Hardy Diagnostics W385 – SterEM™ TSA w/ Lecithin & Tween 80, Irradiated, Settle Plate (15×100 mm, Triple-Bagged), 10 plates

Overview:
Designed for 503A and 503B sterile compounding and cleanroom environments, the Hardy Diagnostics W385 SterEM™ TSA with Lecithin & Tween 80 Settle Plate provides high-sterility assurance for air monitoring after disinfection or cleaning cycles. Each 15 × 100 mm plate contains 26 mL of Tryptic Soy Agar supplemented with Lecithin and Polysorbate 80 (Tween 80) to neutralize common disinfectants such as quaternary ammonium compounds and phenolics.

Plates are gamma-irradiated, triple-bagged, and validated to a Sterility Assurance Level (SAL) of 10⁻⁶, meeting USP <797>/<800> requirements for environmental monitoring in aseptic areas.

Key Features

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

• Neutralizing formulation (Lecithin & Tween 80) deactivates sanitizer residues

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

• Optically clear polystyrene for distortion-free colony observation

• Validated under cGMP and ISO 13485 quality systems

Typical Uses in Compounding Pharmacies

• Post-disinfection or cleaning air monitoring (settle plate method) in ISO 5–8 rooms

• Recovery studies and environmental validation after sanitizer application

• Routine air monitoring where disinfectant carryover could inhibit microbial recovery

• Part of USP <797>/<800> environmental monitoring and trending programs

Product Details

• Part Number: W385

• Medium: TSA (Tryptic Soy Agar) + Lecithin & Polysorbate 80 (Tween 80)

• 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

Hardy’s SterEM™ neutralizing TSA settle plates are specifically formulated for air monitoring in areas where disinfectants may interfere with microbial recovery. The inclusion of Lecithin and Tween 80 neutralizes quaternary ammonium and phenolic compounds without compromising agar performance, ensuring accurate results during post-cleaning validation and USP <797>/<800> compliance monitoring.