The quality and safety of medicines and Medical Devices do not depend only on the active principles and materials that make up the products but also on the packaging components.

The packaging of medicines and Medical Devices is divided into:

• Primary: in direct contact with the product itself. Its main purpose is to preserve the integrity preventing the penetration of external factors, in particular light and air, and to ensure packaging safety during its different transit stages
• Secondary: it includes the primary packaging (blister packs, bottles, sachets, etc.) and it too has the task of protecting the product from external factors in addition to displaying information of the medicine or Medical Device

The primary packaging must meet specific requirements, as it must not transfer potentially harmful substances to the product and must preserve sterile conditions, where appropriate.

To evaluate the toxicological risk, it is necessary to carry out Leachables and Extractables studies, i.e. studies on the compounds that can be extracted with aggressive conditions (temperature and solvents) and compounds that can migrate from the packaging during normal conditions of use and storage such as Bisphenol A, phthalates, plasticisers, and heavy metals.

The reference standards for laboratory testing are the ISO 10993 series on the biocompatibility of Medical Devices and the United States Pharmacopoeia (USP) on plastic materials in contact with food (Class VI certification). The guidelines differ depending on if the testing is on the pharmaceutical packaging or the Medical Device, but they are based on the same principles.

As regards sterile Medical Devices, EU Regulation No 2017/745 (MDR) sets out that they must be designed, produced and packaged in line with validated procedures and methods to ensure that they are sterile and remain sterile during transport and storage and until expiry date.

To prove that the packaging is in line with the safety requirements set out in the applicable regulations, the necessary testing must be carried out in compliance with UNI EN ISO 11607-1:2020 standard: 'Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems'. This standard provides some important definitions:

• SBS (Sterile Barrier System): The minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use
• Protective Packaging: Set of materials designed to prevent damage to the sterile barrier system and its contents
• Packaging System: Set of SBS and protective packaging

These definitions should be taken into consideration even during the testing stage to choose the most appropriate testing strategy.