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BTC 195 Exam Questions & Answers 2024/2025
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BTC 195 Exam Questions & Answers 2024/2025
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BTC 195 Exam Questions & Answers2024/2025
Name and describe 4 layers of a bioreactor and function - ANSWERS1. Interior wall: made up of stainless
steel and provides a sterile contact surface for the product
2. Jacket: heat transfer surface that is welded to the outside of the interior wall. Temperature control
module linked to an automated control system
3. Insulation: between jacket and outer sheathing, reduces heat loss
4. Outer sheathing: the visable outer layer of the bioreactor, encloses insulation and glycol jackey
Six-system Inspection Model (QFMPPL) - ANSWERSQuality system, facilities/equipment style, materials,
production, packaging and labeling, lab controls
3 common research mistakes+consequences - ANSWERS1. Production processes not well controlled:
inconsistent production
2. Several identical batches have not been produced or throughly evaluated: failure to yield consistent
product quality and stability
3. Product process not clearly established: scale up process difficulties, product strength/identity
compromised
Describe cGMP - ANSWERS-costs more $$ and more innovative tech
-application: direct manufacturing processes
Usage: less countries than GMP
QA: more reliable than GMP
Acquisition: requirements less acquirable than GMP
Describe GMP - ANSWERSCosts less
Broader application than GMP
More than 100 countries use GMP
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