Solid Oral Dose Process Validation, Volume Two by Ajay Pazhayattil & Naheed Sayeed-Desta & Emilija Fredro-Kumbaradzi & Marzena Ingram & Jordan Collins

Solid Oral Dose Process Validation, Volume Two by Ajay Pazhayattil & Naheed Sayeed-Desta & Emilija Fredro-Kumbaradzi & Marzena Ingram & Jordan Collins

Author:Ajay Pazhayattil & Naheed Sayeed-Desta & Emilija Fredro-Kumbaradzi & Marzena Ingram & Jordan Collins
Language: eng
Format: epub
ISBN: 9783030274849
Publisher: Springer International Publishing


Table 2.2CPPs from each of the sample unit operation include as below

Operation

CPP

Particle sizing

Milling screen size

Milling speed

Impellor type

Compaction roller speed, force

Mixing

Blending speed

Blending time

Lubrication over blend time and speed

Tableting

Compression speed

Coating

Solution spray rate

Pan speed

Product bed/exhaust temperature

CQAs collected from each unit operations as per a standard scale-up protocol are compiled as shown below (Tables 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, Figs. 2.9, 2.10, and 2.11).Table 2.3Lubrication



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