The Building Blocks of Cleanroom Compliance: Steering Regulatory Considerations through Project Lifecycles

In the meticulously controlled world of cleanrooms, every design element and construction phase is a testament to precision and compliance. Whether serving the pharmaceutical, biotechnological, or electronic sectors, cleanrooms are the bedrock of controlled, contamination-free environments crucial for product reliability and safety. In the UK, steering a cleanroom project from blueprint to operational readiness demands […]

New Annex 1 Requirements

The newly revised Annex 1 requirements, set to come into effect on August 25, 2023, signify a substantial step forward in the regulation of cleanroom environments, particularly in the manufacture of sterile medicinal products. Here’s a detailed look at the pivotal updates in the new Annex 1 requirements: Contamination Control Strategy (CCS): One of the […]

New Annex 1 Requirements and Practical Changes Within Cleanrooms

The amendments stipulated in the new Annex 1 requirements will manifest in several practical changes within cleanrooms, especially those involved in the manufacture of sterile medicinal products. Here are some real-world examples of how these changes might take shape: Implementation of a Contamination Control Strategy (CCS): Cleanrooms will now have a structured Contamination Control Strategy […]