Why Prefabricated Modular Clean Rooms Are The Future Of Contamination Control?

Introduction

Did you know that an ISO class 1 clean room only allows 10 x 0.1 micrometer particle per cubic meter? In comparison, our typical atmosphere contains around 35,000,000 of these particles in a cubic meter. Now they are completely modular and come in a prefabricated configuration. After covid rapid contamination control protocols became a reality, and prefabricated modular clean rooms achieved the objective quickly and safely. They are in line with the global regulation, providing rapid production capabilities with agile manufacturing as required by many modern industries.

These prefabricated clean rooms are very different from traditional rooms constructed from scratch with construction material from on-site and require months for construction. Panels for prefabricated rooms are brought to the site and joined like a Lego in days or weeks. These rooms require a very short time of construction as compared to traditional methods used before. Construction data shows 50% faster project completion using prefabricated rooms, and as an added advantage, after making these rooms, you can modify the size of the rooms as your needs change.

Since we are talking about contamination-controlled clean rooms, they are provided with superior control for particles through HEPA/ULPA filtration, better pressure control, and unidirectional flow. 

Prefabricated contamination-controlled rooms are very cost-effective, faster in generating revenue, and the reusability of panels in case of modification of the facility  without a full rebuild

With all these benefits, we can see these prefabricated rooms as the future backbone of infrastructure.

Types of Modular Cleanrooms

Hard-wall Modular Cleanrooms

These rooms are made with rigid panels composed of an aluminium frame and acrylic or tempered glass. These panels are used where structural integrity and full enclosure are required. Hardwall modular is known for its support of positive or negative differential pressure that has been maintained inside with ISO 5-8 classification, with minimal air leakage in the facilities where hard wall modular cleanrooms are used.

Soft-Wall Modular Cleanrooms

ideal for creating a temporary localised clean zone in industries like automotive or food, these rooms are made with flexible anti-static curtains or vinyl strips using aluminium frames. These rooms are more cost-effective than hard walls, allowing air to pass in unidirectional (one pass flow) and easy access. These are utilised where localised high cleanliness zones of ISO 7-8 environments are required.

Hybrid and Specialised Variant

These hybrid-type rooms are provided with laminar air flow and negative pressure with controlled temperature and humidity, and environmental control features. Hybrid cleanrooms are used for aseptic processing in pharmaceutical research, where an open workstation is needed within a graded environment.

Portable Clean Booths and Modular Pods

These pods are self-contained compact units provided with integrated FFU lights and controls with unidirectional laminar air flow for high cleanliness. These are very cost-effective and quick to install in 1-3 days.

Industrial Applications of Prefabricated Modular Cleanrooms

Pharmaceuticals

Creating Super-Clean Zones

To create sterile medicine, modular clean rooms are preferred as they are made very quickly, sections are built at the factory and assembled at the site, creating Iso Class 5 -7 clean zone with unidirectional air flow, making it possible for pharmaceutical companies to meet GMP standards for particle count and microbial limits.

No Production Loss In Changing Room Size

The walls of the modular room are designed to be taken apart as needed and reassembled. This allows no production loss in case the room sizes are altered. So the alteration in the facility that requires 6 months can be completed in a few days with the use of the same walls, since modular systems are demountable and reusable.

Containment for Hazardous Apis

Modular wall rooms are provided with negative pressure, which enables safe containment for API such as hormones and potent compounds. Such facilities have a lower pressure where hazardous compounds are handled, and adjacent areas are at a higher pressure, so any airborne particle will go to the HEPA filters. Operator safety in such industries can be ensured with a dual-pressure approach.

Temperature and Humidity Control

Many drugs are sensitive to temp and humidity. Modular rooms are provided with an HVAC system with cooling coils, reheat coils, humidifiers, and dehumidifiers that will control temperature and humidity with precision, with +-2 degree centigrade tolerance and humidity within 30-60% for sterile filling. Since all the equipment is fitted in the factory, they are easy and quick to install

Scalability For Different Production Volumes

From high-volume manufacturing pharmaceutical companies to smaller companies, all can utilize modular clean rooms because they offer scalability. Multiple modular rooms are connected side by side for higher production volume companies fitted with automated filling lines, whereas if hospitals want to use these modular rooms, they can be modified according to their requirements.

Biotechnology and Medical Device Manufacturing

Cell and Gene Therapy Production Environments

A modular room can be used in cell and gene therapy production after modification to a certain extent, which includes support of an ISO5-7 environment, unidirectional flow to sweep contaminated particles, and installation of multiple air locks to prevent ingress of viable particles during critical aseptic manipulations.

Fast Assembly

Quick assembly of modular clean rooms makes it ideal for biotech. Traditional construction takes 4-6 months, which is much more than the trial phase of biotech. Biotech companies need to move from phase 1 to phase 2 in a very short time. Modular rooms can be installed in weeks, which makes them a perfect fit for the biotech timeline to enable modern companies to reach investor milestones.

Portable And Hybrid Designs

Some companies require a very small space in a clean room to perform their critical tasks. For example, a company making pacemakers requires a small space with an ISO7 zone for critical steps. In that case, these modular rooms, which are portable, can be used to provide a clean space with unidirectional air flow, but the rest of the facility is uncontrolled.

Flexible Expansion For Personalized Medicine

Modular rooms are flexible according to the needs of patients, with no modification in the actual structure. Modular clean rooms can be installed initially with two rooms and can expand with demand increase, and since there are no permanent changes in the structure, they can be expanded up to 8 or 10 rooms easily and with reduced time.

Containment For Biohazardous Materials

This can be done with the help of negative pressure provided in the modular rooms to avoid the spread of biohazardous material. These modular rooms maintain a lower pressure inside a room where hazardous material is dealt with, and the remaining area is at higher pressure. This will ensure that in case of an accident, any hazardous material will be pulled into the HEPA filter.

Medical Device Packaging

Many devices, such as syringes and catheters, require packaging that should be done in a controlled environment to reduce bioburden under ISO 7. Modular clean rooms support such practice, provided with non-porous walls and covered corners that can be cleaned with disinfectant

Healthcare

Usp <797> And <800> Compliant Compounding

Compounding pharmacies require ISO 7-8 with rapid development to meet USP <797> (sterile compounding standards) and USP <800> (hazardous drug handling requirements), which have been supported by  Modular solutions, including a chemotherapy room with ISO 7 buffer rooms and ISO 8 ante-areas.

Infection Control During Peak Demand

Modular rooms can provide an airlock and growing facility to avoid any spread of contamination during flu or a pandemic. A modular room can provide 3-stage growing rooms (1. street clothes, 2. scrub room, 3. ante-room 3. buffer room). This will ensure the hospital's sterile preparation area will remain clean.

Temporary High-Clean Zones Without Disrupting Operations

A temporary high clean zone with ISO 7can be established inside a hospital or pharmacy in a place that is not as clean as ISO 7, but this can be possible because modular rooms can be installed in a place that a facility already uses, since it requires no demolition or permanent change to a structure.

Portable Clean Booths For Critical Procedures

A clinical procedure or research inside a health care facility that requires contamination clean rooms and full installation of clean room facilities is not practical, so they can use a potable clean room, as it will provide ISO 5 control.

Enhanced Monitoring

Modular rooms come with preinstalled adjustments for particle counters, so we can track particles from 035-5.0 micrometres. It also incorporates a differential pressure sensor to ensure the pressure inside the room, and also the surrounding. All this data will be given to a monitoring system that will generate an alarm if parameters are found to have drifted by this system.

Electronics and Semiconductor Manufacturing

In a semiconductor manufacturing company, a single particle of 0.1 micrometres can destroy chips that can cost 100 dollars; in order to avoid such a big loss, high air changes per hour are required to remove any particle inside the facility. This is achieved with the use of modular clean rooms providing ISO 5-6.

Modular rooms are provided with factory-tested filters, unidirectional flow, static dissipative material, and an ionizer to minimize electrostatic discharge risks. To avoid any damage from static charge, room panels have a resistivity of 10⁶-10^9. Grounding is also done with an ionizer to ground air-borne charges. Semiconductor facilities also require rapid change in configuration that ranges from room size to particle in modular type rooms, both of which can be changed very quickly with less downtime of the factory.

Hybrid modular rooms can fit in the existing rooms of the facility more economically, 50% less cost under ISO 7 rooms as compared to ISO 5 rooms. With all these added benefits of modular rooms over conventional constructions, modular rooms are a better choice for a semiconductor. facility  

Aerospace and Defence

Since ISO 6-8 is required for precision assembly and aerodynamics, and defence is one of these industries where we need an ISO 6-8 environment. Modular rooms can be used to provide such an environment. A small particle in this industry can cause a huge loss due to a compromise on avionics and guidance systems.

Modular rooms provide flexibility to expand and relocate a facility, providing a huge advantage over conventional buildings. These modular rooms, which provide negative pressure, are suitable for these industries when sensitive coating is done.

Reusability of modular rooms is an asset because it will provide decommissioning and installing the same rooms at other projects will be easy and cost-effective, and it also eliminates material loss.

The aerospace industry has very strict quality controls with the use of modular rooms. These quality controls related to adaptability, containment, and reliability can be met.

Conclusion

Unlike traditional buildings, which cannot meet the demand of the modern regulated industry, modular clean rooms are the solution. They provide many features unlike traditional buildings. Some of the features include contamination control, combining speed, adaptability, precision, and long-term sustainability. They can reconfigure, scale, and deliver  ISO compliance.

Industry owners targeting future sustainability can consider a modular clean room to build and modify their industry with custom features according to their requirements.

If you are looking for state-of-the-art, highly customizable, and modular clean rooms, then consider Suzhou Pharma Machinery Co., Ltd. (SZ Pharma). Their products reflect 16 years of experience in the design and manufacturing of clean rooms. They offer construction of ISO 5 to ISO 8 (Class 100 to Class 100,000) clean rooms as well as Class B aseptic processing environments. Visit https://www.sz-pharma.com/  to explore all their options.