Hardy Diagnostics W340 – SterEM™ Tryptic Soy Agar (TSA), Settle Plate, Gamma Irradiated, Air Monitoring, 10 plates. CORE USP 797/800 PLATE

Overview:
Engineered for 503A and 503B sterile compounding environments, Hardy Diagnostics SterEM™ W340 TSA settle plates deliver validated sterility assurance for passive air monitoring in compliance with USP <797> and USP <800>. Each 15 × 100 mm plate contains 26 mL of TSA and is triple-bagged, gamma-irradiated, and validated to a Sterility Assurance Level (SAL) of 10⁻⁶, ensuring maximum contamination control in ISO 5–8 clean zones, buffer rooms, and critical environments.

Key Features

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

• Triple-bagged, moisture-controlled packaging

• Optically clear polystyrene for distortion-free colony viewing

• Raised stacking rings for cleanroom workflows

• Manufactured in a cGMP and ISO 13485-certified facility

Typical Uses in Compounding Pharmacies

• Passive air monitoring (settle plates) in ISO 5 hoods, ISO 7 buffer zones, ISO 8 ante-rooms

• Routine environmental monitoring to meet USP <797>/<800> requirements

• Verification of cleanroom air quality in 503A/503B compounding and sterile manufacturing

• Companion to active air sampling and surface/fingertip testing protocols

Product Details

• Part Number: W340 (formerly W570)

• Medium: TSA (Tryptic Soy Agar), USP

• Plate Size: 15 × 100 mm, 26 mL fill

• Packaging: Triple-bagged, irradiated

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

• Manufacturer: Hardy Diagnostics

Additional Information

Validated for USP <797>/<800> cleanroom use, W340 TSA plates provide reliable growth support for environmental bioburden monitoring in aseptic areas. Each plate is sterilized by gamma irradiation (SAL 10⁻⁶) and packaged in a VHP-impermeable triple-bag configuration (two nylon inner bags, one Mylar® outer). Certificates of Analysis are available 24/7.