What is EN ISO 13452: 2019 ?

EN ISO 13408-2: 2019 is a crucial standard for pharmaceutical companies that produce and distribute sterile barrier systems for medical applications. This article will provide an overview of the standard and its significance in ensuring the safety and quality of pharmaceutical products.

EN ISO 13408-2: 2019 is a technical standard that focuses on the validation and control of sterile barrier systems used in the production of medicinal products. These systems are critical in ensuring the integrity and sterility of medicinal products, particularly those that are terminally sterilized. By adhering to the requirements outlined in the standard, pharmaceutical companies can minimize the risk of contamination, maintain product quality, and ensure the safety of patients who rely on their products.

The primary purpose of EN ISO 13408-2: 2019 is to establish guidelines for the validation and control of sterile barrier systems used in pharmaceutical manufacturing processes. These systems are designed to ensure the integrity and sterility of medical products. EN ISO 13408-2: 2019 provides guidance on various aspects of sterile barrier system design, testing, and monitoring, helping manufacturers implement robust processes and systems that comply with regulatory requirements.

EN ISO 13867: 2019 is another important standard that is relevant to the production and quality control of plastic films. This standard provides guidelines for measuring the length of a polymer melt that is extruded through a die in order to produce plastic film or sheeting. By understanding the principles and requirements of this standard, companies involved in the production and quality control of plastic films can ensure accurate and consistent measurement results across different laboratories and manufacturers.

In conclusion, EN ISO 13408-2: 2019 and EN ISO 13867: 2019 are essential standards for pharmaceutical companies that produce and distribute sterile barrier systems for medical applications. These standards provide guidelines for the validation and control of these systems and ensure that the measurements obtained are reliable, comparable, and meet the industry's requirements for quality control and product consistency. Compliance with these standards is critical for ensuring the safety and quality of pharmaceutical products.