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
Low Complexity Media-Fill Test Kit
$81.00
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
Description:
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- Involves only transfer, measuring, and mixing with closed or sealed packaging systems
- Limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles or syringes, transferring sterile liquids in sterile syringes to sterile administration devices
- Prepared entirely in an ISO Class 5 or better air quality environment
- In the absence of passing a sterility test, storage for a maximum of 48 hours at room temperature, 14 days refrigerated, or 45 days in solid frozen state
Examples:
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- Single transfers of sterile dosage forms from ampules, bottles, bags, and vials using sterile syringes with sterile needles
- Manually measuring and mixing no more than 3 manufactured products to compound drug admixtures and nutritional solutions
Frequency of QA Testing:
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- Annual testing for each person who compounds low complexity sterile preparations
Source of complexity level guidelines: www.uspnf.com
Test Procedure:
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:
- Must be carried out to completion without interruptions
- Performance conditions should mimic the usual work environment
Instructional Video
| Weight | 1.4 lbs |
|---|---|
| Dimensions | 2 × 12 × 12 in |
