Do you support international projects and overseas installation?

Yes. We support global shipping, remote technical guidance, and on-site installation supervision for overseas projects.

What certifications does your company have?

We are certified with CE, ISO, UL, and other international standards to meet global compliance and audit requirements.

Can your cleanroom pass third-party validation and audits?

Yes. Our cleanrooms support third-party testing and validation, including airflow, particle count, pressure, and environmental performance.

How much does a cleanroom cost and how can we get a quotation?

Cleanroom cost depends on class, size, configuration, and local requirements. We provide free design consultation and detailed quotation based on your project details.

Medical Device Modular Cleanroom with ISO 14644 Compliance

Name: Medical Device Modular Cleanroom with ISO 14644 Compliance
Brand: Kunshan Dersion Environmental Technology Co., Ltd
SKU: 2297813065

Jiangsu, ChinaKunshan Dersion Environmental Technology Co., Ltd

US$176.00-335.00

20 Square Meters

Product specifications

Area

Cleanliness

Product profile

Customization

Available

After-sales Service

Online Services

Warranty

3 Years

Model NO.

Customizable

Clean Type

Manual

Usage

Pharmaceutical,Food Industry, Laboratory,Biological Pharmaceuticals

Principle

Electronic Cleaning

Fuel

Electric

Certification

CE, UR, ISO

Control

PLC

Automation

Automatic

Condition

New

Customized

Cleanroom Standard

ISO 5 / ISO 6 / ISO 7 / ISO 8 / GMP

Structure

Modular Knock-Down Structure

Installation

on-Site Installation / DIY Assembly

Cleanroom Size

Customized

Reusable

Yes

Expandable

Yes

Service

Design + Manufacturing + Installation

Transport Package

Wooden Case

Specification

Customized Size

Trademark

DERSION

Origin

Jiangsu

Key features

Modular Cleanroom System: Pioneered in 2014, combining structural modularity with smart control and energy-saving design.

Fast Installation Time: Typically takes 2-6 weeks due to modular system, significantly shorter than traditional construction.

Global Compliance Standards: Fully compliant with ISO 14644, GMP, FDA, and EU GMP requirements for international projects.

Extensive Patent Portfolio: Holds over 50 national patents and operates under ISO 9001:2015 certified by SGS.

Customized Design Support: In-house engineering team provides customized layout and HVAC design based on process flow.

Flexible Expansion Capability: Modular structure allows for easy expansion, relocation, or upgrading to reduce future risks.

Proven Global Track Record: Successfully implemented in over 300 enterprises and exported to 30+ countries since 2005.

Comprehensive After-Sales Service: Includes online services, 3-year warranty, and overseas installation supervision support.

Company profile

Experienced TeamCustomization from Designs3D Software DesignR&D Capabilities

Kunshan Dersion Environmental Technology Co., Ltd

Jiangsu, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Designs CertifiedExport Year: 14 years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤7.15h

About Our Factory & Business Background

AddressSuzhou, Jiangsu, China

Plant Area19716 square meters

Number of Employees100

Terms of PaymentLC, T/T, D/P, PayPal, Western Union, Small-amount payment

International Commercial Terms(Incoterms)FOB, CIF, CFR, EXW

Average Lead TimePeak Season Lead Time: 1-3 months Off Season Lead Time: one month

Supply Chain Partners10

Our Production Capability & Technical Expertise

Main ProductsModular Cleanroom, Air Shower, Clean Room Engineering

Production Lines5

Production MachinesBending Machine, CNC Punching Machine, Dispensing Machine, Injection Machine, Laser Cutting Machine, Welding Machine

QA/QC inspectors10 people

Inspection Type for Finished Products100% inspection(Visual inspection & Function inspection)

Inspection Method for Finished ProductsFinished product checked by packing staff

R&D Engineers13 people

Traceability of Raw MaterialsYes

Our Industry Experience & Global Business Record

Main MarketsNorth America, Europe, Southeast Asia/ Mideast, Africa, Australia

Number of Foreign Trading Staff5

Overseas Agent/BranchYes

New Products Launched in Last yearNo

Product Q&A

Q:What cleanroom classes do you provide?

We offer cleanrooms from ISO Class 5 to Class 8, including GMP A/B/C/D, tailored to pharmaceutical, medical, and industrial applications.

Q:Are your cleanrooms compliant with GMP, FDA, and ISO standards?

Yes. Our cleanroom solutions are designed in full compliance with ISO 14644, GMP, FDA, and EU GMP requirements.

Q:Can you provide customized cleanroom design based on our process?

Absolutely. Our in-house engineering team provides customized layout and HVAC design based on your process flow, equipment, and capacity needs.

Q:Can the cleanroom be expanded or modified in the future?

Yes. Our modular structure allows for easy expansion, relocation, or upgrading, reducing future investment risks.

Q:How do you control temperature, humidity, and air cleanliness?

We use a professionally engineered HVAC system with HEPA filtration, ensuring stable control of temperature, humidity, pressure, and cleanliness levels.