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E Tech Group and Germfree Collaborate to Design Cutting Edge Modular Cleanrooms
E Tech Group and Germfree are pioneering modular cleanroom design, combining advanced automation, critical management systems, and data-driven manufacturing insights to deliver exceptional results.
Author contributors: Director of Application Engineering Vivek Puthezath and Germfree Commercial Director Stephen Ondek
An ongoing collaborative project between E Tech Group and Germfree stands at the forefront of modular cleanroom design. The partnership incorporates state-of-the-art building automation and critical management systems with advanced data aggregation capabilities for manufacturing intelligence insights to deliver remarkable results to customers.
Project Description
In early 2024, Germfree, a company specializing in the design and manufacture of modular cleanrooms, approached E Tech Group to collaborate on modernizing their building management and critical monitoring systems. The goal of the partnership was two-fold: first, to meet current regulatory standards for environmental monitoring and data integrity, specifically complying with FDA’s 21 CFR Part 11 regulations governing electronic records and electronic signatures. Additionally, Germfree wanted their cleanrooms to employ advanced data storage and aggregation technologies so clients can readily use data analytics for manufacturing intelligence initiatives to optimize their process.
Germfree’s modular cleanrooms are typically employed for specialized applications including:
- Cell and gene therapy production
- Decentralized, on-demand pharmaceutical manufacturing
- Early and preclinical stage drug manufacturing
- Biopharmaceutical research and production
- Specialized production of customized medication (hospitals and compounding pharmacies)
The modular cleanroom design incorporates several critical features required by this clientele. These include strict environmental control and monitoring capabilities to ensure the safety, efficacy, and compliance of the therapies produced. Each cleanroom can be customized to meet a client’s specific regulatory requirements including USP 795, 797, and 800 for pharmacies, biosafety levels 1 through 4, European grades B, C, and D environments for gene and cell therapies, as well as all relevant ISO standards. In addition, the cleanrooms can be customized to meet a client’s specific layout, materials, and integrated technology requirements.
Figure 1: Interior view of a Germfree cGMP compliant modular cleanroom.
The cleanrooms are designed with durability, scalability, and relocation capability in mind, including steel frames and ArcoPlast walls so that clients can easily adapt, expand, or even relocate their operation as needed. Germfree personnel manage all aspects of a cleanroom solution on behalf of their clients including design, construction, installation, commissioning, qualification, certification and maintenance. The modular cleanrooms can often be ready for use within a ten-month timeframe. Additionally, because many of Germfree’s clients are small-scale research laboratories, universities, and hospitals, the cleanrooms have been designed to be cost-competitive as budgets are often limited.
Figure 2: Germfree’s modular cleanrooms are designed for compliance with all regulatory requirements and are built with durable construction materials.
Overview of FDA’s 21 CFR Part 11 Regulation
The 21 CFR Part 11 regulation by the U.S. Food and Drug Administration (FDA) sets the standards for electronic records and electronic signatures in FDA-regulated industries. It establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. The regulation ensures that electronic systems used in manufacturing processes maintain data integrity, security, and compliance so that the production of pharmaceutical products is safe and effective.
Cutting-Edge Customized Environmental Monitoring and Control
E Tech Group’s environmental monitoring system (EMS) provides precise control, continuous monitoring, and recording of environmental conditions to meet compliance requirements. The system was designed and implemented with the following fundamental priorities:
- Full adaptability to comply with all relevant regulations and standards
- Adherence to the 21 CFR Part 11 protocol
- Full system scalability, ensuring seamless integration of any future additions to the cleanroom module
- An intuitive user interface, such that new users can operate it without significant training
- Maintaining cost-competitive pricing of the cleanroom
E Tech Group’s building management system (BMS) design fully controls all environmental equipment, including air handlers, exhaust fans, fan filter units and variable air volume (VAV) systems to maintain the desired conditions within the cleanroom. It not only provides trend data visualization for real-time system performance insights but also maintains a complete record of environmental conditions.
A CMS in Compliance with 21 CFR Part 11 and cGMP Regulations
The critical monitoring system (CMS) implemented by E Tech Group provides verification and documentation that the cleanroom conditions remain within specified limits, as required for compliance with regulatory standards and supporting quality assurance. In compliance with 21 CFR Part 11 regulations, the CMS incorporates secure login processes, electronic signature capabilities, and detailed audit trails, so that every action is traceable, securely recorded, and verifiable. This level of monitoring and record keeping is important for maintaining the integrity of critical environments where precise control over environmental parameters like temperature, absolute and differential pressure, humidity, and particle count is necessary for sensitive processes.
Additionally, the CMS monitors and records environmental conditions within relevant process equipment such as autoclaves and incubators. This provides a comprehensive record that products are manufactured and stored under the ideal conditions required by regulatory standards, including current Good Manufacturing Practice (cGMP) regulations.
Intuitive User Interface, Web Browser Accessibility
E Tech Group designed the user interface to be highly intuitive, allowing new users to operate it without significant training, while also maintaining cost-competitiveness. The interface is built using Ignition (by Inductive Automation), allowing users web browser access to easily make adjustments to temperature, pressure, humidity, and other environmental parameters.
Germfree: Expert Guidance on Regulatory Requirements for Specialized Applications
Germfree’s engineering team possesses extensive knowledge and expertise to advise clients on the regulatory requirements relevant to their particular application. Their engineers determine necessary air changes, room classifications, pressure cascades, and other specifications.
Clients can focus on their core science while relying on Germfree expertise for cleanroom design, and the cleanroom’s capabilities to maintain compliance and product integrity during production.
What is Manufacturing Intelligence?
The field of manufacturing intelligence integrates aspects of computer science, data analytics, and systems engineering to optimize manufacturing processes, and it is one of E Tech Group’s core capabilities. At a high level, its goal is to collect and aggregate data from diverse sources within the manufacturing process, including equipment performance metrics, environmental data, sensors, production lines, and product quality results into a singular platform. Advanced analytics, machine learning, and data visualization tools can then readily analyze this data, providing valuable insights that can increase productivity, optimize and predict maintenance needs, improve product quality, and reduce costs.
Digital SME: One Platform to Consolidate Data from Diverse Vendors
E Tech Group incorporated a singular data aggregation platform into the cleanroom’s design so that clients can readily employ data analytics and other manufacturing intelligence initiatives to optimize their process.
Cleanrooms typically employ different vendors’ specialized process equipment including, but not limited to spectrometers, bioreactors, and chromatographs. It is common for each piece of equipment to utilize differing communication protocols and data formats, which made full data integration a challenging endeavor.
E Tech Group collaborated with equipment vendors to standardize communication protocols, encouraging their adoption of the industry-standard OPC UA to simplify data transfer to a single data aggregation platform within the cleanroom. In addition, E Tech Group identified equipment-specific datasets that are particularly valuable for end-user analytics and collaborated with vendors to extract this needed data.
Figure 3: E Tech Group incorporated a data aggregation platform into their design, providing clients the capability of employing manufacturing intelligence initiatives to their process.
Golden Batch Analysis – The Power of Data Analytics
A powerful example illustrating the benefits of manufacturing intelligence involves golden batch analysis. When an ideal production batch (the “golden batch”) is created, all critical process parameters are trended that led to its creation. This set of parameters then serves as the gold standard for optimal production conditions of the batch.
With these parameters known, every subsequent batch in production can be monitored in real time to see how it’s trending in comparison to the golden batch parameters. Manufacturing intelligence uses data analytics and machine learning to compare real-time production data against the golden batch, identifying deviations and even suggesting real-time process parameter adjustments. The result is better product quality and consistency, reduced waste, and therefore improved efficiency.
Equipment Selection
To balance cutting edge capability with cost-effectiveness, the modular cleanroom design incorporates the following platforms:
- PLC: A Rockwell Automation PLC was selected to automate and integrate the control of all critical systems, ensuring robust operation and compliance with regulations including 21 CFR Part 11.
- User Interface: The system’s user interface was implemented using Inductive Automation’s Ignition to support the project’s budgetary goals while also providing easy accessibility via web browser.
- Historian: A Canary Labs historian was selected based on its high level of functionality and cost-effectiveness.
- Isolator (Optional Addition): The cleanroom’s isolator is integrated with AST’s (Advanced Sterilization Technologies) automated fill-finish systems for sterile manufacturing.
- Smart Hood (Optional Addition): Designed by Germfree, the smart hood incorporates label printing and weighing scales that enhance IV compounding efficiency.
Closing Remarks
At Germfree and E Tech Group, we take great pride in our contribution to therapy research, and supporting the accessibility of rare and novel drugs for those who need them most. We deeply understand the significance of this effort and have diligently worked to align our solutions with clients’ budget constraints so that vital research and treatment can continue.
The collaboration between Germfree and E Tech Group has significantly advanced modular cleanroom technology. By integrating modern building management and critical monitoring systems tailored to meet the stringent demands of the pharmaceutical and biotechnological industries, clients can be confident that the necessary conditions for producing safe and effective therapies are met.
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