CETA Compounding Isolator Questions
1. What is the testing criteria appropriate for all compounding isolators?
Answer: All compounding isolators should have testing criteria that comply with the standards set forth
by USP 797, including airflow testing, particle count, chamber pressure test...
1. What is the testing criteria appropriate for all compounding isolators?
Answer: All compounding isolators should have testing criteria that comply with the standards set forth
by USP 797, including airflow testing, particle count, chamber pressure testing, and functional testing of
alarms and interlocks.
---
2. Whose responsibility is it to determine exact testing procedures consistent with USP 797 guidelines
and assign appropriate values pertaining to that criteria?
Answer: It is the manufacturer’s responsibility to determine the exact testing procedures consistent with
USP 797 guidelines and to assign the appropriate values related to those criteria.
---
3. Where on the isolator must the criteria established in CETA CAG-002-2006 be readily visible to the
user?
Front of Cabinet
- Information that must be posted includes:
1. Date tested
2. Reference report number
3. Due for retest date
4. Tested by
5. Signature
---
4. What test is used to determine the appropriate airflow parameters are met for the manufacturer's
design intent?
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 CertifiedGrades. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $9.99. You're not tied to anything after your purchase.