USP Chapter <797> Compliant
Each Kit Contains:
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- Sterile 10ml (TSB) Test Media Vials – 12 vials
- Sterile 50ml Empty Serum Vials – 3 vials
- Instructional Sheet
- Log Sheet
The CSP Low Complexity Media-Fill Test Kit by IVQA is recommended for routine use in the monitoring of aseptic procedures used in Compounding Sterile Preparations (CSPs). The kit contains all of the necessary materials for one pharmacist or technician to perform the low complexity level media-fill challenge as specified in USP Chapter <797>. Instructions and test results log sheet included with each kit. This product is quality control tested for growth promotion and sterility.
USP Chapter <797> Low Complexity Guidelines
Source of complexity level guidelines: www.uspnf.com
In an ISO Class 5 air quality environment, set up three sets of 10ml vials, each set containing four vials (total of twelve vials).
Set up three 50ml sterile empty serum vials.
Now, by use of a syringe and vented needle combination, transfer all the contents from four of the vials into an empty 50ml serum vial. This should be a total of 20ml in each 50ml vial. Repeat this procedure for Set 2 and Set 3. (Note: In the transfer process, insert the needle into the rubber stopper and empty the syringes contents.
Label each vial with the employee’s name, and the date and time the vials were prepared.
Aseptically affix a sterile adhesive seal to each of the three filled vials (i.e. in addition to the stoppers, the top of the vial must be covered with another seal).
Incubate the three 50ml vials at the 25 to 35 degrees of 14 days, if at the end of this time the solution is clear this denotes a pass, if it is turbid or has a precipitate this indicates a failure. In most cases, a vial that fails to pass will become turbid or develop precipitate within 7 days.
Once the test is initiated:
Weight | 1.4 lbs |
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Dimensions | 2 × 12 × 12 in |