COSMETIC AND PHARMACEUTICAL PACKAGING TESTING
The laboratory has experience and also deals with evaluations on other materials used industrially or consumer goods, not intended for contact with food
Food Contact Center is also specialized in the validation of packaging intended for contact with drugs or pharmaceutical forms, and actively collaborates in the technical commission held within the Italian Packaging Institute on the validation of pharmaceutical packaging; in addition to the aspects defined by the pharmacopoeia, risk assessment is increasingly based on typical rules of compliance with food contact.
In the food contact contest, for the investigation of unintentionally added substances, reference is made to the acronym NIAS.
In the cosmetic contest, for the investigation of unintentionally added substances, reference is made to the terms Leachables & Extractables.
The materials that make up the packaging could contaminate medicines by interaction between the medicine and the container. The American Pharmacopoeia defines the risk and assessment related to these interactions in chapters “1663: Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems” and “1664: Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging / Delivery systems”.
Let’s see some definition of the terms used in Cosmetic packaging: extractables (“extractable” components) are organic and inorganic chemicals that can be released from a drug packaging or delivery system, a component of a packaging or packaging material under specific conditions during laboratory testing. Depending on the specific purpose of the extraction study, these test conditions (e.g. solvent, temperature, etc.) can accelerate or amplify the normal storage and use conditions for a packaged medicine. Extractables themselves, or substances derived from extractables, have the potential to migrate into a pharmaceutical product under normal conditions of storage and use.
Leachables (“leachable” components) are organic and inorganic chemicals that can be released from a drug packaging or delivery system, a component of a packaging or packaging material under normal storage and use conditions or during accelerated studies of stability of the pharmaceutical product. The “leachable” components are generally a subset of extractables, or derive from extractable substances. Note that chemicals can also migrate from packaging or release systems to patients via direct contact.
It is therefore clear that in order to evaluate the truly leachables – “leachable” substances during the life of the drug, laboratory studies must be performed to evaluate extractables – “extractables”.
Despite the nuances related to the official definitions, from a practical point of view we often talk about Extractables & Leachables analysis. In recent years, regulatory demands relating to the evaluation of Extractables & Leachables from packaging or process components or finished products have grown considerably in the Pharma sector. Substances can migrate from different materials (polymers, adhesive glues and inks, coated and uncoated metallic materials, glass, etc.) and patients could therefore be exposed to contaminants through the different routes of administration. Simultaneously with the research phases for the synthesis and evaluation of efficacy and safety of the drug, it is essential to evaluate the potential risk of E&L for the various types of chemical substances that could migrate from the closure of the container, from different components of the packaging or even from the systems. of production in pharmaceutical and biological products.
The risk assessment and the consequent toxicological assessment are factors of absolute importance, necessary to guarantee the safety of pharmaceutical products.
Food Contact Center tests packaging intended for contact with cosmetics, and actively collaborates in the technical commission held within the Italian Packaging Institute (institutional) on the validation of cosmetic packaging; In this regard, it must be said that even if the Cosmetics Regulation has invited to base the risk assessment on typical rules of compliance with food contact, cosmetics often have very different chemical and physical characteristics compared to foods; for example some cosmetics are basic or oxidizing, and this involves a different interaction with packaging.
Hence, the work of validating cosmetic packaging must often consider these aspects as well; it is necessary to evaluate the formulations of cosmetics, their use in contact with different materials and the simulant to be used in the tests, which is not always the food simulant
Some tests carried out by the Food Contact Center have shown that basic and / or oxidizing substances lead to degradation of materials and their additives. It is necessary to carry out an accurate RISK ASSESSMENT
Dr. Marinella Vitulli has presented in many congresses the activities carried out in synergy with the Technical Commissions.