Packaging Regulations & Standards Flashcards
7 cards from real CPP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Packaging Regulations & Standards flashcards as text
What is the primary difference between ISTA 2A and ISTA 3A test protocols?
Answer: 2A uses fixed test sequences while 3A uses statistically derived intensity levels
ISTA 2A uses fixed, general simulation test sequences, while ISTA 3A uses statistically derived, more precise intensity levels based on actual distribution data.
Under 21 CFR 211.94, what is required of drug product containers and closures?
Answer: They must not be reactive, additive, or absorptive so as to alter drug safety or efficacy
21 CFR 211.94 requires that drug product containers and closures not be reactive, additive, or absorptive in a manner that will alter the drug's safety, identity, strength, quality, or purity.
Which standard defines the test methods for measuring the oxygen transmission rate (OTR) of plastic film and sheeting?
Answer: ASTM D3985
ASTM D3985 is the standard test method for oxygen gas transmission rate through plastic film and sheeting using a coulometric sensor.
The Sustainable Packaging Coalition's How2Recycle label program requires what before a package can display the label?
Answer: Packaging must pass third-party recyclability assessment
How2Recycle requires packages to undergo a third-party recyclability assessment to determine the appropriate recycle label based on actual collection infrastructure.
Under 49 CFR 173.24, what is a general requirement for packaging used to transport hazardous materials?
Answer: Packaging must be compatible with the hazardous material it contains
49 CFR 173.24 requires that packaging be compatible with its hazardous material contents—it must not react, deteriorate, or be significantly weakened by the material.
Which regulation governs the use of recycled plastic in direct food contact applications in the United States?
Answer: FDA 21 CFR 177.1520
FDA 21 CFR 177.1520 covers olefinic polymers including recycled plastics; FDA also issues letters of non-objection for specific recycled plastic processes used in food contact.
What does the 'Y' suffix in a UN packaging marking (e.g., 4G/Y) indicate?
Answer: The packaging is suitable for Packing Groups II and III only
The 'Y' suffix in UN packaging markings indicates the package is authorized for Packing Groups II and III, but not the most dangerous Packing Group I materials.