BOTHX Modular Cleanroom Partnership and Lifecycle Support

— From Turnkey Delivery to Long-Term Service and Expansion

BOTHX Modular Cleanroom Partnership and Lifecycle Support

— From Turnkey Delivery to Long-Term Service and Expansion

Ⅰ. Why Choose BOTHX’s Integrated Turnkey Delivery Model?

In pharmaceutical and biopharma projects, what clients worry about most is not whether the technology works, but how to coordinate all stages — design, manufacturing, installation, qualification, operation, and maintenance.

BOTHX provides a fully integrated Turnkey Project Model, covering the entire lifecycle from concept to delivery and beyond. This ensures every client receives consistent technical and service support throughout both the construction and operational phases.

Ⅱ. Comprehensive Service Coverage: From Concept to GMP Operation

Our service system covers the full modular cleanroom project lifecycle:

Phase	Service Scope	Description
1. Concept Design	Provide layout planning, equipment and facility selection, and budget recommendations based on URS and process flow.	Completed within 5–7 working days
2. Module Manufacturing	Standardized module production, integrating HVAC, electrical (ELEC), building utilities (BU), clean utilities (CU), architectural (ARCH), mechanical (MECH), control (CTRL), CCTV, and pre-validation testing.	All modules undergo full factory testing
3. On-Site Installation	Module hoisting, assembly, and interface connection, completing SAT installation and testing.	Complete standard installation within 2–3 weeks, including individual equipment power-on testing.
4. Qualification & Handover	IQ/OQ documentation and testing per FDA/EU GMP requirements	Includes IQ/OQ validation reports and compliance documentation
5. Training & Start-up	On-site operator training, GMP compliance guidance, and maintenance manuals	Ensures smooth system operation by client team

Each project is jointly managed by a Project Manager (PM) and a Validation Engineer, ensuring strict control over schedule, quality, and compliance.

Ⅲ. Technical Support and After-Sales Service

BOTHX provides full lifecycle technical support across its global service network to ensure stable operation and maximum uptime.

Support coverage includes:

Routine maintenance and requalification: HEPA replacement, differential pressure re-validation, and system calibration
Remote monitoring and diagnostics: EMS/BMS integration for data trending and early fault detection
Spare parts and consumables supply: Original components and rapid delivery channels
24/7 global technical assistance: Direct engineering support whenever needed

Our goal is not just to deliver a project—but to be your long-term technology partner.

Ⅳ. Flexibility for Future Expansion and Upgrades

As production needs evolve, modular systems provide significant strategic advantages.
BOTHX designs each cleanroom with scalability and adaptability in mind from day one.

Standardized interfaces and dimensions for seamless future module addition
Independent HVAC and electrical systems allowing new modules to integrate without major renovation
Fast expansion timelines:

For areas up to 800 m², design-to-installation is typically completed within 4 weeks.
For areas between 800–2,000 m², the typical design-to-installation timeline is 6–8 weeks.
For areas between 2,000–8,000 m², the typical design-to-installation timeline is 8–12 weeks.

Customized requirements may affect the schedule and require additional timeline assessment.

Validation compatibility: New modules can leverage existing IQ/OQ/PQ documentation

Your facility can grow with your business — with minimal downtime and predictable validation.

Ⅴ. Long-Term Partnership Value: Beyond a Single Project

A modular cleanroom is more than just a physical space — it’s a long-term operational asset. Through Service and Support Agreements, BOTHX provides clients with continuous system reliability, compliance management, and performance optimization. Long-term partnership benefits include: