Softwall Modular Cleanrooms

Terra manufactures five distinct cleanroom designs. Each design is ideal for different user requirements, based on ISO rating and environmental controls, for medical device, semiconductor, defense, pharmaceutical, biotechnology, and aerospace applications. As a pioneer in the critical environment industry, Terra Universal has developed and manufactured innovative solutions for over 45 years. Combining high-throughput, automated fabrication equipment with a robust, active stock of raw material, Terra is capable of producing cleanrooms of any design, size, scope and complexity at industry-leading build times. In the past 6 years, we have installed 2,132 cleanrooms, based on Terra’s scope, in active operation across the globe.

Cleanrooms for Product Testing and Packaging

Cleanrooms designed to house product quality control testing and packaging operations must adhere to the ASTM standards.  The American Society for Testing and Materials (ASTM) is a professional organization that develops standards for a wide range of industries, including durable medical equipment, health care consumables, and drug packaging.  The ASTM has developed a set of cleanroom standards that are widely used in these industries to ensure that cleanrooms meet the required level of cleanliness and safety. Some of the key ASTM cleanroom standards include:

1. ASTM F2096-11: Provides a test method for detecting leaks in flexible packaging used for sterile products.
2. ASTM F1215-89 (2014): Defines a test method for determining the efficiency of surgical gowns, drapes, and clean air suits in preventing the penetration of liquid and particulate materials.
3. ASTM F1980-07 (2011): Publishes guidelines for accelerated aging of sterile barrier systems used in medical device packaging.
4. ASTM F2942-13: Provides guidelines for designing and evaluating cleanrooms used for aseptic processing and packaging of pharmaceutical products.

ASTM-rated cleanrooms must include the following features to ensure that product testing and packaging operations are performed in a contaminant-free environment.

1. Air Filtration: ASTM-rated cleanrooms use HEPA filters to remove airborne particles from air entering the cleanroom.  ASTM-compliant spaces are designed to protect the products, or components, from cross-contamination, rather than protecting the operators or outside environment from exposure to harmful agents.
2. Positive Pressure: ASTM-rated cleanrooms maintain positive air pressure differentials between the cleanroom environment and adjacent spaces, protecting the cleanroom from an influx of contaminants.
3. Mobility: Cleanrooms equipped with heavy-duty, ISO-rated casters allow for easy room repositioning.
4. Flexible Curtains: ASTM-rated cleanrooms utilize flexible curtains, made of PVC, to support easy transfer of product and quick entry, and exit, of personnel.
5. Laminar Air Flow: As most ASTM-rated cleanrooms do not feature hard barriers for full isolation from adjacent spaces, air flow must be uniform and unidirectional to prevent contamination influx.

Terra’s ASTM-Rated Design for Product Testing and Packaging: Softwall Modular Cleanrooms

Terra’s ASTM-rated modular softwall cleanrooms feature a simplified powder-coated steel support frame consisting of reinforced vertical posts.  Wall panel strip curtains made of vinyl or static-dissipative PVC insulate the softwall environment and can be easily detached to transport equipment into the cleanroom.  Ceiling mounted, HEPA-filtered fan units and LED lighting ensure the softwall area maintain ISO class 7 requirements.  Optional upgrades include stainless steel swivel casters, germicidal UV lighting, low-energy filter fan units, static ionizers, and handheld particle counters.

Learn More: Softwall Modular Cleanrooms

Terra’s Manufacturing Capabilities

Terra builds and installs over 500 cleanrooms per year, on average. All cleanroom components are pre-engineered, quality control tested, and stocked for quick integration and assembly. In addition to product manufacturing, Terra offers a wide range of value-add services, including white glove delivery, cleanroom installation, structural seismic analysis, expedited production, qualification documentation and extended warranties. Order-specific certificates of compliance, listing each product’s adherence to ISO, UL, OSHA and seismic standards, are supplied with every qualifying sale. The leader in critical environment solutions, Terra also manufactures laminar flow hoods, desiccator cabinets, glove box isolators, pass through chambers, and a broad array of cleanroom-compliant furniture, storage and gowning equipment. To determine the appropriate ISO rating, room design and configuration for your project; please call 714-578-6100 to consult with a Terra cleanroom professional.