Mediclue Technology Pvt. Ltd.

Engineering&ManufacturingforCriticalEnvironments.

We manufacture, design and deliver GMP-compliant Cleanroom Equipment, Sterilization Systems and Scientific & Laboratory Solutions for Pharmaceutical, Healthcare, Biotechnology and Life Sciences industries worldwide.

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Projects

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Countries

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Years

Cleanroom
Cleanroom
CSSD
CSSD
Lab
Lab
Compliant with
ISO 9001:2015ISO 13485:2016ISO 14644-1WHO GMPCEUS FDABS EN 285ZED GoldISO 9001:2015ISO 13485:2016ISO 14644-1WHO GMPCEUS FDABS EN 285ZED Gold
Quality Assurance

Certifications & Awards

Our commitment to quality is validated by internationally recognised certifications and industry standards.

Certificate of Compliance

ZED Gold

Mediclue Technology Pvt. Ltd.

CERTIFIED

ZED Gold

Ministry of MSME, Govt. of India

Zero Defect Zero Effect — Gold rating recognising world-class product quality, zero defects and minimal environmental impact in manufacturing.

Cert No: ZED Gold Certified

Current

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Certificate of Compliance

ISO 9001:2015

Mediclue Technology Pvt. Ltd.

CERTIFIED

ISO 9001:2015

Bureau Veritas Certification

Internationally verified quality management system — every unit we ship follows a documented, audited manufacturing process.

Cert No: IN-QMS-2024-0891

Valid until Mar 2027

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Certificate of Compliance

WHO GMP

Mediclue Technology Pvt. Ltd.

CERTIFIED

WHO GMP

Drug Controller General of India

Manufacturing validated to WHO Good Manufacturing Practice guidelines for pharmaceutical-grade cleanroom and sterilization equipment.

Cert No: GMP-2024-MC-0234

Valid until Dec 2026

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Certificate of Compliance

CE Marking

Mediclue Technology Pvt. Ltd.

CERTIFIED

CE Marking

Notified Body — EU Directives

Products CE marked per EU Directives — meeting EU health, safety and environmental standards for medical and industrial equipment.

Cert No: CE-PED-2023-0567

Current

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Certificate of Compliance

ISO 14644-1:2015

Mediclue Technology Pvt. Ltd.

COMPLIANT

ISO 14644-1:2015

International Organization for Standardization

Cleanroom design and classification validated from ISO 5 (Grade A) to ISO 8 (Grade D) per ISO 14644-1 methodology.

Cert No: Design Standard

Ongoing Compliance

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Certificate of Compliance

ISO 13485:2016

Mediclue Technology Pvt. Ltd.

CERTIFIED

ISO 13485:2016

International Organization for Standardization

Quality management system specific to medical devices — ensuring our products meet the strictest regulatory requirements for medical device manufacturing.

Cert No: Medical Devices QMS

Current

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Certificate of Compliance

ISO 14001:2015

Mediclue Technology Pvt. Ltd.

CERTIFIED

ISO 14001:2015

International Organization for Standardization

Environmental management system certification — demonstrating our commitment to sustainable manufacturing with minimal environmental impact.

Cert No: Environmental Management

Current

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Certificate of Compliance

ISO 17665:2024

Mediclue Technology Pvt. Ltd.

COMPLIANT

ISO 17665:2024

International Organization for Standardization

Sterilization of health-care products — moist heat. Our autoclaves and sterilizers are designed and validated to this international standard.

Cert No: Sterilization Standard

Ongoing Compliance

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Certificate of Compliance

BS EN 285

Mediclue Technology Pvt. Ltd.

COMPLIANT

BS EN 285

European Standards Body

Large steam sterilizers designed and tested to BS EN 285 — the European standard for sterilization in healthcare and pharmaceutical environments.

Cert No: Product Standard

Current

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Certificate of Compliance

ISO 45001:2018

Mediclue Technology Pvt. Ltd.

CERTIFIED

ISO 45001:2018

International Organization for Standardization

Occupational health and safety management system — ensuring a safe working environment for all our employees and contractors.

Cert No: OHS Management

Current

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Certificate of Compliance

FDA

Mediclue Technology Pvt. Ltd.

COMPLIANT

FDA

U.S. Food and Drug Administration

Products designed to meet FDA regulatory requirements for pharmaceutical and medical device manufacturing environments.

Cert No: Regulatory Compliance

Ongoing Compliance

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Certificate of Compliance

MDD 93/42/EEC

Mediclue Technology Pvt. Ltd.

COMPLIANT

MDD 93/42/EEC

European Commission

Medical Device Directive compliance — applicable products conform to EU MDD requirements for design, manufacture and safety of medical devices.

Cert No: EU Directive

Current

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Product Categories

Engineered for regulated environments.

Advanced Cleanroom Equipment

Advanced Cleanroom Equipment

Precision-engineered cleanroom equipment designed and manufactured for controlled, contamination-sensitive environments across pharmaceutical, healthcare, biotech and critical manufacturing applications.

  • Laminar Airflow Units – HLAF / VLAF / RLAF
  • Static & Dynamic Pass Boxes
  • Air Showers
  • Sampling & Dispensing Booths
  • Biosafety Cabinets & Fume Hoods
  • HEPA Filtration Systems
Explore Cleanroom Equipment
CSSD & Sterilization Systems

CSSD & Sterilization Systems

Reliable sterilization and CSSD solutions engineered for hospitals, healthcare facilities and critical environments, with a focus on safety, efficiency and consistent performance.

  • Horizontal & Vertical Autoclaves
  • Fully Automatic Sterilizers
  • ETO Sterilizers
  • CSSD Equipment & Workstations
  • Sterilization Accessories
Explore Sterilization Systems
Scientific & Laboratory Solutions

Scientific & Laboratory Solutions

Engineered laboratory equipment and furniture solutions supporting research, testing, quality control and scientific applications across pharmaceutical, healthcare, biotech and industrial laboratories.

  • Fume Hoods & Extraction Systems
  • B.O.D. & Laboratory Incubators
  • Stability Chambers
  • Hot Air & Vacuum Ovens
  • Muffle Furnaces
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Manufacturing Excellence

Built in-house. Precision-engineered. Globally deployed.

Mediclue is a manufacturer first. Our in-house facility brings together precision fabrication, stainless steel processing, HEPA filtration engineering and cleanroom assembly under one roof — delivering consistent, validated products to regulated industries across 30+ countries.

01

In-House Manufacturing

Every product is designed and fabricated within our own facility — giving us complete control over quality, tolerances, lead times and compliance documentation from raw material to dispatch.

02

ISO & GMP Compliance Built-In

Manufacturing processes are aligned with ISO 9001, ISO 13485 and GMP requirements by design — not as an afterthought. Every unit ships with full traceability and documentation.

03

Zero-Contamination Engineering

Cleanroom equipment is engineered with cascading pressure differentials, unidirectional airflow and seamless surface finishes that eliminate contamination pathways by design.

04

Validated & Proven Products

Our products are validated through Factory Acceptance Testing (FAT), backed by IQ/OQ/PQ-ready documentation and field-proven across 200+ installations in 30+ countries.

Mediclue cleanroom installation

Project 184

Sterile manufacturing facility · ISO Class 7 · Commissioned 2025

Global Footprint

Trusted across regulated industries worldwide.

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Years of Manufacturing

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Products Installed Globally

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Countries Served

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Certifications & Standards

North AmericaEuropeMiddle EastAfricaSoutheast AsiaOceania
Explore our product range →

Our Clients

Pharmaceutical manufacturers, hospitals and research institutions across India and abroad.

Intas PharmaceuticalsPanacea BiotecSun PharmaCadila HealthcareCiplaZydus LifesciencesTorrent PharmaAlkem LaboratoriesIntas PharmaceuticalsPanacea BiotecSun PharmaCadila HealthcareCiplaZydus LifesciencesTorrent PharmaAlkem Laboratories

From the Knowledge Base

Insights on cleanroom & sterilization engineering.

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Client Voices

What our clients say.

"We have been using Mediclue's CSSD equipment for over a year now. The machines are sturdy, efficient, and easy to maintain. Overall, very good value for money."
PG

Ms. Priya Gupta

Purchase Manager, LifeCare Hospitals Group

"We recently upgraded our CSSD unit with equipment from Mediclue Technology Pvt. Ltd., and the experience was seamless. The quality of the sterilizers and trolleys is excellent."
NS

Dr. Neha Sharma

Chief Medical Officer, Sunrise Multispeciality Hospital

"Our cleanroom setup required custom sizing, and Mediclue handled it perfectly. They understood our regulatory requirements and delivered on time without compromising quality."
RM

Mr. Ravi Menon

Operations Director, BioPure Labs Pvt. Ltd.

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