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BTC 195 Exam Questions & Answers 2024/2025 $7.99   Add to cart

Exam (elaborations)

BTC 195 Exam Questions & Answers 2024/2025

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BTC 195 Exam Questions & Answers 2024/2025

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  • August 9, 2024
  • 3
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • BTC 195
  • BTC 195
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Bensuda
BTC 195 Exam Questions & Answers
2024/2025

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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