USP RINSING AND DILUTING FLUIDS

Cat. no. K205 Fluid A, USP, 20x125mm Tube, 18ml 20 tubes/box
Cat. no. U13 Fluid A, USP, 4oz. Glass Bottle, 100ml 20 bottles/box
Cat. no. U17 Fluid A, USP, 180ml Wide Mouth Jar, 90ml 12 jars/box
Cat. no. U19 Fluid A, USP, 125ml Polypropylene Bottle, 100ml 12 bottles/box
Cat. no. U109 Fluid A, USP, 100ml Serum Bottle, 100ml 20 bottles/box
Cat. no. U249 Fluid A, USP, 16oz. Glass Bottle with septum cap, 600ml 10 bottles/box
Cat. no. U208 Fluid A, USP, 1L Polycarbonate Bottle, 1000ml 10 bottles/box
Cat. no. U209 Fluid A, USP, 250ml Serum Bottle, 200ml 10 bottles/box
Cat. no. U342 Fluid A, USP, 500ml Glass Bottle, 300ml 10 bottles/box
Cat. no. U349 Fluid A, USP, 500ml Polycarbonate Bottle, 300ml 10 bottles/box
Cat. no. U436 Fluid A, USP, 8oz. Glass Bottle, 200ml 12 bottles/box
Cat. no. U110 Fluid D, USP, 100ml Glass Bottle, 100ml 20 bottles/box
Cat. no. U115 Fluid D, USP, 1L Polycarbonate Bottle, 1000ml 10 bottles/box
Cat. no. U135 Fluid D, USP, 180ml Wide Mouth Jar, 100ml 12 jars/box
Cat. no. U210 Fluid D, USP, 500ml Polycarbonate Bottle with septum cap, 300ml 10 bottles/box
Cat. no. U215 Fluid D, USP, 500ml Polycarbonate Bottle with septum cap, 500ml 10 bottles/box
Cat. no. U346 Fluid D, USP, 500ml Glass Bottle with septum cap, 300ml 10 bottles/box
Cat. no. U437 Fluid D, USP, 4oz. Glass Bottle, 100ml 20 bottles/box
Cat. no. U206 Fluid K, USP, 1L Polypropylene Bottle, 1000ml 10 bottles/box
Cat. no. U348 Fluid K, USP, 500ml Glass Bottle with septum cap, 300ml 10 bottles/box

INTENDED USE

Hardy Diagnostics USP Fluids A, D, and K are used by the pharmaceutical and medical device industry in procedures used to ensure sterility of injectables, non-injectables, liquid products, oils and ointments, antibiotic powders, sterile pathway devices and aerosols.(1)

SUMMARY

Hardy Diagnostics USP Fluids A, D, and K are formulated by the USP guidelines for use by the pharmaceutical and medical device industry to ensure sterility of pharmaceuticals and medical devices. The three fluids have specific applications as defined by the U.S. Pharmacopeia (USP) for diluting, neutralizing, dissolving and rinsing of devices and membrane filters.(1)

Fluid A, USP is a 0.1% peptone solution and if appropriate to the test being performed, beta-lactamase may be added to neutralize any residual antibiotic activity on membrane surfaces. Fluid A, USP has wide applications for use with many different types of test articles including use with bacteriostatic or fungistatic articles or articles that contain a preservative, as Fluid A is recommended in validation tests of bacteriostasis and fungistasis by the USP. Other uses of Fluid A, USP are as a diluting fluid for both miscible and immiscible liquids and the dissolving of antibiotic powders followed by membrane filter rinses.(1)

Fluid D, USP is a 0.1% peptone solution, same formulation as Fluid A, USP, plus Tween® 80. Fluid D, USP also has several applications. Fluid D, USP can be used in validation test for bacteriostasis and fungistasis in articles containing lecithin, oil or a preservative. Fluid D, USP is also used as a membrane filter wash solution when testing ointments and oils. For sterile aerosol products, Fluid D, USP is used as a diluting solution. For devices labeled as "sterile pathway", Fluid D, USP is used to pass through each device.(1)

Fluid K, USP is a 0.5% peptone solution plus beef extract and Tween® 80. For those substances that contain petrolatum, Fluid K, USP is used both for moistening filter membranes prior to filtration and washing filter membranes following filtration.(1)

FORMULA

Ingredients per liter of deionized water*

Fluid A, USP
Meat Peptone 1.0gm

Final pH 7.1+/- 0.2 at 25ºC.

Fluid D, USP
Meat Peptone 1.0gm
Tween® 80 1.0ml

Final pH 7.1 +/- 0.2 at 25ºC.

Fluid K, USP
Meat Peptone 5.0gm
Beef Extract 3.0gm
Tween® 80 10.0ml

Final pH 6.9 +/- 0.2 at 25ºC

* Adjusted and/or supplemented as required to meet performance criteria.

STORAGE AND SHELF LIFE

Storage: Upon receipt store at 2-25ºC. 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. Product is light and temperature sensitive; protect from light, excessive heat, moisture, and freezing.

PRECAUTIONS

PROCEDURE

It is recommended that all procedures involving the use of USP Fluids A, D, and K follow the guidelines as outlined in the U.S. Pharmacopeia (USP) Standard.

INTERPRETATION OF RESULTS

Interpretation of results would be those as defined by the U.S. Pharmacopeia (USP) Standard.

LIMITATIONS

MATERIALS REQUIRED BUT NOT PROVIDED

Standard microbiological supplies and equipment such as loops, other culture media, swabs, applicator sticks, incinerators, and incubators, etc., as well as serological and biochemical reagents, are not provided.

QUALITY CONTROL

Test Organisms Inoculation Method* Incubation Results
Time Temperature Atmosphere
Staphylococcus aureus
ATCC® 6538
J 24hr 30 - 35°C Aerobic Growth
Pseudomonas aeruginosa
ATCC® 9027
J 24hr 30 - 35°C Aerobic Growth
Bacillus subtilis
ATCC® 6633
J 24hr 30 - 35°C Aerobic  Growth
Candida albicans
ATCC® 10231
J 24hr 20 - 25°C Aerobic Growth
Escherichia coli
ATCC® 8739
J 24hr 30 - 35°C Aerobic Growth
Salmonella enterica ATCC® 14028 J 24hr 30 - 35°C Aerobic Growth
Aspergillus brasiliensis ATCC® 16404 J 24hr 20 - 25°C Aerobic Growth

* Refer to the document "Inoculation Procedures for Media QC" on the Hardy Diagnostics Technical Document website for more information.

User Quality Control

PHYSICAL APPEARANCE

USP Fluids A, D, and K should appear clear, and light to medium amber in color.

REFERENCES

1. The Official Compendia of Standards. USP-NF. United States Pharmacopeial Convention, Rockville, MD.

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