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System for dispensing a fluid in non-controlled environments

A fluid and environmental technology, applied in applications, liquid materials, lightweight protective containers, etc., can solve problems such as non-compliance with GMP, destroying distribution principles, and application limitations of distribution systems

Inactive Publication Date: 2011-03-02
GE HEALTHCARE LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the application of this dispensing system in other radiopharmaceutical production laboratories has been limited because the dispensing kits have been designed to function with specific hardware designs incorporated within GMP shielded enclosures
Associated hardware will be difficult to retrofit into existing shielded enclosures
Additionally, other radiopharmaceutical manufacturing facilities may not be GMP compliant, which can undermine distribution principles, and therefore fail to obtain MHRA approval

Method used

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  • System for dispensing a fluid in non-controlled environments
  • System for dispensing a fluid in non-controlled environments
  • System for dispensing a fluid in non-controlled environments

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Embodiment Construction

[0024] The present invention is a method for providing aseptic dispensing of drugs in a non-sterile dispensing system. Alternatively, the present invention makes a GMP compliant dispensing system suitable for use in an uncontrolled, non-sterile or non-GMP compliant environment. GMP is an abbreviation for Good Manufacturing Practices (those standards required by the pharmaceutical industry for the sterile or controlled production of pharmaceutical products). Further alternatively, the present invention can be adapted to dispense any fluid that must be dispensed in a "clean" environment. In one embodiment, the present invention provides a kit for attaching to an existing dispenser. The kit includes the dispensing hardware required to direct the dispensed fluid from the collection bottle to each product bottle. Alternatively, the present invention provides the entire dispensing hardware as a complete pre-assembled sterile kit. The kit includes a supply fluid path starting from ...

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PUM

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Abstract

The present invention provides a dispenser cassette (110) which provides at least one product dispense vial (122) to be filled. The cassette provides a filtrate conduit (128) extending between the dispense vial and a filter unit (116) so that flowpath (120) of the filtrate conduit and the dispense vial is provided and maintained as an environmentally-controlled, or GMP-compliant, volume. The resulting product dispensed into the dispense vial is thus dispensed in a GMP-compliant environment.

Description

Technical field [0001] The invention relates to on-site radiopharmaceutical preparation. More specifically, the present invention relates to a device and method for Good Manufacturing Practice (GMP) distribution in an uncontrolled environment. Background technique [0002] The distribution principle of the sterile kit and associated hardware has been reviewed by the UK Regulatory Authority (MHRA) and approved for use. This enables the delivery of injectable radiopharmaceuticals directly from the shielding enclosure when using sterile dispensing technology. Figure 1 depicts a schematic diagram of a prior art distribution system 10 operating within the scope of a laminar flow cabinet ensuring that all connections can be made in a controlled (desirably GMP compliant) environment. The distribution system 10 receives the supply fluid into the large-capacity collection bottle 12 through the "product inlet". The supply fluid is typically provided directly by a separate manufacturing ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B65B3/00B65B3/12B65B55/02
CPCB65B3/12B65B55/02B65B3/003G21F5/015Y10T24/44017
Inventor C·斯蒂尔R·佩蒂特P·克罗斯比S-E·林加德
Owner GE HEALTHCARE LTD