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Penetrable and resealable lyophilization method

  • US 8,171,652 B2
  • Filed: 06/27/2011
  • Issued: 05/08/2012
  • Est. Priority Date: 04/24/2006
  • Status: Expired due to Fees
First Claim
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1. A method of filling a device with a substance to be lyophilized, lyophilizing the substance within the device, and storing the lyophilized substance within the device, the method comprising the following steps:

  • filling a device including a body defining a chamber enclosed by a liquid-impermeable closure in sealing engagement therewith and a penetrable and resealable portion in fluid communication with the chamber, the filling step comprising;

    penetrating the penetrable and resealable portion with a tip of an injection or filling member such that a flow aperture of the injection or filling member is in fluid communication with the chamber of the device;

    introducing the substance to be lyophilized through the injection or filling member and into the chamber of the device; and

    withdrawing the injection or filling member from the penetrable and resealable portion;

    lyophilizing the substance within the chamber with the closure in engagement with the body, causing fluid to flow out of the chamber during lyophilization, and preventing at least one of contaminants and moisture from flowing into the chamber during lyophilization; and

    hermetically sealing an aperture formed by the injection or filling member in the penetrated region of the penetrable and resealable portion.

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