Hardy Diagnostics
Hardy Diagnostics W390 – SterEM™ R2A Agar, Irradiated Settle Plate (15×100 mm, Triple-Bagged), 10 plates
Hardy Diagnostics W390 – SterEM™ R2A Agar, Irradiated Settle Plate (15×100 mm, Triple-Bagged), 10 plates
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Overview:
The Hardy Diagnostics W390 SterEM™ R2A Agar Settle Plate is designed for environmental air monitoring in controlled cleanroom environments, particularly where low-nutrient or stressed microorganisms may be present. Each 15 × 100 mm plate contains R2A Agar, USP, a low-nutrient medium ideal for detecting microorganisms that survive under oligotrophic (nutrient-limited) conditions — such as those found in purified water systems or low-bioburden cleanrooms.
Triple-bagged and gamma-irradiated to a validated Sterility Assurance Level (SAL) of 10⁻⁶, these plates meet the expectations of USP <797> and USP <800> for 503A and 503B compounding pharmacies, supporting environmental trending and sterility assurance in ISO 5–8 classified areas.
Key Features
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R2A Agar, USP formulation for detection of slow-growing or stressed organisms
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Gamma-irradiated (SAL 10⁻⁶) for cleanroom sterility assurance
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Triple-bagged packaging for aseptic transfer into ISO 5–8 zones
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Low-nutrient medium enhances recovery of oligotrophic organisms from air or surfaces
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Manufactured under cGMP and ISO 13485 certified quality systems
Typical Uses in Compounding Pharmacies
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Air monitoring in low-bioburden or water-associated cleanrooms
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Supplemental media alongside TSA (W340) and SabDex (W70) to broaden organism recovery
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Trending of slow-growing bacteria that may not appear on TSA or SabDex plates
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Monitoring purified water or humidified cleanroom systems for microbial contamination
Product Details
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Part Number: W390
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Medium: R2A Agar, USP
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Plate Size: 15 × 100 mm, 26 mL fill
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Packaging: Triple-bagged, gamma-irradiated
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Storage: 15–30 °C; protect from light and contamination
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Manufacturer: Hardy Diagnostics
Additional Information
R2A Agar (Reasoner’s 2A) is a low-nutrient formulation that promotes recovery of stressed, slow-growing, or chlorine-tolerant bacteria often found in water systems and cleanroom air. The W390 SterEM™ format provides the same validated sterility assurance and triple-bag packaging as Hardy’s TSA and SabDex settle plates, allowing seamless integration into USP <797>/<800> environmental monitoring programs for 503A/503B pharmacies.
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