Cleanroom Compliance
The Angstrom team can offer a full range of specialist services and support for all Clean and Controlled Environments, suitable for all levels of budget and classifications of projects throughout the UK and Europe.
Our teams are very knowledgeable of industry standards for Clean and Controlled Environments, and work with the whole project team to ensure all required standards are assessed and incorporated into any proposal.
Learn more about Cleanroom Compliance
Take a look at our resources
Our GMP team
With over 30 years’ combined experience in GMP & pharmaceutical industries, our in-depth knowledge and practical expertise ensure your cleanroom meets the necessary regulatory standards, your process requirements and guarantees product quality and safety.
GMP Consultancy services
Our GMP Consultancy Services are designed to support cleanroom users in navigating the complexities of Good Manufacturing Practice (GMP) requirements.
Cleanroom Validation
Our team has over 30 years’ combined experience in GMP & pharmaceutical industries and provides oversight on the entire validation process to make sure you have everything you need for a successful audit.
Requalification to GMP Annex 1
There has been a significant change to the guidance for validations and requalification in Annex 1. Previously, qualification was recommended to be completed to the ISO 14644 series of standards. Now, Annex 1 details the testing that is expected in the initial qualification, then what is needed as part of the requalification.
EU GMP Annex 1 compliant cleanroom design & build
Guidance on cleanroom construction materials, transfer protocol, airlocks, pressure differentials, and more has changed. The Angstrom team are able to advise you during the design process so that both your process requirements and the new guidance is met.
Initial qualification to GMP Annex 1
Annex 1 now details the testing that is expected in the initial qualification, then what is needed as part of the requalification.
