USP Chapter <797> Compliant
Each Kit Contains:
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- Tryptic Soy Broth (TSB) Non-sterile powder – 1 container
- Sterile 10ml Empty Serum Vials – 9 vials
- Instructional Sheet
- Log Sheet
High Complexity Media-Fill Test Kit
$74.00
The CSP High 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 high 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> High Complexity Guidelines
Description:
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- Non-sterile ingredients are incorporated or a non-sterile device is employed before terminal sterilization
- Non-sterile components are exposed for at least 6 hours before being sterilized
- Exposed to air quality inferior to ISO Class 5
- In the absence of passing a sterility test, storage for a maximum of 24 hours at room temperature, 3 days refrigerated, or 45 days in a solid frozen state
Examples:
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- Dissolving non-sterile bulk drug and nutrient powders to make solutions, which will be terminally sterilized
- Measuring and mixing sterile ingredients in non-sterile devices before sterilization is performed
Frequency of QA Testing:
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- Semi-annual for each person who compounds high complexity sterile preparations
Source of complexity level guidelines: www.uspnf.com
Test Procedure:
Outside an ISO Class 5 air quality environment, dissolve the included 3 grams of non-sterile Soybean-Casein Digest Broth in 100ml of non-bacteriostatic water to make a 3% solution.
Withdraw 25ml of test media into each of three 30ml sterile syringes.
Transfer 5ml from each syringe into separate empty sterile 10ml serum vials. Label these vials as controls. These vials will generate exponential microbial growth, indicated by visible turbidity upon incubation.
Under aseptic conditions, in an ISO Class 5 air quality environment, and using aseptic techniques, affix a sterile 0.2-μm porosity filter unit and a 20 gauge needle to each syringe. Inject 10ml from each syringe into each of two empty sterile 10ml serum vials.
Repeat the process with each of the three syringes, injecting 10ml aliquots into each of two, 10ml serum vials. On all 6 vials, record the name and date of pharmacist or technician completing this test.
Affix sterile adhesive seals to the closure of the nine vials, and incubated them at 25° to 35°C. Inspect for microbial growth over 14 days. Sterile vials will remain clear and without bubbles, precipitate, cloudiness or changes in turbidity. Cloudiness, turbidity, bubbles or a precipitate on the bottom of any of the vials indicates bacterial contamination. All 6 vials must be sterile to constitute a passed test. The 3 control vials should become turbid or develop a precipitate demonstrating bacterial growth.
Once the test is initiated:
- Must be carried out to completion without interruptions
- Performance conditions should mimic the usual work environment
Instructional Video
| Weight | 1.0 lbs |
|---|---|
| Dimensions | 1.2 × 12 × 6 in |
