ISO 7 Modular Cleanroom for Pharmaceutical Packaging

Pharmaceutical packaging operations require controlled cleanliness, stable temperature and humidity, contamination prevention, and flexible production layouts.

For a pharmaceutical packaging facility in the USA, Airkey designed and manufactured an 88㎡ ISO Class 7 modular cleanroom using the Wave Series softwall configuration. The system was installed inside an existing clean workshop, allowing the customer to create a higher-grade controlled environment without major factory renovation.

Project Overview

Pharmaceutical Packaging Applications

Pharmaceutical packaging can involve aseptic filling, solid and injectable drug packaging, API handling, and other contamination-sensitive processes.

These operations require:

• Strict contamination control
• Stable temperature and humidity
• GMP-oriented production environments
• Flexible production layouts
• Controlled material transfer

Airkey's prefabricated modular cleanroom systems are designed to cover ISO Class 5–8 pharmaceutical packaging applications.

Engineering Challenges

Installing a Higher-Grade Clean Area Inside an Existing Workshop

The customer needed to add an ISO 7 controlled area inside an existing clean workshop.

The solution therefore needed to provide high-grade packaging conditions without requiring major renovation of the existing facility.

Flexible Packaging Operations

Pharmaceutical production often involves product iteration, capacity expansion, and line relocation.

A fixed masonry cleanroom can make these changes difficult and disruptive.

Contamination and Pressure Control

The cleanroom needed to prevent dirty-air backflow and cross-contamination between different packaging zones.

Airkey Engineering Solution

Transparent Softwall Cleanroom Structure

The project uses full-transparent soft curtain walls supported by aluminum frames.

The transparent enclosure allows operators to monitor equipment and production activities in real time while maintaining the controlled cleanroom environment.

Motorized Soft Curtain Doors

The cleanroom is equipped with automatic motorized soft curtain doors.

The contact-free operation reduces manual touch points and helps lower cross-contamination risks.

The large opening also allows pharmaceutical packaging materials to pass through efficiently while supporting GMP-oriented aseptic handling.

Zoned Cleanroom Control

The system uses zoned airflow and pressure management to prevent dirty-air backflow and reduce cross-contamination between sterile packaging areas.

This approach is particularly useful for pharmaceutical packaging facilities requiring different controlled zones.

Integrated FFU and Climate Control

Airkey can integrate independent zoned temperature and humidity control with FFU recirculation systems.

This allows environmental conditions to be targeted according to different pharmaceutical packaging zones without requiring major factory renovation.

Intelligent Monitoring System

An integrated touch-panel control system allows operators to adjust:

• FFU speed
• Airflow
• Zoned lighting

Operational data is traceable, helping support GMP audit requirements and simplify daily maintenance.

Easy-Clean Pharmaceutical Structure

The cleanroom uses seamless sandwich panels and curved corners.

This design minimizes cleaning dead spots and supports repeated disinfection.

The zoned layout with pressure differential helps prevent dirty-air backflow and cross-contamination during sterile packaging operations.

Modular Design for Expansion and Relocation

Pharmaceutical production frequently requires capacity expansion, product iteration, and production-line relocation.

Unlike fixed masonry cleanrooms that may require demolition and production shutdowns, Airkey's block-assembled modular system can be repositioned, expanded, and upgraded according to changing production requirements.

For customers looking for a flexible pharmaceutical cleanroom system, Airkey provides customized modular configurations based on cleanliness classification, workflow, equipment layout, and site conditions.

Explore the Airkey modular cleanroom system:
Custom Modular Cleanroom System

Factory Verification and Compliance

After custom engineering and factory prefabrication, the modular cleanroom was fully built and tested at the Airkey factory.

The system passed performance testing and received full client acceptance following product inspection.

The project documentation also states that Airkey's pharmaceutical modular systems can undergo FAT testing, ISO 14644 third-party testing, GMP validation, and supporting validation documentation for global regulatory audits.

Engineering Highlights

• ISO Class 7 pharmaceutical packaging cleanroom
• 88㎡ modular cleanroom
• Wave Series softwall structure
• Transparent soft curtain walls
• Motorized soft curtain doors
• Large material transfer opening
• Zoned airflow and pressure control
• Integrated temperature and humidity control
• FFU recirculation system
• Intelligent touch-panel monitoring
• GMP-oriented operational data traceability
• Seamless easy-clean sandwich panels
• Flexible repositioning and expansion
• Factory-prefabricated construction
• Factory performance verification

Why Choose Airkey as Your Pharmaceutical Cleanroom Manufacturer?

Airkey designs and manufactures modular cleanroom systems for pharmaceutical packaging, aseptic production, API handling, medical devices, biotechnology, and other contamination-sensitive applications.

Our systems can be customized for ISO Class 5–8 environments, with flexible layouts, controlled airflow, environmental management, and factory testing.

Explore Airkey's modular cleanroom solutions:
Modular Cleanroom Solutions

Project Outcome

The completed ISO 7 softwall modular cleanroom provides a controlled pharmaceutical packaging environment inside the customer's existing workshop in the USA.

The combination of transparent softwall construction, motorized doors, zoned environmental control, intelligent monitoring, and modular flexibility allows the customer to achieve a higher-grade packaging environment while retaining the ability to adapt the cleanroom to future production changes.

FAQ

What cleanroom classification is used for this pharmaceutical packaging project?

The project uses an ISO Class 7 modular cleanroom covering 88㎡.

Can a modular cleanroom be installed inside an existing workshop?

Yes. This project was specifically designed to install an ISO 7 modular unit inside an existing clean workshop without major factory renovation.

What is the advantage of a softwall pharmaceutical cleanroom?

The transparent softwall configuration allows real-time equipment visibility, while motorized soft curtain doors facilitate large material transfers and reduce manual contact.

Can the pharmaceutical cleanroom be expanded later?

Yes. The modular system can be repositioned, expanded, and upgraded according to changing pharmaceutical production requirements.

Can the system support GMP validation?

The project documentation states that Airkey's pharmaceutical modular systems can undergo FAT testing, ISO 14644 third-party testing, GMP validation, and supporting validation documentation.