Description for the Low-Risk Level Kit (CHHVL1):
Low-Risk Level Media-Fill Challenge Test Kit is recommended for routine use in the monitoring of aseptic procedures used in Compounding Sterile Preparations (CSPs). The kit contains the necessary materials for one pharmacist or technician to perform the low-risk level media-fill challenge testing as specified in USP Chapter <797>.
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Packaging: 1 pc
Description for the Medium-Risk Level - Comprehensive (CHHVM1):
Tryptic Soy Broth, the medium used in the media-fill challenge testing, is widely used for the cultivation of microorganisms from environmental sources supporting the growth of the majority of bacteria and fungi. Tryptic Soy Broth, also known as TSB or Soybean-Casein Digest Broth, conforms to the formula given by the U.S. Pharmacopeia.(1) This medium contains digests of soybean meal and casein, which provide amino acids and other nitrogenous substances, making it a highly nutritious medium for a variety of organisms. Sodium chloride is added to maintain the osmotic equilibrium. Dextrose is incorporated as an energy source. The dipotassium phosphate is included in the formulation as a buffer to maintain the proper pH.
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Packaging: 1 pc
Description for the Medium-Risk Level - Basic (CHHVM2):
Tryptic Soy Broth, the medium used in the media-fill challenge testing, is widely used for the cultivation of microorganisms from environmental sources supporting the growth of the majority of bacteria and fungi. Tryptic Soy Broth, also known as TSB or Soybean-Casein Digest Broth, conforms to the formula given by the U.S. Pharmacopeia.(1) This medium contains digests of soybean meal and casein, which provide amino acids and other nitrogenous substances, making it a highly nutritious medium for a variety of organisms. Sodium chloride is added to maintain the osmotic equilibrium. Dextrose is incorporated as an energy source. The dipotassium phosphate is included in the formulation as a buffer to maintain the proper pH.
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Packaging: 1 pc
Additional Information:
FORMULA
Ingredients per liter of deionized water:*
- Pancreatic Digest of Casein 17.0gm
- Sodium Chloride 5.0gm
- Papaic Digest of Soybean Meal 3.0gm
- Dextrose 2.5gm
- Dipotassium Phosphate 2.5gm
Final pH 7.3 +/- 0.2 at 25°C
*Adjusted and/or supplemented as required to meet performance criteria.
STORAGE AND SHELF LIFE
Storage: Upon receipt store at 2-25°C away from direct light. Media should not be used if there are any signs of deterioration (discoloration), contamination, or if the expiration date has passed. Protect from light, excessive heat, moisture, and freezing.
The expiration date on product label applies to the product in its intact packaging when stored as directed.
