Engineering Company Sterils Group works to develop concept designs and layouts based on clients business requirements. Fully conversant with the local regulatory requirements, our designers will ensure full compliance whilst incorporating the specific needs of different projects into an innovative solution.
Sterils Group provides a one-stop source for the successful implementation of any cleanroom development project from concept to completion. With extensive industry knowledge that spans the entire cleanroom development process, Sterils Group enables organizations to successfully implement their cleanroom project on time and on budget.
The diversity of our people is key to the success of our projects. Selected from a variety of industry backgrounds they contribute best practice and fresh ideas, to guarantee the best value solutions are explored and identified. Whatever their role, project management is their core skill, ensuring we deliver on time, within budget and to our clients’ requirements.
Both our in-house core team and our specialist supply chain are also very stable. As the business has developed, our people and our suppliers have grown with us, so that our clients can benefit from continuity of relationships, established teams and retained experience and understanding.
Sterils Group offers a wide range of market-leading materials, constructions and solutions that are notable for their high quality standards, matched by durability and reliability.
Standards and Compliance
Up to date knowledge of the current cleanroom and construction standards is an operational and contractual necessity for constructing clean environments. Sterils Group stays up-to-date with current regulations and upcoming revisions to ensure our designs and installations are in line with the latest requirements, wherever we are operating.
Our comprehensive experience of rules, guides, regulations and best practices includes:
• ISO 14644-1, parts 1-5: Clean rooms and associated Controlled Environments. Classification of Air Chambers.
• EU GMP; Rules & Guidance for Pharmaceutical Manufacturers & Distributors 2007. MHRA. ISBN 978-0-85369-719-0 and amendment dated February 2008
• ATEX; AmospheresExplosibles directive
• Code of Practice for Tissue Banks, Department of Health (UK)
• DSEAR: Dangerous Substances and Explosive Atmospheres Regulations
• Guidance of the Microbiological Safety of Human Organs, Tissues & Cells used in transplantation, Advisory Committee on the Microbiological Safety of Blood & Tissue Transplantation MSBT The Management, Design & Operation of Microbiological Containment Laboratories, Advisory Committee on Dangerous Pathogens.
Besides the above clean environmental regulations, guidance and best practices, we also design our facilities to comply with local building control and site management regulations and can assist with planning an fire officer approvals.