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The validation of packaging stems from the need to ensure the quality of products across the many steps in your distribution cycle: from shipping to storage. It is indeed an increasingly common requirement for many product categories, including a strong emphasis on the packaging quality requirements for medical and pharmaceutical industries.

Good Manufacturing Practices (GMP) are vital standards in the pharmaceutical industry that ensure product quality and safety throughout production. These regulations protect against contamination, errors, and deterioration, ensuring that healthcare products consistently meet strict standards.

Steam sterilisation is a highly effective and reliable method of decontamination. By exposing products to saturated steam at high temperatures—typically between 121°C and 134°C—steam sterilisation ensures the elimination of harmful microorganisms. The process involves three critical phases: conditioning, exposure, and exhaust, with exposure times ranging from 3 to 15 minutes, depending on the specific product requirements.

Good Distribution Practices (GDP) are essential regulatory standards in the pharmaceutical industry that ensure the quality and safety of products throughout their logistical journey. These standards cover the transportation and distribution of healthcare products, preventing risks such as contamination, falsification, or product deterioration.

Medistri is attending Pharmapack 2025 in Paris, France from January 22 to 23, hosting a booth to cater client meetings, showcase its services and answer all questions.

EO Sterilisation is particularly beneficial for products that cannot be subjected to high heat or moisture, making it an ideal solution for many modern medical devices and pharmaceutical products. Here’s how it works in practice for different types of products that are in their definitive package.

The MDR (Medical Device Regulation) certification for sterile kits refers to the regulatory requirements that apply to the manufacturing, distribution, and use of medical devices, including sterile kits, within the European Union. Sterile kits often consist of a combination of medical devices, instruments, or other items assembled into a single product for medical procedures. It sets forth requirements for the design, manufacture, and distribution of medical devices to ensure their safety and effectiveness.

A pharmaceutical vial is a small container, typically made of glass or plastic, used to store and protect liquid, powder, or lyophilized (freeze-dried) pharmaceutical substances. These vials must be sterilized and sealed with a rubber stopper or a screw-on cap, often secured by a metal crimp or seal. They are commonly used for injectable medications, vaccines, or other substances requiring precise dosing. Vials ensure the contents are protected from contamination and maintain sterility until use.

Ethylene oxide (also known as EO or EtO) is a low temperature gaseous process widely used to sterilize a variety of healthcare products, such as single-use medical devices. Through the use of a vacuum-based process, EO can efficiently penetrate surfaces of most medical devices and its lower temperature makes it an ideal process for a wide variety of materials.

MTT Assay is a colorimetric assay that measures the metabolic activity of cells as an indicator of their viability. By leveraging the cell's natural enzymatic processes, this assay transforms a yellow tetrazolium salt (MTT) into insoluble purple formazan crystals. These crystals only form in cells with active metabolism, offering a direct correlation between formazan production and the number of living cells.