Views: 0 Author: Shanghai Marya R&D Team Publish Time: 2026-10-08 Origin: Site
Cleanrooms are controlled environments designed to minimize airborne particles and other sources of contamination during manufacturing, testing, and research. They are widely used in pharmaceutical production, biotechnology, medical device manufacturing, electronics, and other industries where environmental cleanliness directly affects product quality.
The main types of cleanrooms include modular, hardwall, softwall, and traditional stick-built cleanrooms. They can also be classified according to ISO cleanliness levels, GMP requirements, and their intended applications.
Understanding these differences is essential when planning a new cleanroom facility or upgrading an existing production area.
This guide explains the different types of cleanrooms, their classifications, common applications, and key factors to consider when selecting a cleanroom for pharmaceutical manufacturing.
Table of Contents
Cleanrooms can be categorized in three main ways:
By construction: Modular, hardwall, softwall, and traditional stick-built cleanrooms.
By cleanliness classification: ISO 14644-1 classes and applicable GMP cleanroom grades.
By application: Pharmaceutical, biotechnology, medical device, and electronics cleanrooms.
These categories describe different characteristics of a cleanroom rather than four or more mutually exclusive systems.
For example, a pharmaceutical cleanroom may use modular hardwall construction while meeting the required EU GMP Grade C environmental conditions.
The following table provides an overview of common cleanroom types.
Cleanroom Type | Main Features | Typical Applications |
|---|---|---|
Modular Cleanroom | Prefabricated panels and adaptable layouts | Pharmaceutical, biotechnology, medical devices |
Hardwall Cleanroom | Rigid walls and controlled environmental separation | Sterile manufacturing and controlled production |
Softwall Cleanroom | Flexible curtain enclosure with filtered air supply | Localized particle control and selected non-critical operations |
Stick-Built Cleanroom | Permanent construction integrated into a building | Large pharmaceutical facilities and complex production plants |
The correct choice depends on contamination risk, facility layout, operational requirements, project budget, and future expansion plans.
Cleanroom construction influences environmental control, installation flexibility, maintenance accessibility, and long-term operating costs.
Modular cleanrooms are assembled using prefabricated wall panels, ceiling systems, doors, and other components.
Unlike conventional construction, modular systems are designed around standardized or customized components that can simplify installation and future modifications.
Key advantages:
Flexible layouts for changing production requirements.
Potentially shorter on-site installation periods.
Easier integration of selected cleanroom equipment.
Opportunities for expansion or reconfiguration.
Smooth, cleanable surfaces when suitable materials are selected.
Modular construction is often considered for pharmaceutical production facilities, biotechnology laboratories, and medical device manufacturing.
However, installation schedules and project costs depend on room size, HVAC complexity, utility integration, qualification requirements, and site conditions.
For pharmaceutical projects, modular cleanrooms still need to meet all applicable contamination control and GMP design requirements.
Hardwall cleanrooms use rigid wall panels to create an enclosed and controlled environment.
They can incorporate air filtration systems, pressure control, personnel access systems, and cleanable interior finishes.
Hardwall construction is particularly useful where reliable environmental separation and controlled personnel or material movement are important.
Typical applications include pharmaceutical production rooms, aseptic manufacturing support areas, medical device production, and biotechnology facilities.
Hardwall systems can be constructed using modular panels or traditional building methods. Therefore, a hardwall cleanroom can also be a modular cleanroom.
Softwall cleanrooms use flexible curtains suspended from a supporting frame, often combined with fan filter units to provide localized clean air.
They are frequently selected where flexibility and relatively simple installation are important.
Potential advantages include:
Flexible enclosure configurations.
Easier relocation than many permanent cleanroom structures.
Localized particle control.
Reduced structural work for selected applications.
However, flexible curtains may make precise pressure control and environmental separation more challenging.
Softwall cleanrooms are not restricted to a single ISO class. Their achievable cleanliness depends on airflow design, filtration, enclosure conditions, surrounding environment, and verified particle measurements.
For pharmaceutical applications involving significant microbial contamination risks, more robust environmental separation may be necessary.
Stick-built cleanrooms are constructed as permanent building spaces using conventional on-site methods.
They are often selected for large or complex facilities where cleanroom layouts must be closely integrated with the building structure and utilities.
This approach can support:
Customized room dimensions.
Complex HVAC and utility installations.
Permanent production layouts.
Integration with existing industrial buildings.
However, conventional construction may involve more extensive on-site work and can be less flexible when major future layout changes are needed.
In addition to their physical construction, cleanrooms are classified according to their environmental cleanliness requirements.
Two important frameworks for pharmaceutical facilities are ISO 14644-1 and pharmaceutical GMP requirements.
ISO 14644-1 classifies air cleanliness based on the concentration of airborne particles at specified particle sizes.
The standard defines ISO Classes 1–9, with lower class numbers representing more stringent particle concentration limits.
For pharmaceutical and related manufacturing applications, ISO Classes 5, 7, and 8 are commonly discussed.
ISO Class | Maximum Particles ≥0.5 µm/m³ | Example Application |
|---|---|---|
ISO 5 | 3,520 | Critical clean air zones and selected aseptic processing applications |
ISO 6 | 35,200 | Certain controlled manufacturing and laboratory environments |
ISO 7 | 352,000 | Controlled production rooms and supporting environments |
ISO 8 | 3,520,000 | Less stringent controlled manufacturing areas |
The examples are illustrative. ISO class selection must be based on process requirements and appropriate qualification.
ISO classification evaluates airborne non-viable particles. It does not independently establish microbial contamination limits or demonstrate full pharmaceutical GMP compliance.
Official reference: ISO 14644-1:2015.
For sterile pharmaceutical manufacturing under EU GMP Annex 1, cleanrooms are classified into Grades A, B, C, and D.
Each grade corresponds to different contamination control requirements and manufacturing operations.
GMP Grade | Typical Pharmaceutical Application |
|---|---|
Grade A | Critical aseptic processing zones, including exposed sterile product filling |
Grade B | Background environment for conventional Grade A aseptic operations |
Grade C | Less critical sterile manufacturing and selected preparation activities |
Grade D | Supporting preparation and component handling operations |
Actual grade requirements depend on the manufacturing process, sterilization strategy, barrier technologies, and contamination risk assessment.
A GMP cleanroom must also incorporate suitable microbiological controls, personnel practices, environmental monitoring, and qualification procedures.
For a detailed comparison of these standards, read our guide: What Is the Difference Between ISO and GMP Cleanroom Classifications?.
Official reference: EU GMP Annex 1 – Manufacture of Sterile Medicinal Products.
Federal Standard 209E was an earlier U.S. cleanroom classification system that was cancelled in 2001 and superseded by ISO 14644 standards.
Some older engineering documents still use terms such as Class 100 or Class 10,000.
Historical FS209E Class | Common ISO Equivalent |
|---|---|
Class 100 | ISO 5 |
Class 1,000 | ISO 6 |
Class 10,000 | ISO 7 |
Class 100,000 | ISO 8 |
These comparisons are useful when reviewing historical specifications, but new projects should use the applicable current standards.
Different industries have different contamination risks, production processes, and environmental requirements.
Cleanroom design must reflect the actual manufacturing activities rather than selecting an ISO classification alone.
Pharmaceutical cleanrooms are designed to control contamination risks during drug manufacturing.
Applications may include sterile filling, pharmaceutical preparation, component handling, and selected packaging operations.
A pharmaceutical cleanroom project may require:
HVAC and HEPA filtration systems.
Suitable airflow and room pressure control.
Smooth, cleanable wall and ceiling systems.
Personnel and material airlocks.
Environmental monitoring provisions.
Integration with pharmaceutical processing equipment.
Sterile pharmaceutical facilities also require contamination control measures appropriate to the manufacturing process and applicable GMP framework.
Shanghai Marya provides Pharmaceutical Cleanroom Projects that combine engineering design, cleanroom construction, and equipment integration.
Biotechnology facilities may require controlled environments for cell culture, bioprocessing, and other sensitive operations.
The design should consider microbial contamination risks, personnel protection, process containment, material movement, and equipment compatibility.
Depending on the process, a biotechnology facility may require positive-pressure product protection, negative-pressure containment, or a combination of controlled zones.
The appropriate approach should be established through process-specific risk assessment.
Medical device cleanrooms help control contamination during manufacturing and packaging.
Their cleanliness requirements vary with the device type, manufacturing process, and product risk.
Some operations use ISO Class 7 or ISO Class 8 environments, but these are not universal requirements for all medical devices.
Material transfer, particulate generation, surface cleanliness, and product handling should be considered during facility design.
Electronics and semiconductor manufacturing may require very strict particle control because microscopic contaminants can affect sensitive components.
Some advanced processes use cleaner ISO classes than those commonly encountered in pharmaceutical production.
Although these facilities share filtration and environmental control principles with pharmaceutical cleanrooms, their contamination priorities and technical requirements can differ considerably.
Selecting a cleanroom should begin with manufacturing requirements rather than construction preferences.
The following factors are particularly important.
Determine what products will be manufactured and which operations expose products or components to contamination.
For example, conventional aseptic filling requires a different contamination control approach from many non-sterile manufacturing activities.
Select the applicable cleanliness classification and regulatory framework.
For sterile pharmaceutical processes, this may involve EU GMP Annex 1, ISO 14644 standards, and relevant local regulatory requirements.
Different zones within one facility may require different environmental classifications.
Consider whether modular, hardwall, or traditional construction best supports the production layout.
Important factors include available space, maintenance access, future expansion, utility connections, and the movement of personnel and materials.
Evaluate filtration, airflow patterns, pressure differentials, temperature, humidity, and other process-specific environmental conditions.
Cleanroom performance depends on the complete environmental control system, not simply the wall construction.
Cleanroom design should account for commissioning, qualification, environmental monitoring, cleaning, and ongoing maintenance.
Access for filter testing, equipment servicing, and monitoring activities should be considered before construction begins.
A pharmaceutical cleanroom is an integrated system consisting of the facility structure, environmental controls, and supporting equipment.
Cleanroom surfaces should be designed to minimize particle generation and facilitate effective cleaning.
Appropriate materials should be selected for durability, cleanability, and compatibility with the intended cleaning and disinfection agents.
Marya offers Cleanroom Materials for controlled environment projects.
HVAC and filtration systems help maintain the required airborne particle cleanliness and environmental conditions.
Their design should be based on process loads, personnel occupancy, room configuration, contamination risks, and qualification requirements.
Personnel airlocks, material transfer systems, and other access controls help minimize contamination between adjacent production areas.
Explore Marya's Cleanroom Equipment for supporting controlled production environments.
Certain pharmaceutical operations benefit from barrier technologies that separate critical processes from direct operator exposure.
For example, Sterile Isolators may be incorporated into aseptic manufacturing systems where appropriate.
Their use must be supported by suitable design, qualification, operating procedures, and contamination control measures.
Selecting the right cleanroom involves more than choosing a wall system or ISO classification.
A successful pharmaceutical cleanroom project must integrate facility design, HVAC, production equipment, contamination control, and qualification considerations.
Shanghai Marya provides Cleanroom Solutions for pharmaceutical production requirements.
Our services include cleanroom project planning, engineering design, equipment integration, installation support, and related technical services.
Whether you are developing a new pharmaceutical plant or upgrading an existing cleanroom, our team can help evaluate suitable configurations based on your production process and facility requirements.
Contact Marya to discuss your cleanroom project and explore a suitable engineering solution.
Common construction types include modular, hardwall, softwall, and traditional stick-built cleanrooms. These categories can overlap because modular systems may also use rigid hardwall panels.
Hardwall cleanrooms use rigid enclosures that generally provide better environmental separation and support more controlled pressure conditions. Softwall cleanrooms use flexible curtains and are often selected for localized particle control or adaptable installations.
Pharmaceutical facilities frequently use enclosed, cleanable hardwall or modular cleanroom systems. The appropriate design depends on the manufacturing process, GMP requirements, contamination risks, and equipment layout.
Yes. Modular cleanroom construction can be used in GMP-controlled facilities when its design, materials, environmental performance, qualification, and operating procedures meet the applicable requirements.
No. Cleanroom types typically describe construction or application, while ISO classes specify airborne particle cleanliness. A modular cleanroom, for example, may be designed and qualified to different ISO classifications.
At the ≥0.5 µm particle size, ISO 5 permits up to 3,520 particles/m³, while ISO 7 permits up to 352,000 particles/m³. The appropriate classification depends on the process and applicable requirements.
Costs depend on floor area, construction method, required cleanliness grade, HVAC complexity, equipment integration, automation, and qualification requirements. A project-specific assessment is necessary for reliable budgeting.
Cleanrooms can be classified by construction, cleanliness level, and application. Modular, hardwall, softwall, and traditional cleanrooms offer different advantages, while ISO and GMP classifications establish environmental requirements.
For pharmaceutical manufacturing, the most suitable cleanroom is not necessarily the one with the highest cleanliness class. It is the system that provides appropriate contamination control for the intended production process.
By considering construction, airflow, equipment integration, and GMP requirements together, manufacturers can develop cleanrooms that support product quality and efficient production.
Explore Marya's Cleanroom Projects to learn more about controlled environment solutions for pharmaceutical manufacturing.
