In today’s competitive landscape, bringing a regulated product to market requires speed, precision, and unwavering compliance. For operations managers, QA directors, and procurement teams in the pharmaceutical, medical device, and semiconductor industries, the integrity of the manufacturing environment is non-negotiable. [Your Company Name] specializes in the design, engineering, and installation of large-scale modular cleanrooms (200m² and larger), providing a predictable, scalable, and compliant solution to accelerate your production goals.
From Concept to Compliance: Turnkey Cleanroom Solutions Starting at 200m²
Traditional cleanroom construction is often slow, disruptive, and prone to budget overruns. Our modular, system-engineered approach fundamentally changes this dynamic. By prefabricating components in a controlled factory setting, we minimize on-site disruption, dramatically shorten project timelines, and ensure consistent quality. This methodology allows you to get your critical operations online faster, generating revenue sooner while meeting the strictest regulatory standards.
Tailored Cleanroom Environments for Demanding Industries
We understand that a cleanroom is not a one-size-fits-all product. It is a critical piece of process equipment. Our engineering expertise ensures your environment is precisely configured to meet the specific demands of your application.
Pharmaceutical & Biologics For sterile compounding, cell and gene therapy, and API manufacturing, our cleanrooms are designed to meet stringent EU GMP Annex 1 and FDA cGMP requirements. We focus on non-porous, easily sanitized surfaces, precise pressure cascades for contamination control, and integrated monitoring systems for viable and non-viable particulates.
Medical Device Manufacturing From Class I to Class III devices, ensuring a particle-free environment during assembly and packaging is paramount. We engineer ISO 7 and ISO 8 environments that protect sensitive components from contamination, helping you meet ISO 13485 quality management system requirements and secure necessary CE marking or FDA approvals.
Semiconductor & Electronics Fabrication The smallest airborne particle can cause catastrophic failure in wafer fabs and microelectronics assembly. Our solutions provide ISO 5 and cleaner environments with ULPA filtration, robust electrostatic discharge (ESD) flooring, and precise temperature and humidity control to maximize your product yields.
Cosmetics & Nutraceuticals Protecting product integrity and consumer safety requires a clean, controlled environment to prevent microbial contamination. Our cleanrooms help brands comply with ISO 22716 (Cosmetics GMP) and other regional hygiene regulations, ensuring product quality from formulation to packaging.
Food & Beverage Production For extended shelf-life products and high-care processing areas, controlling airborne contaminants is key to preventing spoilage. We design food-grade clean zones that meet HACCP principles and GFSI-benchmarked standards, using stainless steel components and wash-down compatible systems.
The Core Benefits of Our Modular System Engineering
- Speed to Market: Reduce construction timelines by up to 50% compared to conventional builds.
- Scalability & Flexibility: Easily expand, reconfigure, or relocate your cleanroom as your production needs evolve.
- Cost Predictability: A fixed-price model eliminates the risk of unexpected costs and project delays.
- Superior Quality Control: Factory-built modules ensure higher precision and quality than on-site construction can achieve.
Technical Specifications: What Our Clients Demand
- Structure: Heavy-duty steel superstructures, non-shedding wall panels (uPVC, GRP, HPL), chemically resistant finishes.
- Filtration: HEPA (99.99% @ 0.3µm) and ULPA (99.999% @ 0.12µm) fan filter units (FFUs) for ISO 5 through ISO 8 classifications.
- HVAC & MEP Integration: Pre-engineered air handling units (AHUs), ducting, and utility integration for precise control of temperature, humidity, and air change rates per hour (ACPH).
- Pressure Differentials: Robust systems to maintain positive or negative pressure cascades between zones to prevent cross-contamination.
- Flooring: options for seamless, coved vinyl, epoxy resin, or anti-static ESD flooring.
- Installation: In-house, certified installation teams ensure rapid assembly and system startup.
Navigating Global Compliance Standards With Confidence
Our systems are designed to satisfy or exceed international and regional standards. We provide comprehensive documentation packages to support your validation process, including IQ/OQ protocols. We have extensive experience with:
- ISO 14644-1: Classification of air cleanliness by particle concentration.
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products.
- FDA cGMP (21 CFR Parts 210, 211, 820): Good Manufacturing Practices for pharmaceuticals and medical devices.
- CE Directives: Compliance for equipment sold within the European Economic Area.
Localization Notes:
- For US Market: We emphasize our experience with FDA cGMP requirements and providing documentation for FDA audits and 510(k) or PMA submissions.
- For European Market: We highlight our expertise in EU GMP Annex 1 revisions, CE marking for integrated machinery, and adherence to EN 1822 for filter testing.
Our Process: A Seamless Path to a Validated Environment
- Consultation & URS Review: We work with you to define your User Requirement Specification.
- Detailed Engineering Design: We create full 3D models and schematics for your approval.
- Controlled Prefabrication: Modules are built and pre-tested at our manufacturing facility.
- On-Site Installation & Integration: Our expert teams assemble and commission the system with minimal disruption.
- Validation & Handover: We provide full documentation and support for your final validation (IQ/OQ).
Frequently Asked Questions (FAQ)
- What is the typical timeline for a 500m² modular cleanroom installation?
- Answer: From final design approval, a typical 500m² modular system can be installed and commissioned in 8-12 weeks, significantly faster than traditional construction.
- Can your modular systems achieve ISO 5 (Class 100) classification?
- Answer: Yes. Our systems are engineered with high-efficiency ULPA filtration and precise airflow design to reliably achieve ISO 5 and even stricter classifications for demanding applications like semiconductor fabrication.
- Do you provide support for validation (IQ/OQ/PQ)?
- Answer: We provide a comprehensive turnover package with all necessary documentation to support your Installation Qualification (IQ) and Operational Qualification (OQ). We can also assist your team in developing the Performance Qualification (PQ) protocols.
- Are your cleanrooms easily expandable in the future?
- Answer: Absolutely. Scalability is a core benefit of our modular design. Walls can be removed and new modules can be added with minimal disruption to your existing operations.
- What regions do you serve?
- Answer: We are a global provider with extensive project experience across North America, Europe, the Middle East, and Southeast Asia, ensuring compliance with local and international standards.
Post time: Oct-24-2025