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Pharmaceutical Clean Room Manufacturer for GMP & Annex 1 Compliance

Everheal is a professional Pharmaceutical Clean Room Manufacturer based in China, providing OEM cleanroom engineering solutions for global pharmaceutical brand owners, contract manufacturers, and sterile drug producers.

Founded in 2013 and located in Xiangshan, Ningbo, Everheal has grown into a trusted partner in the pharmaceutical equipment and cleanroom engineering sector. With a dedicated team of 100+ professionals across production, technology, and sales, we design, manufacture, and deliver Pharmaceutical Clean Room systems that meet the highest international regulatory and operational standards.

Beyond cleanroom construction, Everheal offers integrated solutions including purified water systems, pure steam generators, sterilization systems, filling lines, and turnkey factory layout planning. Our Pharmaceutical Clean Room solutions are engineered to support long-term GMP compliance, operational efficiency, and future regulatory upgrades.

Cleanroom Engineering And Products

A Pharmaceutical Clean Room is a controlled environment designed to limit particulate, microbial, and chemical contamination during drug manufacturing. It is a foundational requirement for aseptic manufacturing, sterile fill-finish, biologics, and vaccine production. As an experienced Pharmaceutical Clean Room Manufacturer, Everheal understands that cleanrooms are not standalone spaces—they are regulatory systems that directly affect product quality, patient safety, and inspection outcomes.

A properly designed Pharmaceutical Clean Room ensures:
  • Consistent compliance with EU GMP Annex 1
  • Stable environmental control for sensitive products
  • Reduced deviation and contamination risk
  • Smooth validation and regulatory inspections
  • Long-term operational reliability

Advanced Air Filtration & Environmental Control System

Everheal Pharmaceutical Clean Rooms are equipped with HEPA or ULPA filtration systems designed to meet ISO 14644 standards.
1. High-Efficiency HEPA / ULPA Filtration
  • 99.99% efficiency at 0.3 μm
  • Coverage for ISO Class 3 to ISO Class 8
  • Terminal-mounted HEPA for critical zones
 
2. Unidirectional Airflow Design
  • Vertical or horizontal laminar airflow
  • Velocity: 0.45 ±0.1 m/s
  • Ensures continuous particle removal from critical areas
3. Real-Time Particle Monitoring
  • Continuous monitoring of ≥0.5 μm and ≥5 μm
  • Alarm-based deviation management
  • Supports contamination control strategies (CCS)
 

Modular Pharmaceutical Clean Room Solutions

Everheal adopts modular cleanroom architecture, enabling faster installation and easier future modification.
1. Prefabricated Modular Wall Systems
Electropolished stainless steel wall panels
Surface roughness Ra ≤0.5 μm
Chemical-resistant and easy to disinfect

2. Airtight Ceiling & Lighting Systems
Flush-mounted LED lighting
Airtight seals prevent particle traps
Compatible with VHP and fumigation processes

3. Cleanroom Flooring Options
Conductive or static-dissipative epoxy
Cleanroom-grade PVC flooring
Seamless installation for contamination control

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GMP-Compliant Cleanroom Design Philosophy

 
As a compliance-driven Pharmaceutical Clean Room Manufacturer, Everheal designs cleanrooms based on inspection logic, not just construction standards.
Hygienic Design Principles
Smooth, non-shedding surfaces
Radius corners R ≥30 mm
No exposed fasteners or product traps
Sealed Interfaces & Penetrations
Fully sealed joints
Airtight service penetrations
Eliminates dust accumulation points
Full Material Traceability
DOC / DOS documentation
Material certificates and change control
Supports regulatory audits and requalification

Smart Monitoring & Digital Cleanroom Management

1. BMS Integration
24/7 monitoring of temperature, humidity, pressure, and particles
Centralized control interface

2. Data Logging & Compliance
21 CFR Part 11 compliant
Secure electronic records
Audit trails and alarm logs

3. Remote Alerts & Deviation Control
SMS and email notifications
Faster response to excursions
Reduced batch loss risk

Differentiators

1. Patented Airflow Optimization™
Improves airflow uniformity and reduces turbulence.

2. Rapid Deployment System
Shortens project timelines and minimizes production downtime.

3. Complete Qualification Package
DQ, IQ, OQ, PQ support
Documentation aligned with GMP inspections

HVAC & Environmental Parameter Control

1. Temperature & Humidity Stability
Temperature: 20–24°C ±1°C
Relative humidity: 45 ±5% RH
Designed for operator comfort and process stability

2. Pressure Cascade Management
Differential pressure: 10–15 Pa between zones
Prevents cross-contamination
Supports unidirectional personnel and material flow

3. Energy-Efficient Air Handling
EC fan technology
Optimized air change rates
Reduced lifecycle energy consumption

Key Advantages of Everheal Pharmaceutical Clean Rooms

Lower Operating Costs
  • 30% energy savings with EC fan systems
  • Optimized air change rates without compromising cleanliness
Faster Installation & Commissioning
  • Modular prefabrication
  • 30% faster commissioning compared with traditional builds
Proven Contamination Control
  • Validated cleaning and decontamination protocols
  • Supports VHP, fumigation, and disinfection cycles
Future-Proof Design
  • Ready for Annex 1 revisions
  • Easy upgrades without structural overhaul
 

How to Select the Right Pharmaceutical Clean Room Manufacturer

When choosing a Pharmaceutical Clean Room Manufacturer, consider:
1. Regulatory experience with GMP & Annex 1
2. Modular vs traditional construction approach
3. Long-term energy and maintenance costs
4. Validation and documentation capability
5. Post-installation service support
Everheal supports customers from concept design to commercial operation, ensuring long-term compliance and operational success.

Technicaal Specifications Overview

Parameter Specification
Cleanroom Class ISO 14644-1 Class 5 (Grade B)
Air Changes 40–60 ACH (adjustable)
Noise Level ≤65 dB(A)
Vibration ≤5 μm/s (VC-A)
 

Ideal Applications for Pharmaceutical Clean Rooms

1. Aseptic Manufacturing
Supports sterile drug formulation and filling operations.
 
2. Sterile Fill-Finish Lines
Critical environments for injectable and infusion products.
 
3. Biologics Production
Designed for cell culture, monoclonal antibodies, and biotech drugs.
3. Vaccine Manufacturing
Stable environmental control for sensitive biological products.
 

Frequently Asked Questions

Maintenance & Lifecycle Support

1. Predictive Filter Monitoring
AI-based HEPA life prediction
Prevents unexpected airflow failure

2. Annual Certification & Requalification
Particle count testing
Airflow visualization
Pressure integrity checks

3. Global Technical Support
24/7 multilingual assistance
Remote diagnostics and on-site service options

Request a Quote

Planning a new pharmaceutical facility or upgrading your existing cleanroom?
Contact Everheal today to discuss your process requirements, regulatory targets, and cleanroom design strategy with our engineering experts.
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E-mail: info@everhealgroup.com
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Add.: No. 5, Jinhai Avenue, Dongchen Binhai Industrial Zone, Xiangshan County, Ningbo City, Zhejiang Province
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