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Life Science & Pharmaceutical Cleanrooms
Angstrom Technology can offer design and installation support for all clean, controlled environments of the pharmaceutical industry, from small-scale R+D to final packaging.
Examples of applications include:
- Excipients and API manufacturing
- Powder handling (ATEX rated)
- Wet and dry granulation
- Micronising
- Tabletting
- 3D printing – Artificial Intelligence (AI)
- Opening up space – Obstructed free areas or packing halls
Regulatory compliance
Projects are designed, installed and validated to the industry guidelines and standards set out by the relevant regulative authorities, including EU GMP, cGMP, MHRA, FDA, and ISO 14644 Cleanroom Standards.
Whether your project is biotech, laboratory-based, or large-scale, patented bulk final drug manufacturing facilities, we have the knowledge and experience to support a regulatory-compliant project. We can also help by assisting the management of the project or the client’s team to ensure that the project is technically the best achievable and that budget and timeline targets are met.
Build & refurbishment
Angstrom works with both new build and refurbishment projects, and we fully understand that production is king! We operate to minimise production downtime during and after the project. We can support the smaller projects or planned defect rectification works using our small works team or deliver a new facility with our total solution project team structure.
Pharma Compliance & Validation Support
GMP compliance and regulatory validation are non-negotiable in life sciences. Our specialists guide you through design, qualification, and ongoing compliance requirements.
Frequently Asked Questions
We design and build cleanrooms and controlled environments for a range of life science and pharmaceutical applications, such as pharmaceutical manufacturing, quality control laboratories, and research and development facilities.
Pharmaceutical manufacturing must follow Good Manufacturing Practice, with EU GMP Annex 1 setting specific requirements for sterile products. In the UK, compliance is inspected by the MHRA. Cleanroom air cleanliness is also classified under ISO 14644-1.
Depending on your process, cross-contamination can be controlled through differential pressure cascades, airlocks, segregated personnel and material flows, and appropriate gowning arrangements. These measures are defined early in the design stage, based on your User Requirement Specification.
In many cases, yes. We begin with a detailed survey of your existing space to assess what is achievable, then design the upgrade around your required grade, your process, and your building’s existing services.
Yes. We provide cleanroom validation through Design, Installation, Operational, and Performance Qualification, along with a full documentation package. This gives you the evidence you need to demonstrate your facility’s performance during MHRA inspections or client audits.