Exam (elaborations)
BTC 195 Exam Questions & Answers 2024/2025
- Course
- Institution
BTC 195 Exam Questions & Answers 2024/2025
[Show more]
Content preview
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Bensuda. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $7.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
76747 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now