Hardy Diagnostics W370 – SterEM™ Sabouraud Dextrose Agar (SabDex), Irradiated Settle Plate (15×100 mm, Triple-Bagged), 10 plates

Overview:
Hardy Diagnostics W370 SterEM™ Sabouraud Dextrose Agar (SabDex) Settle Plates are engineered for high-assurance fungal air monitoring in 503A and 503B sterile compounding cleanrooms. Each 15 × 100 mm plate contains 26 mL of USP SabDex agar and is gamma-irradiated to a validated Sterility Assurance Level (SAL) of 10⁻⁶). The plates are triple-bagged for aseptic cleanroom transfer and resistant to VHP decontamination, ensuring compliance with USP <797> and USP <800> environmental monitoring requirements.

Ideal for ISO 5–8 clean zones, buffer rooms, and critical areas, W370 provides reliable detection of yeast and mold as part of routine fungal air monitoring or comprehensive cleanroom trending programs.

Key Features

• Gamma-irradiated (SAL 10⁻⁶) for validated sterility assurance

• Triple-bagged packaging for ISO 5–8 cleanroom transfer

• Formulated per USP SabDex specifications for optimal fungal recovery

• Optically clear polystyrene for distortion-free colony viewing

• Manufactured in an ISO 13485 and cGMP-certified facility

Typical Uses in Compounding Pharmacies

• Routine fungal air monitoring under USP <797>/<800> environmental programs

• Critical-area air monitoring (ISO 5–7 buffer zones) requiring irradiated packaging

• 503A/503B environmental trending in cleanrooms and hazardous drug areas

• Supplemental fungal detection alongside TSA settle plates (W340) for bacteria

Product Details

• Part Number: W370

• Medium: Sabouraud Dextrose Agar (SabDex), USP

• Plate Size: 15 × 100 mm, 26 mL fill

• Packaging: Triple-bagged, gamma-irradiated

• Storage: 15–30 °C; protect from light and contamination

• Manufacturer: Hardy Diagnostics

Additional Information

W370 plates are part of Hardy’s SterEM™ line of validated, irradiated media, offering enhanced sterility assurance and contamination control for sterile compounding environments. The gamma-irradiated packaging allows direct entry into aseptic areas, making these plates ideal for 503A/503B cleanrooms performing USP <797>/<800>-compliant environmental monitoring of yeast and mold.