The Healthcare Compliance Packaging Council

The Healthcare Compliance
Packaging Council

HCPC Glossary

Confused by all the packaging terminology when looking for compliance-prompting packaging? We've compiled a list of frequently used terms to assist you.

Glossary of Pharmaceutical Packaging Terms

A

  • Aclar® : Honeywell International, Inc.'s registered trade name for high barrier films made from PCTFE (polychlorotrifluoroethylene) resins.
  • Ampule : A glass container filled with medication and closed with a rubber stopper.
  • ANDA : Abbreviated New Drug Application (filed with the FDA).
  • Aspetic : Sterile

B

  • Bar Code : A way of labeling or coding a product that allows a clear description of the contents and limits dosage mistakes. Bar codes can only be read by scanners.
  • Barrier : Protection from deterioration or ingress of moisture through package material.
  • Bingo Card : A blister pack sealed into a fold-over card.
  • Blister Pack : A unit dose package commonly constructed from a formed cavity containing one or more individual doses.
  • Bottles : Glass or plastic containers used to package solid or liquid pharmaceutical products.

C

  • Calendar Blister : A blister package designed to facilitate a patient's memory by incorporating the day/time that each dose is to be taken into the package design.
  • Capsule : Solid dose medication filled into gelatin halves and pushed together; easy to swallow.
  • Compliance : Adhering to a prescribed regimen. Taking one's medication properly.
  • CPSC : Consumer Product Safety Commission. The Federal agency responsible for implementing the Poison Prevention Packaging Act of 1970.
  • CR : Child Resistant, indicates that a package will pass a test protocol administered by the U.S. Consumer Product Safety Commission.

D

  • Desiccant : Highly hygroscopic substance used to absorb moisture in bottles, vials and blisters.
  • Dial-Pack : Commonly used for oral contraceptives, this type of package utilizes a calendar design such that a dial must be turned each day to remove a tablet.
  • Dosage : Prescribed amount of medication to be taken.

E

  • Expiration Date : The date until a pharmaceutical product is safe to be consumed.

F

  • FFS : Form Fill Seal
  • Foil: Thin gauge aluminum, typically 20-25 micron, used as a push-through lidstock available as hard tempered and soft. Can be printed on two sides in multicolor.

G

  • GelCap: A gelatin-coated capsule which is easier to swallow, and is tamper evident.
  • Generic: Rx or OTC drugs which are no longer protected by a patent.
  • GMP: Good Manufacturing Practices (as established by the FDA).

H

  • HMO: Health Maintenance Organization.
  • HUD: Hospital Unit Dose packages intended for use by in-patient hospital pharmacies.

I

  • INDA: Investigational New Drug Application.

L

  • Lidding Stock: Material used to seal a blister to prevent or minimize moisture/gas permeation.
  • Lot Number: A number that is assigned to a production batch so that all of a product's components can be traced.

M

  • Machinability Test: A test done to review the performance of blister components to optimize actual production runs, and find the best machine settings for individual materials.
  • MVTR: Moisture Vapor Transmission Rate -- the amount of moisture that is transmitted through packaging film or foil over a set period of time.
  • Mylar®: The registered trade name of Dupont's polyester film.

N

  • NDA: New Drug Application (must be submitted to the FDA for approval to manufacture and market the drug.
  • Noncompliance: Not taking one's medication properly.

O

  • OPD: Original Pack Dispensing. A pharmaceutical product that is dispensed to the patient in the manufacturer's original package (i.e., not repackaged by a pharmacist or anyone else).
  • OTC: Over the Counter Drugs -- available without a prescription.

P

  • Physician Sample: See trial size.
  • Polypropylene: A monolayer blister film used for pharmaceutical packaging. Use of this film may require machine or tooling modifications.
  • Pouches/Sachets: A flexible material (usually paper, foil, PE, PET or a multi-laminate) used to package medication.
  • PVC: Polyvinyl Chloride. Commonly used for blister packaging of solid and liquid dose products.

R

  • Relieved Area: An area that is predesigned into a package for easier openings.
  • Rx: Drugs that require a doctor's prescription for legal dispensation.

S

  • SF: Senior Friendly -- easier for older people to handle and open.
  • SNDA: Supplemental New Drug Application.
  • Solid Dose: Non-liquid dosages such as tablets, capsules, caplets, etc.
  • Stability Testing: The process used to confirm the efficacy of individual medicines for a set time within a given package under elevated humidity and temperature conditions.
  • Strip Pack: A package used to protect solid dose pharmaceutical products, and to provide relatively inexpensive protection for individual dosages.

T

  • Tamper Evident: One or more safety features used to indicate that a package is not in the original condition as it was when shipped from the manufacturer or packager.
  • Tolerance: Minimum/maximum range of measurement.
  • Transmission: Quantity of moisture and/or gas passing through the packaging film or foil over a specific period of time.
  • Trial Size: Sample of a drug given to the patient by a doctor in a blister, strip pack or small bottle for patient to try medication. Free of charge. Also known as physician sample.
  • Tyvek®: The registered trade name for Dupont nonwoven polyethylene material that can be used as a breathable barrier or as lidstock which is difficult to tear.

U

  • Unit Dose: The prescribed amount of each dosage in a package.
  • Unit of Use: The exact amount of a drug's treatment pre-packaged by the manufacturer or pharmacist in standardized amounts.
  • USP: United States Pharmacopoeia (a standard setting body).

V

  • Vial: Glass or plastic container filled with medication.

This information is true and accurate to our best knowledge. Any recommendations or suggestions are without guarantee, since the conditions of use are beyond our control. There is no implied warranty or merchantability for purpose of any product described herein. In submitting this information, no liability is assumed for licensed or other rights, nor expressed or implied with respect to any existing or pending patent, patent applications or trademarks. Observance of all legal regulations and patents is the responsibility of the user.