Tryptic Soy Broth (TSB), 100 mL (8 oz), Paragon Clean Room Grade, 1/Pk

This product provides 100 mL of Tryptic Soy Broth (TSB) packaged in a premium 8 oz Paragon glass bottle. This specific configuration is manufactured as Clean Room Grade, designed to meet the rigorous sterility and particulate standards of pharmaceutical manufacturing, compounding pharmacies, and critical environmental monitoring.

The "Clean Room" Standard:

This is not standard benchtop media. "Clean Room Grade" implies a higher level of processing and validation:

1. Terminal Sterilization: The media is strictly processed to ensure a Sterility Assurance Level (SAL) suitable for critical zones (ISO 5 / Class 100). The packaging is typically double-bagged to allow for safe transfer into sterile environments.

2. Particulate Control: The manufacturing process strictly limits particulate matter, ensuring the liquid is crystal clear. This is vital because turbidity (cloudiness) is the only indicator of bacterial growth in a media fill test; false "cloudiness" from dust or precipitate would ruin the test.

3. VHP Compatibility: The packaging is typically designed to withstand Vaporized Hydrogen Peroxide (VHP) decontamination surfaces, allowing it to be wiped down or gassed into isolators.

The Media Fill Test (Aseptic Validation):

This product is the industry standard for Media Fill Simulations (Process Simulation Testing).

• The Concept: Instead of filling vials with liquid medicine, operators fill them with this sterile TSB using the exact same machinery, tubing, and procedures used in production.

• The Volume: The 100mL fill provides ample volume to simulate medium-batch compounding or to fill multiple smaller vials/syringes from a single source bottle.

The Bottle:

The Paragon style bottle is a tall, narrow glass bottle often preferred for its:

• Clarity: Excellent visibility for reading results.

• Durability: Heavy-walled glass resists breakage.

• Closures: Equipped with a secure screw cap to maintain integrity during transport and handling.

Common Applications:

• USP <797> Compounding: Validating the aseptic technique of pharmacy technicians (Personnel Gloved Fingertip & Media Fill Verification).

• USP <71> Sterility Testing: Detecting contamination in pharmaceutical products.

• Biotech Production: Fermentation starter cultures in clean environments.

• Equipment Validation: verifying the sterility of pumps, tubes, and filling needles.

Key Features:

• Pharma Grade: Designed for use in ISO-accredited cleanrooms and isolators.

• Validation Ready: Essential for Media Fill/Process Simulation Testing.

• High Clarity: Particulate-free to prevent false positives during visual inspection.

• Robust Packaging: 8 oz Paragon glass bottle offers chemical resistance and durability.

• Standard Formulation: Soybean-Casein Digest Medium meets USP/EP/JP harmonized requirements.

• Format: Sterile liquid in a 100mL fill glass bottle (1/Pack).

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