I. BACKGROUNDIn the manufacture of many pharmaceutical products (espec terjemahan - I. BACKGROUNDIn the manufacture of many pharmaceutical products (espec Bahasa Indonesia Bagaimana mengatakan

I. BACKGROUNDIn the manufacture of

I. BACKGROUND
In the manufacture of many pharmaceutical products (especially tablets and capsules),
dry particle blending is often a critical step that has a direct impact on content
uniformity. Tumbling blenders remain the most common means for mixing
granular constituents in the pharmaceutical industry. Tumbling blenders are hollow
containers attached to a rotating shaft; the vessel is partially loaded with the
materials to be mixed and rotated for some number of revolutions. The major advantages
of tumbling blenders are large capacities, low shear stresses, and ease of
cleaning. These blenders come in a wide variety of geometries and sizes, from laboratory
scale (16 qt) to full-size production models (500 ft3). A sampling of
common tumbling blender geometries include the V-blender (also called the twinshell
blender), the double cone, the in-bin blender, and the rotating cylinder.
There are currently no mathematical techniques to predict blending behavior
of granular components without prior experimental work. Therefore, blending
studies start with a small-scale, try-it-and-see approach. The first portion of this
chapter is concerned with the following typical problem: a 5-ft3-capacity tumble
blender filled to 50% of capacity and run at 15 rpm for 15 minutes produces the
desired mixture homogeneity. What conditions should be used to duplicate these
results in a 25-ft3 blender? The following questions might arise.
1. What rotation rate should be used?
2. Should filling level be the same?
3. How long should the blender be operated?
4. Are variations to the blender geometry between scales acceptable?
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I. BACKGROUNDIn the manufacture of many pharmaceutical products (especially tablets and capsules),dry particle blending is often a critical step that has a direct impact on contentuniformity. Tumbling blenders remain the most common means for mixinggranular constituents in the pharmaceutical industry. Tumbling blenders are hollowcontainers attached to a rotating shaft; the vessel is partially loaded with thematerials to be mixed and rotated for some number of revolutions. The major advantagesof tumbling blenders are large capacities, low shear stresses, and ease ofcleaning. These blenders come in a wide variety of geometries and sizes, from laboratoryscale (16 qt) to full-size production models (500 ft3). A sampling ofcommon tumbling blender geometries include the V-blender (also called the twinshellblender), the double cone, the in-bin blender, and the rotating cylinder.There are currently no mathematical techniques to predict blending behaviorof granular components without prior experimental work. Therefore, blendingstudies start with a small-scale, try-it-and-see approach. The first portion of thischapter is concerned with the following typical problem: a 5-ft3-capacity tumbleblender filled to 50% of capacity and run at 15 rpm for 15 minutes produces thedesired mixture homogeneity. What conditions should be used to duplicate theseresults in a 25-ft3 blender? The following questions might arise.1. What rotation rate should be used?2. Should filling level be the same?3. How long should the blender be operated?4. Are variations to the blender geometry between scales acceptable?
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I. LATAR BELAKANG
Dalam pembuatan banyak produk farmasi (terutama tablet dan kapsul),
blending partikel kering sering merupakan langkah penting yang memiliki dampak langsung pada konten
keseragaman. Tumbling blender tetap cara yang paling umum untuk mencampur
konstituen granular dalam industri farmasi. Tumbling blender yang berlubang
kontainer melekat pada poros berputar; kapal tersebut sebagian dimuat dengan
bahan dicampur dan diputar untuk beberapa jumlah putaran. Keuntungan utama
dari jatuh blender adalah kapasitas besar, tegangan geser yang rendah, dan kemudahan
pembersihan. Blender ini datang dalam berbagai geometri dan ukuran, dari laboratorium
skala (? 16 qt) ke model produksi ukuran penuh (? 500 ft3). Sebuah contoh dari
umum jatuh geometri blender termasuk V-blender (juga disebut twinshell
blender), kerucut ganda, blender di-bin, dan silinder berputar.
Saat ini tidak ada teknik matematika untuk memprediksi perilaku pencampuran
komponen granular tanpa terlebih dahulu karya eksperimental. Oleh karena itu, pencampuran
penelitian mulai dengan skala kecil, coba-it-dan melihat pendekatan. Bagian pertama ini
bab yang bersangkutan dengan masalah yang khas sebagai berikut: a 5-FT3 berkapasitas jatuh
blender diisi sampai 50% dari kapasitas dan dijalankan pada 15 rpm selama 15 menit menghasilkan
campuran homogenitas yang diinginkan. Kondisi apa yang harus digunakan untuk menduplikasi ini
hasil dalam blender 25-FT3? Pertanyaan-pertanyaan berikut mungkin timbul.
1. Apa tingkat rotasi harus digunakan?
2. Haruskah tingkat mengisi sama?
3. Berapa lama blender dioperasikan?
4. Variasi geometri blender antara skala diterima?
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