FDA-registered, cGMP-compliant facility in Rogersville, TennesseeResourcesFAQ423-921-0202john@mbmpack.com

Home / Resources / Glossary

Carton and serialization glossary

Terms you'll see on carton specifications, proofs, and quality documents.

Acetate overlay
A clear film printed with a carton's dieline and key print positions, laid over a received carton to check it against the specification.
Batch record
The production record for a run, including lot number, materials, and process data, used for traceability.
Bleed
Artwork extended past the cut line so no unprinted edge shows after cutting. Standard bleed is 1/8 inch.
Caliper
The thickness of paperboard, measured in points (thousandths of an inch). An 18 pt board is 0.018 inch thick.
CCNB
Clay-coated news back: a recycled paperboard with a coated white printing surface.
Certificate of Conformance (CoC)
A signed statement that an order meets all specified requirements.
Crease (score)
A pressed line that lets paperboard fold cleanly without cracking.
Dieline
The flat drawing of a carton showing cut and crease lines, used to lay out artwork and drive cutting.
Digital flatbed cutting
Cutting and creasing directed by a digital file instead of a steel-rule die, which removes die cost on short runs.
DSCSA
The Drug Supply Chain Security Act, a federal law requiring a product identifier, including a serial number, on prescription drug packages for tracing.
Dust flap
A small side flap that closes the end of a carton under the tuck flap.
GS1 DataMatrix
A square 2D barcode that holds encoded data such as GTIN, serial, lot, and expiry. It is the standard code for DSCSA product identifiers.
GTIN
Global Trade Item Number: the GS1 product identification number encoded in barcodes.
IFU
Instructions for Use: the regulated document packaged with a medical device or drug.
Incoming receiving inspection (IRI)
The check a manufacturer performs on purchased components when they arrive, before releasing them for use.
Lot traceability
The ability to link each finished item to its production run, materials, and records.
Make-ready
Press and die setup before the first good sheet. Digital production needs very little of it.
Miniature folding
Folding an insert or outsert into a very small, tight package that fits inside or on a carton.
NDC
National Drug Code: the FDA identifier for a drug product, carried inside the GTIN on U.S. prescription drug packages.
Outsert
A tightly folded insert attached to the outside of a container or carton.
Packaging Parts Specification (PPS)
A controlled document defining a packaging component: dimensions, structure, material, print, and acceptance criteria.
Reverse tuck end (RTE)
A carton whose top and bottom tuck flaps close from opposite sides.
SBS
Solid bleached sulfate: a premium, all-virgin-fiber white paperboard common in pharmaceutical cartons.
Serialization
Printing a unique identifier on each unit so it can be tracked individually.
Straight tuck end (STE)
A carton whose top and bottom tuck flaps close from the same side.
UDI
Unique Device Identification: the FDA system requiring medical device labels to carry a unique identifier in machine- and human-readable form.
Variable data printing
Printing different information on each piece, such as serial numbers or codes, within one run.

Ready to spec your next run?

Cartons from 50 units, IFUs from 1,000. Quotes within one business day.

Request a quote