Terra Universal specifically designs environments and furnishings to meet the needs of aseptic operations that must conform to strict FDA, cGMP and other standards involving potential microbial contamination. Bio-pharmaceutical applications require this level of sterile environment for successful disease research and drug development. We call this special line of products BioSafe®. What makes Terra’s BioSafe® solutions clean enough for sterile operations? The answer hinges on high-grade materials and easy-clean designs.
BioSafe® Cleanroom Materials
Smooth stainless steel (SS) construction (304 or 316 grade) is standard for many BioSafe® cleanrooms and other enclosures. These products also incorporate all-stainless steel hardware. Chrome-plated fixtures, unlike stainless steel, are subject to flaking and deterioration from metal-on-metal action, and can eventually rust if exposed areas contact moisture. Plastic fixtures are less durable than steel and can also shed particles as a result of repeated use.
Electropolishing stainless steel advances metallic quality by removing impurities found on its surface, such as free iron, carbon and silica. Electropolished surfaces are cleaner and noticeably smoother than untreated stainless steel, as they lack the pits and burrs that lead to particle sloughing on standard steel surfaces.
The BioSafe® line, however, is not restricted to stainless steel. Powder-coated steel clean room paneling is available as a more economical option to stainless steel. And clean room furnishings like parts/supplies dispensers and waste receptacles maintain high BioSafe® cleanliness standards and chemical resistance when manufactured with polypropylene.
Fiberglass-reinforce plastic (FRP) and chlorinated polyvinyl chloride (C-PVC) clean rooms also create a contamination-free processing environment. These thermoplastics are non-contaminating and available in FM-certified (Factory Mutual) fire-safe formulations. Better yet, they’re just as easy to keep clean as stainless steel. Surface seals prevent particle shedding, outgassing and microbial growth.
BioSafe® glove boxes, pass-throughs, and pharmaceutical clean rooms that require internal visibility are equipped with tempered safety glass or polycarbonate viewing windows. Glass windows provide an effective moisture-barrier, and are ideal for applications requiring a range of chemical and temperature resistance. Polycarbonate provides an economical solution, yet still providing optimal visibility, chemical resistance, and static dissipation.
All of these BioSafe® materials stand up to frequent wipe-down with common biocides, including standard alcohol formulations. This chemical resistance makes them suitable for the most rigorous sterilization protocol.
BioSafe® Cleanroom Design
BioSafe® products include everything from waste receptacles to clean rooms. Each design embodies its own key features to optimize aseptic functionality.
- Clean Welds & Rounded Corners
A no-weld design with radius corners makes BioSafe® products, such as pass-through chambers, free of cracks and crevices where germs and other contaminants rest. Clean room furnishings, like Terra’s BioSafe® Non-Folding Step Ladder, use only clean, continuous-seam welds. BioSafe® Glove Dispensers minimize the need for welds by incorporating cut-out openings that make all surfaces accessible to a cleaning wiper and minimize the chance of particle build-ups. BioSafe® Glove Boxes include radius corners, a sloped bottom and drain valve, allowing convenient disinfectant wash downs.
- Double-Wall Composition
Capable of fulfilling the highest ISO standards and complying with seismic code, cleanrooms can be composed of interlocking double-wall stainless steel panels. In addition to providing insulation, a double-wall structure allows recessed plumbing and electrical utilities to ensure smooth internal surfaces. To minimize the demand placed on particle filters, recirculating designs with plenums and duct-work are available.
Similar to the clean rooms, BioSafe® Pass-Throughs feature a double-wall design, isolating door interlock hardware and providing rigidity to the structure. The automatic interlock system is located in between the walls, so there are no horizontal surfaces within the chamber where germs and other contaminants can gather.
- Flush Mounting
BioSafe® designs ensure flush mounting of mirrors, pass-throughs, and dispensers that will not collect particles or disrupt laminar airflow. Cleanroom mirrors are firmly applied to walls, leaving no room for hard-to-clean crevices. Low-profile, seamless pass-through frames are installed as if they are a smooth continuous extension of the wall. Troublesome dust is kept out of dispensers, safety glass holders and waste receptacles by covering all wall-flushed mounting slots.
- Clean Hinges & Removable Components
Additional protection from particle build-up is implemented by the clean hinge design found on BioSafe® dispensers and waste receptacles. Terra avoids using “piano” hinges with multiple crevices that are impossible to clean. Instead, we use a simple, efficient hinge design that is easy to wipe down. The receptacles’ removable bottom allows easy access for cleaning of the interior. And, because of its soft-close lid mechanism, disposal of waste is both quiet and non-turbulent. Similarly, components like BioSafe® pass-through chamber doors can be removed for easy cleaning and steam sterilization.
- Sloped Tops
Accumulated dust on horizontal surfaces can certainly pose a threat to the cleanliness rating of your lab or clean room and be hard to reach when cleaning. The sloped tops of BioSafe® dispensers assist in minimizing this inconvenience, without creating turbulence by disturbing laminar air flow.
- Cut-Away Seams & Slotted Surfaces
Standard square corners with closed seams permit unwanted particle build-up that is difficult to clear out. To avoid this problem, BioSafe® dispensers have a thin cut-away seam, providing an opening through which particles and air can move. BioSafe® step ladders and clean room benches similarly include slotted or perforated horizontal surfaces, which promote cleanliness and laminar air flow.
Terra’s BioSafe® cleanrooms and cleanroom equipment are manufactured to ensure that your sterile operation remains uncompromised. Choose from a variety of durable materials fabricated into products engineered with optimal functionality and cleanliness in mind.