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1. WO2020112894 - LASER INDUCED BREAKDOWN SPECTROSCOPY FOR DETERMINING CONTAMINANTS IN LYOPHILISED MEDICATIONS

Publication Number WO/2020/112894
Publication Date 04.06.2020
International Application No. PCT/US2019/063433
International Filing Date 26.11.2019
IPC
G01N 21/71 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
21Investigating or analysing materials by the use of optical means, i.e. using infra-red, visible or ultra-violet light
62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
71thermally excited
G01N 21/94 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
21Investigating or analysing materials by the use of optical means, i.e. using infra-red, visible or ultra-violet light
84Systems specially adapted for particular applications
88Investigating the presence of flaws, defects or contamination
94Investigating contamination, e.g. dust
C03B 33/00 2006.01
CCHEMISTRY; METALLURGY
03GLASS; MINERAL OR SLAG WOOL
BMANUFACTURE OR SHAPING OF GLASS, OR OF MINERAL OR SLAG WOOL; SUPPLEMENTARY PROCESSES IN THE MANUFACTURE OR SHAPING OF GLASS, OR OF MINERAL OR SLAG WOOL
33Severing cooled glass
CPC
B28D 1/02
BPERFORMING OPERATIONS; TRANSPORTING
28WORKING CEMENT, CLAY, OR STONE
DWORKING STONE OR STONE-LIKE MATERIALS
1Working stone or stone-like materials, e.g. brick, concrete ; or glass; , not provided for elsewhere; Machines, devices, tools therefor
02by sawing
G01N 21/718
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
21Investigating or analysing materials by the use of optical means, i.e. using infra-red, visible or ultra-violet light
62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
71thermally excited
718Laser microanalysis, i.e. with formation of sample plasma
G01N 21/94
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
21Investigating or analysing materials by the use of optical means, i.e. using infra-red, visible or ultra-violet light
84Systems specially adapted for particular applications
88Investigating the presence of flaws or contamination
94Investigating contamination, e.g. dust
G01N 2201/13
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
2201Features of devices classified in G01N21/00
12Circuits of general importance; Signal processing
13Standards, constitution
G01N 33/15
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
15Medicinal preparations ; ; Physical properties thereof, e.g. dissolubility
Applicants
  • GENENTECH, INC. [US]/[US] (AE, AG, AM, AO, AU, AZ, BA, BB, BF, BH, BJ, BN, BR, BW, BY, BZ, CA, CF, CG, CI, CL, CM, CO, CR, CU, DJ, DM, DO, DZ, EC, EG, GA, GD, GE, GH, GM, GN, GQ, GT, GW, HN, ID, IL, IR, JO, JP, KE, KG, KH, KM, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LY, MA, MD, ME, MG, ML, MN, MR, MW, MX, MY, MZ, NA, NE, NG, NI, NZ, OM, PA, PE, PG, PH, QA, RU, RW, SA, SC, SD, SG, SL, SN, ST, SV, SY, SZ, TD, TG, TH, TJ, TM, TN, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW)
  • F. HOFFMANN-LA ROCHE AG [CH]/[CH] (AL, AT, BE, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
Inventors
  • NORRISS, Andrew, David
Agents
  • LIMBACH, Douglas, C.
  • LIMBACH, Douglas, C.
  • SHAY, James, R.
  • ZLOGAR, Thomas, M.
  • GLENN, W., Benjamin
Priority Data
62/773,95530.11.2018US
62/835,97018.04.2019US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) LASER INDUCED BREAKDOWN SPECTROSCOPY FOR DETERMINING CONTAMINANTS IN LYOPHILISED MEDICATIONS
(FR) SPECTROSCOPIE PAR CLAQUAGE INDUIT PAR LASER POUR DÉTERMINER DES CONTAMINANTS DANS DES MÉDICAMENTS LYOPHILISÉS
Abstract
(EN)
A method of inspecting and performing material identification of a contaminant found in a vial may include identifying the presence of the contaminant in a lyophilized medicine within the vial, detaching a portion of the vial to create an enlarged opening in the vial, removing substantially an entire cake of lyophilized medicine through the enlarged opening, and analyzing the contaminant using an atomic emissions spectroscopy (AES) technique such as laser-induced breakdown spectroscopy (LIBS). Systems, fixtures and devices associated with the method are also disclosed.
(FR)
La présente invention concerne un procédé d'inspection et de réalisation d'une identification de matériau d'un contaminant trouvé dans un flacon qui peut consister à identifier la présence du contaminant dans un médicament lyophilisé à l'intérieur du flacon, à détacher une partie du flacon pour créer une ouverture agrandie dans le flacon, à enlever sensiblement un gâteau entier du médicament lyophilisé par l'ouverture agrandie, et à analyser le contaminant à l'aide d'une technique de spectroscopie d'émission atomique (AES pour Atomic Emissions Spectroscopy) telle qu'une spectroscopie par claquage induit par laser (LIBS pour Laser-Induced Breakdown Spectroscopy). La présente invention porte également sur des systèmes, sur des accessoires et sur des dispositifs associés au procédé.
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