GMP-aligned, validation-ready — engineering for Pharma &
Life Sciences where every decision is traceable
Pharmaceutical facilities operate under the strictest engineering and documentation standards of any built environment. Cleanroom classification, HVAC air change rates, pressure cascade design, and process utility purity must all be engineered to regulatory requirements — and every decision must be documented in a form suitable for DQ, IQ, and OQ activities. TEBIN delivers integrated engineering and BIM coordination aligned to EU GMP, FDA 21 CFR, and ISO 14644 from concept through to validation support.
01 — What we design and coordinate
Engineering
where every
decision
is traceable
Pharmaceutical facilities require engineering that satisfies both technical performance requirements and regulatory documentation obligations. MEP systems must be designed to support cleanroom classifications, process utilities must meet pharmacopoeial standards, and every design decision must be documented in a form suitable for qualification activities.
TEBIN designs and coordinates engineering systems for production, laboratory, and R&D environments — from cleanroom HVAC and process utilities through to electrical distribution, BMS, and validation support documentation. Our approach ensures that engineering and qualification activities can proceed in parallel without rework.
02 — Systems we coordinate
Cleanrooms & HVAC
Process Utilities
Electrical & Controls
Safety & Compliance
03 — Cleanroom design scope by classification
GMP grade drives
every engineering decision
Cleanroom classification is not a single-discipline question. It determines the HVAC strategy, filtration approach, pressurisation logic, monitoring architecture, and documentation structure for the entire facility. TEBIN coordinates these engineering decisions across all disciplines from concept through to qualification support.
| Classification | ISO Class | EU GMP Grade | HVAC Design Approach | Monitoring Design | TEBIN Engineering Scope |
|---|---|---|---|---|---|
| Critical / Aseptic | ISO 5 | Grade A | Unidirectional airflow with FFU design and redundant supply | Continuous particle counting, temperature and humidity EMS | HVAC, pressurisation cascade, filtration strategy, EMS design |
| Background Aseptic | ISO 6–7 | Grade B | Turbulent high-ACH supply, AHU design with HEPA terminal | EMS at-rest and in-operation sampling point design | AHU design, air distribution, pressure differentials, HVAC balancing strategy |
| Controlled | ISO 7 | Grade C | High air change supply with pressure cascade to adjacent zones | EMS monitoring with alarm set-points aligned to qualification limits | MEP services coordination, airlock design, pressure cascade documentation |
| Background / Gowning | ISO 8 | Grade D | Elevated air change rate above standard HVAC, directional flow | EMS monitoring and gowning area interface design | Gowning area MEP interfaces, EMS, pressure boundary documentation |
Note — TEBIN designs the HVAC, process utilities, electrical, and BMS systems to achieve and maintain these classifications throughout facility life. Our engineering deliverables are structured to support DQ, IQ, and OQ qualification activities from the start of detailed design.
04 — BIM & digital delivery
BIM that supports
GMP qualification
In GMP environments, engineering documentation is not a post-construction deliverable — it is part of the qualification lifecycle. Our BIM methodology produces deliverables that are structured for regulatory use from the moment design begins.
Cleanroom Zone Coordination
Cleanroom zones, pressure cascades, gowning routes, and material airlocks are modelled in 3D and coordinated against structural grids, MEP supply systems, and process equipment layouts.
Process Utility Routing
WFI loops, purified water distribution, process gas runs, and clean steam lines are modelled in BIM with correct slope, deadleg control, and passivation considerations documented.
GMP-Aligned Documentation
Engineering deliverables are structured to support GMP qualification activities — P&IDs, equipment layout drawings, and utility system diagrams are coordinated between BIM model and process design.
Validation Support Packages
We produce the engineering documentation packages required for DQ, IQ, and OQ activities — isometric drawings, system descriptions, and equipment schedules derived from the coordinated BIM model.
05 — Why project teams choose us
In pharma, the cost of
rework exceeds the cost
of getting it right first time
Air quality maintained by engineering, not housekeeping alone
Zero deadlegs designed into WFI and PW systems from the start
Documentation structured for qualification before construction begins
Hazardous areas classified and designed — never assumed safe
DQ/IQ/OQ packages produced from coordinated engineering deliverables
BIM coordination that supports facility lifecycle management
Get in touch
Working on a
pharma or life
sciences project?
Share your facility type, GMP classification, key process requirements, and project stage. We will outline the engineering disciplines and BIM workflows that apply, and how we structure deliverables for qualification.
Start a conversation