Heat resistant generator columns for elution systems
OwnerRobert William Riddochinventor
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Abstract
The present disclosure relates in general to nuclear medicine and generators for the production of radiopharmaceuticals for medical use. In particular, present disclosure relates to a generator column that resists high heat such as depyrogenation and sterilization. This allows some steps of the preparation of the column to be performed in a non-sterile environment. This also allows the generator column to be reusable. The present disclosure further describes methods for the preparation of a generator where a parent radioisotope is charged on the column matrix before or after the matrix is loaded in the column.
Claims20
A process of preparing a generator column for eluting a radioactive solution comprising a column filled with particulate ion exchange matrix that elutes desired radioisotope, comprising the steps of:
- a) conditioning the column at a flow rate of about 0.02 ml/hour to about 1.0 ml/hour;
- b) rinsing the column by the elution of 0.9% sodium chloride at a flow rate of 10 ml/min;
- c) sterilizing the column prior or after loading with the particulate ion exchange matrix;
- d) optionally storing the sterilized column;
- and
- e) column loading with desired radioisotope;
- wherein the column is made of a heat resistant material and is resistant to heat at a temperature of about 110° C. to about 280° C. during sterilization or depyrogenation;
- wherein the sterilized generator column loaded with radioisotope is:
- i) compliant to periodic quality assurance tests, and
- ii) the column installed therein to be sterilized prior and/or after loading to allow the column preparation of steps in a non-sterile environment.
A process of preparing a generator column for eluting a radioactive solution comprising a column filled with particulate ion exchange matrix that elutes desired radioisotope, comprising the steps of:
- a) conditioning the column at a flow rate of about 0.02 ml/hour to about 1.0 ml/hour;
- b) rinsing the column by the elution of 0.9% sodium chloride at a flow rate of 10 ml/min;
- c) sterilizing the column prior or after loading with the particulate ion exchange matrix;
- d) optionally storing the sterilized column;
- and
- e) column loading with desired radioisotope;
- wherein the column is made of a heat resistant material and is resistant to heat at a temperature of about 110° C. to about 280° C. during sterilization or depyrogenation;
- wherein the sterilized generator column loaded with radioisotope is:
- i) cleaned in a clean room;
- ii) compliant to periodic quality assurance tests selected from the group consisting of trace metal analysis by inductively coupled plasma/atomic emission spectroscopy, pyrogenic substances test by limulus amebocyte lysate (LAL) test, pH test, and radionuclide purity test using a multichannel analyzer coupled with intrinsic germanium lithium detector and computer analysis, and
- iii) the column installed therein to be sterilized prior and/or after loading to allow the column preparation of steps in a non-sterile environment.
A process of preparing a generator column for eluting a radioactive solution comprising a column filled with particulate ion exchange matrix that elutes desired radioisotope, comprising the steps of:
- a) conditioning the column at a flow rate of about 0.02 ml/hour to about 1.0 ml/hour;
- b) rinsing the column by the elution of 0.9% sodium chloride at a flow rate of 10 ml/min;
- c) sterilizing the column prior or after loading with the particulate ion exchange matrix;
- d) optionally storing the sterilized column;
- and
- e) column loading with desired radioisotope;
- wherein the column is made of a heat resistant material and is resistant to heat at a temperature of about 110° C. to about 280° C. during sterilization or depyrogenation;
- wherein the sterilized generator column loaded with radioisotope is:
- i) cleaned in a clean room;
- ii) compliant to periodic quality assurance tests, performed at least once per day prior to use and selected from the group consisting of trace metal analysis by inductively coupled plasma/atomic emission spectroscopy, pyrogenic substances test by limulus amebocyte lysate (LAL) test, pH test, and radionuclide purity test using a multichannel analyzer coupled with intrinsic germanium lithium detector and computer analysis, and
- iii) the column installed therein to be sterilized prior and/or after loading to allow the column preparation of steps in a non-sterile environment.
Dependencies are inferred from the claim text.