How to Select A Modular Cleanroom
Cleanrooms offer a wide range of options to create the contamination-free environment needed to manufacture critical products. While it may seem overwhelming, focusing on key requirements for your specific process can help simplify the decision for a custom modular cleanroom that meets both process and regulatory standards. This guide walks through step-by-step how to select a modular cleanroom for your facility.
Define Modular Cleanroom Requirements and Regulatory Standards
Step 1: Identify Processes, Products, and Personnel Using the Cleanroom
The first consideration is to analyze the operations, products, and personnel that use the cleanroom, helping determine the cleanliness level needed, airflow patterns, and design features to ensure adequate contamination control. At this time, industry-specific considerations should also be factored into the requirements, deciding if additional regulatory standards must be met for certification, such as USP, GMP/FDA, and ISO.
Step 2: Determine Modular Cleanroom Type and Construction Needed
Based on airflow, temperature, and humidity requirements, either a recirculating or non-recirculating cleanroom will provide the required contamination control and climate regulation. While recirculating cleanrooms reuse and refilter the same air, non-recirculating cleanrooms pull in outside air. The right cleanroom construction, whether hardwall, softwall, or low-profile, should be considered depending on the facility layout and budget requirements.
Step 3: Understand Size, Layout, and Expansion Options Available
Evaluating the number of workers, equipment, and process steps occurring within the cleanroom will help determine the room size and inform consideration of future expansion or relocation options for a modular cleanroom. It is essential to include the ceiling height and building constraints in planning to ensure the cleanroom can be built to the available dimensions within the facility.
Modular Cleanroom Design and Specialty Features
Step 4: Select Accessories and Contamination Control Features
Modular cleanrooms can be outfitted with a wide range of specific solutions, including:- Air Showers
- Gowning Rooms
- Pass Throughs
- Furniture
Step 5: Define Performance Requirements for Process Compatibility
How the cleanroom performs as-built, at rest, and in operation provides testable criteria for choosing a modular cleanroom that reliably meets ISO classifications and regulatory requirements throughout its lifecycle.
- As-built performance examines the cleanroom with all systems installed and running, but without equipment or personnel to verify that the shell and filtration can achieve the necessary requirements.
- At rest has all fixed equipment installed, but no personnel or processes, to confirm that even with equipment in place, the cleanroom still meets specified cleanliness, airflow patterns, and other environmental conditions.
- Operational performance assesses the cleanroom in normal use, with people working and processes running, ensuring the modular design can maintain the required classification and compliance during operation.
Step 6: Compare Cleanroom Options and Integration Requirements
Cleanrooms with different designs and materials can be compared against the same set of requirements to evaluate which solution will physically, mechanically, and operationally fit into a facility, processes, and future planning. Another consideration is how well the cleanroom systems integrate with what is already in place or what will be added in the future. This is an opportunity to make sure the cleanroom will perform to specifications once installed, as well as to choose a solution that supports future growth.
Cleanroom Implementation and Technical Resources
Step 7: Plan Cleanroom Installation, Maintenance, and Certification
Thinking through the lifecycle of the cleanroom, this step defines how the cleanroom fits within the available space, how its systems will be serviced, and which standards apply to certify and re-certify the cleanroom when necessary. It will help determine which cleanroom offers the best overall solution, long-term operating costs, and compliance with audits and inspections without emergency redesigns or modifications.
Step 8: Reference Resources to Compare and Select the Right Cleanroom Type
To ensure your cleanroom solution meets all your requirements, reference datasheets, PDFs, and other downloadable resources to compare modular cleanroom types and their functionalities.
Contact Us for Recirculating or Non-Recirculating Flow Cleanrooms Today
To meet the needs of various industries, Clean Air Products offers a range of modular cleanroom solutions, including additional features and accessories. We can provide Class 100,000 (ISO 8) to Class 10 (ISO 4) cleanroom environments to support high-purity processes with the contamination control, airflow, and other internal systems required for demanding applications. Contact Clean Air Products to discuss your modular cleanroom project, request a quote to begin, or explore customer support for more information.
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