Sterilizable pharmaceutical package for ophthalmic formulations
US-2020171244-A1 · Jun 4, 2020 · US
US11759100B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-11759100-B2 |
| Application number | US-202016830329-A |
| Country | US |
| Kind code | B2 |
| Filing date | Mar 26, 2020 |
| Priority date | Mar 29, 2019 |
| Publication date | Sep 19, 2023 |
| Grant date | Sep 19, 2023 |
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A method for cleaning a medical instrument and for detecting residue thereon is provided in which method a non-sterile or conventionally sterilized medical instrument is exposed to pressure below 100 hPa, and, subsequently, exposed to at least one gas reactive to the residue.
Opening claim text (preview).
The invention claimed is: 1. A method for cleaning a medical instrument and for detecting residue thereon, comprising: (a) obtaining a non-sterile or conventionally sterilized medical instrument; (b) loading said medical instrument into a deposition and/or analysis apparatus; (c) exposing said medical instrument to pressure below 100 hPa, (d) exposing said medical instrument to at least one gas reactive to the residue, wherein, during at least steps at (c) and/or (d), the residue is detected and/or quantified, by at least one sensor device, in at least a part of a gas flow evacuated from the deposition and/or analysis apparatus during steps (c) and (d) in an uninterrupted manner, wherein, in a condition that concentration of the residue detected and/or quantified at (c) and/or (d) exceeds a predetermined threshold, the medical instrument is reverted to a procedure of cleaning and/or sterilization by conventional methods, and wherein, in a condition that concentration of the residue detected and/or quantified at (d) pertains to a predetermined level, the medical instrument is subjected to disposal. 2. The method of claim 1 , wherein the medical instrument thus obtained is pre-applied, at least partly, with a chemically deposited coating. 3. The method of claim 1 , wherein a coating is pre-applied onto at least a part of said medical instrument by Atomic Layer Deposition (ALD). 4. The method of claim 1 , wherein the medical instrument is exposed, at (c) to a pressure below 10 hPa. 5. The method of claim 1 , wherein, at (d), said at least one gas contains a chemical substance reactive to the residue. 6. The method of claim 1 , wherein the medical instrument is a multi-part medical instrument. 7. The method of claim 1 , wherein, during at least steps at (c) and/or (d), the at least one sensor device is configured to detect and/or quantify an amount of at least one gaseous compound reactive to the residue and/or of the products of chemical reactions between the at least one gaseous compound and the residue, respectively. 8. The method of claim 1 , wherein steps (c) and (d) are performed sequentially or simultaneously. 9. The method of claim 1 , wherein the medical instrument is exposed, at (c) to a pressure below 1 hPa. 10. The method of claim 1 , wherein the medical instrument is exposed, at (c) to a pressure below 0.1 hPa. 11. The method of claim 1 , wherein the medical instrument is an endoscope device.
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provided with means for cleaning post-use · CPC title
provided with means for cleaning in-use · CPC title
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