U.S. Department of Health and Human Services ANSWER Guidance for Industry - Sterile
Drug Products Produced by Aseptic Processing : Current Good Manufacturing Process
A. National Institute of Occupational Safety and Health
B. Hazardous Drugs List - ANSWER A. Acronym: NIOSH
Calibration Procedures and Guidelines for Select Equipment Used in Testing
Cleanrooms and Other Controlled Environments - ANSWER IEST-RP-CC013.2
,HEPA and ULPA Filter Leak Tests - ANSWER IEST-RP-CC034.3
Cleanrooms and associated controlled environments - Classification of air cleanliness
by particle concentration - ANSWER ISO 14644-1
Cleanrooms and associated controlled environments - Monitoring to provide evidence of
cleanroom performance related to air cleanliness by particle concentration - ANSWER
ISO 14644-2
Cleanrooms and associated controlled environments - Test methods - ANSWER ISO
14644-3
Cleanrooms and associated controlled environments - Design, construction and start-up
- ANSWER ISO 14644-4
International Organization of Standards - ANSWER ISO
Controlled Environment Testing Association - ANSWER CETA
Certification Application Guide - ANSWER CAG
Institute of Environmental Sciences and Technology - ANSWER IEST
United States Pharmacopeia - ANSWER USP
Food and Drug Administration - ANSWER FDA
High Efficiency Particulate Air - ANSWER HEPA
, Primary Engineering Control - ANSWER PEC
Direct Compounding Area - ANSWER DCA
Standard Operating Procedure - ANSWER SOP
Laminar Air Flow Workbench - ANSWER LAFW
Colony-forming Unit(s) - ANSWER cfu
Beyond-Use Date - ANSWER BUD
Air Changes per Hour - ANSWER ACPH
Biological Safety Cabinet - ANSWER BSC
Trypticase Soy Argar - ANSWER TSA
Feet per Minute - ANSWER FPM
Cubit Feet per Minute - ANSWER CFM
Micro-Grams per Liter - ANSWER ug/L
Micron - ANSWER µm
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 Chrisyuis. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.99. You're not tied to anything after your purchase.