Adapting to the new GMP Annex 1 represents a key challenge for the pharmaceutical industry, as it establishes demanding standards for the manufacture of sterile drugs. This framework regulates everything from facility design to environmental monitoring, fostering continuous improvement and patient safety. In this article, we explore how to transform this challenge into a strategic opportunity to optimize processes and ensure regulatory compliance.

From air cleanliness specifications to data recording by computer systems… Designing a cleanroom involves complying with multiple international and industry regulations. In this article, we look at key standards such as ISO 14644 and GMP, as well as environmental regulations that drive sustainability and energy efficiency in this type of facility.

GMP Annex 1 establishes the essential requirements for sterile processes in the pharmaceutical industry. From environmental control to equipment validation, compliance with it ensures safety and quality in manufacturing environments. In this article, we discuss its key guidelines and their impact on sterile drug production.

HEPA and ULPA filters are essential in cleanroom HVAC systems, ensuring the removal of ultrafine particles and contaminants. Discover their characteristics, operating principles and key differences, as well as their importance in regulated industries and challenges such as energy efficiency.

The history of cleanrooms is a fascinating journey through the quest for controlled, contaminant-free environments.

This article presents an overview of some of the most important milestones that have led to today’s advanced cleanrooms, which are essential for scientific and technological progress.

Clean rooms are critical spaces for sectors where even the slightest contamination can compromise quality and safety. In this article, we explore their general characteristics and operation, as well as their design and installation process, among others.