Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing : Current
Good Manufacturing Process - U.S. Department of Health and Human Services
A. Acronym: NIOSH
B. Used for: __________ - A. National Institute of Occupational Safety and Health
IEST-RP-CC013.2 - Calibration Procedures and Guidelines for Select Equipment Used
in Testing Cleanrooms and Other Controlled Environments
IEST-RP-CC034.3 - HEPA and ULPA Filter Leak Tests
ISO 14644-1 - Cleanroom and Associated Controlled Environments - Classification of
Air Cleanliness by Particle Concentration
ISO 14644-2 - Cleanroom and Associated Controlled Environments - Monitoring to
Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle
Concentration
ISO 14644-3 - Cleanroom and Associated Controlled Environments - Test Methods
,ISO 14644-4 - Cleanroom and Associated Controlled Environments - Design,
Construction and Start-up
ISO - International Organization of Standards
CETA - Controlled Environment Testing Association
CAG - Certification Application Guide
IEST - Institute of Environmental Sciences and Technology
USP - United States Pharmacopeia
FDA - Food and Drug Administration
HEPA - High Efficiency Particulate Air
PEC - Primary Engineering Control
DCA - Direct Compounding Area
SOP - Standard Operating Procedure
LAFW - Laminar Air Flow Workbench
cfu - Colony-forming Unit(s)
BUD - Beyond-Use Date
ACPH - Air Changes per Hour
BSC - Biological Safety Cabinet
TSA - Trypticase Soy Argar
FPM - Feet per Minute
CFM - Cubit Feet per Minute
ug/L - Micro-Grams per Liter
µm - Micron
dB - Decibel
DP - Differential Pressure
, CACI - Compounding Aseptic Containment Isolator
CAI - Compounding Aseptic Isolator
OSHA - Occupational Safety and Health Administration
ASHP - American Society of Hospital Pharmacists
Critical aArea a- a aISO a5 aEnvironment
How aoften, aat aa aminimum, ashould aBuffer aRoom afloors abe acleaned?
A. aDaily
B. aWeekly
C. aHourly
D. aYearly a- a aA. aDaily
How aoften, aat aa aminimum, ashould aAnte aRoom afloors abe acleaned?
A. aDaily
B. aWeekly
C. aHourly
D. aYearly a- a aA. aDaily
How aoften, aat aa aminimum, ashould aBuffer aRoom aShelves abe acleaned?
A. aDaily
B. aWeekly
C. aMonthly
D. aYearly a- a aC. aMonthly
How aoften, aat aa aminimum, ashould aBuffer aRoom aceilings abe acleaned?
A. aDaily
B. aMonthly
C. aHourly
D. aYearly a- a aB. aMonthly
How aoften, aat aa aminimum, ashould aBuffer aRoom awalls abe acleaned?
A. aDaily
B. aWeekly
C. aHourly
D. aMonthly a- a aD. aMonthly
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 Mboffin. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.99. You're not tied to anything after your purchase.
