Expert Cleanroom Consulting Services
W2 Cleanroom Consulting provides specialist support across every stage of your cleanroom and aseptic manufacturing journey. From concept design and validation to governance and inspection readiness, our consultancy delivers practical, compliant solutions that help teams operate with confidence.
We combine technical depth with real-world experience in NHS and commercial GMP facilities — ensuring your facility is not only compliant but efficient, sustainable, and built for long-term success.
Facility Design & Layout
We develop compliant, efficient cleanroom layouts tailored to your process, space, and future scalability.
Our designs focus on material and personnel flows, HVAC zoning, and contamination control — ensuring compliance with EU GMP Annex 1 and MHRA expectations.
Includes:
Concept and detailed layout planning
Airflow and pressure cascade mapping
Material and personnel flow analysis
Room data sheets and zoning plans
Validation & Qualification
We provide full lifecycle validation support, from drafting Validation Master Plans (VMPs) to IQ/OQ/PQ execution and summary reporting.
Our structured approach ensures traceability, regulatory alignment, and inspection readiness.
Includes:
Validation Master Plans (VMPs)
Protocols and acceptance criteria
IQ/OQ/PQ testing and reporting
Change control and requalification strategy
Our governance frameworks strengthen Quality Management Systems (QMS) and embed GMP culture across teams.
We help sites prepare for MHRA inspection through training, SOP alignment, and governance structures that sustain compliance.
Includes:
QMS setup and gap analysis
SOP suite development and document control
CAPA and deviation management
MHRA inspection readiness reviews
Quality Governance & GMP Support
Service Categories
Equipment & URS Development
We write detailed, regulator-ready User Requirement Specifications (URS) for isolators, HVAC, garments, and automation systems.
Each URS aligns technical function with GMP and VHP compatibility to give procurement teams clarity and control.
Includes:
URS authoring and approval process
Equipment tender and vendor alignment
FAT/SAT and qualification support
Data integrity and electronic batch record integration
Every facility is unique and so is our approach.
Our consultants don’t just advise on cleanroom operations we work within them.
Drawing on real, hands-on experience in GMP and aseptic manufacturing environments, we provide practical solutions that strengthen compliance and performance from the inside out.
FAQ
What is cleanroom?
A cleanroom is a highly controlled environment where temperature, humidity, and airborne particles are tightly regulated to protect products and processes. Cleanrooms are essential in aseptic manufacturing, pharmaceutical production, and other sectors that demand contamination control.
Why is validation important?
Validation ensures your cleanroom, equipment, and processes perform consistently and meet regulatory requirements such as EU GMP Annex 1. It’s the formal evidence that your systems work as intended — safeguarding both product quality and patient safety.
How do you optimize workflows?
We analyse material and personnel flows, equipment placement, and process steps to remove bottlenecks and reduce contamination risk. Our consultants bring real-world experience from operating within cleanrooms, ensuring every recommendation is practical, compliant, and achievable.
What services do you offer?
We provide a full range of cleanroom consulting services, including:
Facility design and layout planning
Validation strategy and documentation (VMP, IQ/OQ/PQ)
Quality governance and GMP support
Section 10 aseptic consultancy for NHS services
URS development for isolators, HVAC, and equipment
Who are your clients?
We work with NHS aseptic units, pharmaceutical manufacturers, and healthcare organisations across the UK. Our consultants have delivered cleanroom projects from early design through to validation and inspection readiness.
How can I contact you?
You can reach us via info@w2cleanrooms.com or through our contact form on the website. We’re happy to discuss upcoming projects, validation support, or general GMP consultancy needs.
Contact
Get in touch
info@w2cleanrooms.com
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