Glossary - Pharmaceutical Packaging
Defined as the “quality level that is the worst tolerable” (ISO 2859-1), the AQL is the highest amount of defective components considered acceptable for a delivered quantity (batch) The verification of the Quality level is based on statistical sampling described in the ISO-norm.
Also known as biologics or biopharmaceuticals, biologic drugs are manufactured by or extracted from biological raw material, rather than chemically synthesized. Biologics are a rapidly expanding area of medicine, which includes vaccines, blood components, and gene therapy.
Invented in 1887 by SCHOTT founder Otto Schott, borosilicate glass is used for a wide range of drug containers, as well as laboratory glassware. Made using mainly silica and boron trioxide, its low coefficient of thermal expansion and high chemical and thermal resistance makes it first choice for pharmaceutical packaging.
A document produced by a manufacturer that provides an overview of test results performed on a product. Essential for all drugs and drug containers, the certificate ensures conformity with mentioned laws and regulations like pharmacopeiae (Ph.Eur., USP, JP).
Crucial for all pharmaceutical packaging, the Defect Evaluation List provides manufacturers and cutomers with a series of documents that describe possible packaging defects, alongside details of testing procedures and sampling tables. (Defect Evaluation List for Containers made of Tubular Glass, vol. 19, 4th edition, Editio Cantor Verlag 2016, authors M. Harl, S. Horst, M. Polan; ISBN 978-3-87193-434-6)
A compilation of documents that details the complete design and development activities of a medical device. Produced by the manufacturer, it demonstrates that the design was developed according a design control process to meet the requirements of health authorities and customers.
A pharmaceutical syringe that requires filling by the medical professional before it can be administered. When used with a vial filled with the required drug, this is the conventional method of administering medication.
A container for storing parenteral drugs, such as a syringe, vial, ampoule, or cartridge. Since the quality and integrity of a drug needs to be maintained during fill and finish, transportation, and storage, most drug containment solutions are made of glass thanks to its high chemical, thermal, and mechanical resistance, as well as its high geometrical tolerance.
The pharmaceutical system that administers a drug into the body, such as a syringe. The drug delivery system must offer stable storage of the drug, as well as safe, hygienic, and reliable administration of the drug into the patient.
Evaluated by the European Medicines Agency (EMA), the EMDR ensures that all medical devices developed for use in the European Union meet legal requirements to ensure they are safe and perform as intended. Once a device passes the EMDR conformity assessment, the manufacturer can place the CE (Conformité Européenne) mark on the device.
As essential pair of quality criteria for pharmaceutical packaging, extractables and leachables refer to the organic and inorganic chemicals released from the materials used in drug containment under direct contact with solvents. Extractables are compounds extracted from the containment solution in presence with a solvent. Leachables are compounds leached into the drug product formulation as a result of direct contact. The results of E&L studies are crucial in determining the stability of a drug container and long-term safety of a drug.
A classification that indicates a drug is especially sensitive to air, water, heat, and/or chemicals. Common examples are biologic drugs derived from living organisms, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, fusion proteins, and drugs for gene and stem cell therapy. Typically stored in much smaller quantities than chemical drugs, highly sensitive drugs require pharmaceutical packaging with specific adoptions of chemical and thermal container properties.
Also known as freeze drying, lyophilization is the process in which water is removed from a product during a freezing process under vacuum conditions. Lyophilization offers many advantages for the storage of drugs, including easier processing and handling, improved stability, and rapid reconstitution.
Traditionally defined as the branch of analytical methods that deal with drugs and drug contact materials, pharma analytics is now a broad area that takes in the identification of pharmaceutical drugs, their purity, chemical structure, and properties, and how they can be influenced under different conditions. For drug containers, a wide range of analytical testing methods can determine material properties and behavior to ensure a container is suitable for a specific drug product, as well as solve root-cause challenges and prepare regulatory-compliant evidence for drug product submissions to national health authorities.
In the general pharmaceutical area, ready-to-use refers to a drug product in the right volume and concentration to be administered to a patient. Ready-to-use containers, such as vials, syringes and cartridges, are pre-sterilized drug containment and delivery solutions able to go straight into the fill- and-finish process without further processing steps.
Sterile water that’s suitable for use as a solvent for drugs administered into the human body. Water for injection can be produced by three different methods: multiple effect distillation, vapor compression distillation, and membrane-based systems.