Grade A (EU GMP) working environment
HEPA/ULPA Filtration
Downflow and Exhaust filter (ULPA as per IEST-RP-CC001.3 and HEPA H14 per EN 1822) has a typical efficiency of >99.999% for particle size between 0.1 to 0.3 microns
Ensured Protection from Radiation
Lead-shielded sides, worktop, equipment compartments, and horizontal sliding chest shield and radiation-proof acrylic glass with Pb equivalence
Sentinel Gold Microprocessor Control System
Supervises functions, visual monitoring, and alarm system
Enhanced Operator Comfort
Ergonomic sloped front eliminates glare off the front window and ensures operator comfort during extended usage
Modular Design
Modular and easily customized with your desired equipment integrated in the work station (generator, dose calibrator, automatic dipper, waste bin)
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Customizable lead-shielded protection depending on client requirements, which may include:
- Shielded compartments for integration of generator, dose calibrator, and waste bin
- Horizontal sliding chest shield
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Option between full SS 304 construction or EG steel with white oven-baked epoxy-polyester ISOCIDETM antimicrobial powder-coated finish
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UV Lamp
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Electric Sockets
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Service Fixtures
Airflow
The radiopharmacy cabinet is typically a Class II Biological Safety Cabinet with lead lining for radiation protection. As such, the airflow configuration is similar to that of the standard Class II BSC models.
BSC Class II Type A2 Airflow Diagram
BSC Class II Type B2 Airflow Diagram
Radiation Protection
The operator is protected by applying lead shielding to the sides, worktop, equipment compartments, and horizontal sliding chest shield. The thickness of the lead shielding depends on the amount of potential radiation exposure and will vary across different types of radioactive drugs and different sections of the pharmaceutical radiopharmacy hood.
What are radiopharmaceuticals?
As defined in USP <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging, these are finished dosage forms that contain a radioactive substance in association with one or more other ingredients and that is intended to diagnose, stage a disease, monitor treatment, or provide therapy. They are also called “radioactive drugs” and can include any nonradioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance.
What are the required engineering controls for handling radiopharmaceuticals?
Based on USP <825>, sterile preparations (e.g., injectables, inhalations, and ophthalmics) must be handled in a primary engineering control (PEC) of ISO Class 5, such as laminar airflow workbenches (LAFWs) or BSCs. If used only to prepare, dispense, or repackage, the ISO Class 5 PEC may be placed in an unclassified Segregated Radiopharmaceutical Processing Area (SRPA). If used to compound sterile preparations, the PEC must be located within an ISO Class 7 or better buffer room and ISO Class 8 or better ante-room.
On the other hand, for non-sterile preparations (e.g., oral capsules and solutions), it is recommended to use chemical fume hoods, with the addition of activated charcoal filters when handling potentially volatile radionuclides.How much lead shielding must be integrated in a unit intended for Tc-99m dispensing/handling?
The lead-shielding thickness and design would always depend on the amount/dose of radiation being handled by the end-user. This value is unique per application and client. Please consult your radiation safety officer to get the correct lead-shielding design for you.
Is it possible to integrate Radioisotope Generator and Dose Calibrator to your unit? What brand/s can be accommodated by your compartments?
Yes, both sets of equipment can be integrated into the unit. The compartment design is customizable as per client's preference so it can house whichever brand/model that the client is using.
What are Esco Pharma’s other radiopharmacy equipment?
The shielded laminar flow cabinet is suited for sterile handling. Also applicable would be the Cytoculture® Lead-Shielded Biological Safety Cabinet, which has a dual exhaust filter system for added protection. For non-sterile handling, the Esco Frontier® Radioisotope Fume Hood provides operator and environment protection. For clients preferring the use of fully closed systems, the GMP-compliant Radioisotope Dispensing Isolator and Technetium Dispensing Isolator would be recommended.
