What is BS EN ISO 15747:2016?

In the world of technical standards, BS EN ISO 15747:2016 is a significant one. It is a standard that deals specifically with packaging for medicinal products. This article aims to provide an easy-to-understand explanation of what this standard entails and its importance in the pharmaceutical industry.

The Purpose of BS EN ISO 15747:2016

BS EN ISO 15747:2016 sets out guidelines for the design and testing of packaging materials used for medicinal products. Its primary purpose is to ensure the safety and integrity of these products throughout the supply chain. Packaging plays a crucial role in protecting medicines from any potential contamination or damage, thereby guaranteeing their efficacy and quality. By adhering to this standard, pharmaceutical companies can minimize risks associated with product degradation, tampering, and counterfeiting.

Key Requirements of the Standard

This standard outlines several essential requirements that packaging materials must meet. First and foremost, they must be compatible with the product they are intended to contain. Compatibility refers to factors such as chemical interactions between the packaging material and the medicinal product. The standard also addresses issues like temperature resistance, moisture control, and light protection. Furthermore, it specifies criteria for child-resistant packaging and tamper-evidence features to safeguard against accidental ingestion or unauthorized access.

The Impact on the Pharmaceutical Industry

The implementation of BS EN ISO 15747:2016 has brought about positive changes in the pharmaceutical industry. By promoting standardized and reliable packaging systems, it has enhanced the overall quality and safety of medicinal products. Pharmaceutical manufacturers now have clear guidelines to follow when selecting and assessing packaging materials, allowing for better decision-making and risk management. Furthermore, this standard has fostered international harmonization, ensuring that packaging practices are consistent across borders and reducing barriers to trade.

In conclusion, BS EN ISO 15747:2016 is a crucial standard that addresses the packaging requirements for medicinal products. Its purpose is to safeguard the safety, integrity, and quality of these products throughout the supply chain. By adhering to this standard, pharmaceutical companies can minimize risks associated with product degradation and enhance patient safety. The impact of this standard has been significant in ensuring standardized packaging practices and facilitating international trade.