BR112023024278A2 - METHOD OF OPTIMIZING A FILLING RECIPE FOR A DRUG CONTAINER - Google Patents

METHOD OF OPTIMIZING A FILLING RECIPE FOR A DRUG CONTAINER

Info

Publication number
BR112023024278A2
BR112023024278A2 BR112023024278A BR112023024278A BR112023024278A2 BR 112023024278 A2 BR112023024278 A2 BR 112023024278A2 BR 112023024278 A BR112023024278 A BR 112023024278A BR 112023024278 A BR112023024278 A BR 112023024278A BR 112023024278 A2 BR112023024278 A2 BR 112023024278A2
Authority
BR
Brazil
Prior art keywords
filling
optimizing
fill weight
drug container
cpk
Prior art date
Application number
BR112023024278A
Other languages
Portuguese (pt)
Inventor
David Le
Deirdre Piedmonte
Devrishi Goswami
Jun Zhang
Raquel Santos Maria
Vikashni Padmakumar
Wei Qi
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of BR112023024278A2 publication Critical patent/BR112023024278A2/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
    • B65B3/10—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material
    • B65B3/12—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/26—Methods or devices for controlling the quantity of the material fed or filled

Abstract

método de otimizar uma receita de enchimento para um recipiente de fármacos. um método de encher um frasco. o método inclui fornecer uma bomba correspondente a um frasco e fixar um parâmetro de retração do gotejamento para a bomba em qualquer valor igual ou inferior a 20 graus. o método inclui também fixar um limite sem ajuste para um peso de enchimento do frasco em t1, em que t1 é igual a ou está em uma faixa de cerca de 2% acima ou abaixo de um peso de enchimento de um peso de enchimento alvo t0, em que um índice de desempenho do processo cpk (cpk) para o frasco ao longo de um ciclo de enchimento excede um valor mínimo.method of optimizing a filling recipe for a pharmaceutical container. a method of filling a flask. The method includes providing a pump corresponding to a bottle and setting a drip retraction parameter for the pump at any value equal to or less than 20 degrees. The method also includes setting an unadjustable limit for a vial fill weight at t1, wherein t1 is equal to or is in a range of about 2% above or below a fill weight of a target fill weight t0 , wherein a process performance index cpk (cpk) for the vial over a filling cycle exceeds a minimum value.

BR112023024278A 2021-05-21 2022-05-19 METHOD OF OPTIMIZING A FILLING RECIPE FOR A DRUG CONTAINER BR112023024278A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163191797P 2021-05-21 2021-05-21
PCT/US2022/030014 WO2022246055A1 (en) 2021-05-21 2022-05-19 Method of optimizing a filling recipe for a drug container

Publications (1)

Publication Number Publication Date
BR112023024278A2 true BR112023024278A2 (en) 2024-01-30

Family

ID=82100162

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112023024278A BR112023024278A2 (en) 2021-05-21 2022-05-19 METHOD OF OPTIMIZING A FILLING RECIPE FOR A DRUG CONTAINER

Country Status (8)

Country Link
EP (1) EP4341161A1 (en)
KR (1) KR20240011135A (en)
CN (1) CN117320964A (en)
AU (1) AU2022279223A1 (en)
BR (1) BR112023024278A2 (en)
CA (1) CA3217207A1 (en)
IL (1) IL307418A (en)
WO (1) WO2022246055A1 (en)

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Also Published As

Publication number Publication date
CA3217207A1 (en) 2022-11-24
IL307418A (en) 2023-12-01
AU2022279223A1 (en) 2023-10-19
WO2022246055A1 (en) 2022-11-24
KR20240011135A (en) 2024-01-25
CN117320964A (en) 2023-12-29
EP4341161A1 (en) 2024-03-27

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