● Catalog No. MFT01
● Compliance with USP Chapter <797>
● Kit Contains:
◦ Sterile Test Media (Tryptic Soy Broth) 10ml Vials, 5ml Fill – 12 vials
◦ Sterile 50ml Empty Serum Vials – 3 vials
◦ Whirl-Pak® Bag – 1 bag
◦ Log Sheet
Category 1 CSP Media-Fill Test Kit
$81.00
The Category 1 CSP Media-Fill Test Kit by IVQA validates compounding personnel’s aseptic technique and sterile compounding proficiency. Intended for simulating Category 1 compounded sterile preparations, it evaluates the risk of microbial contamination and assesses competency in aseptic techniques. Suitable for the initial assessment and every 6-month revalidation of aseptic manipulation competency, in accordance with USP Chapter <797> guidelines. This product is quality control tested for growth promotion and sterility.
USP Chapter <797> Category 1 CSP Guidelines
Description:
-
- Verifies aseptic techniques for preparations with a Beyond-Use Date (BUD) of 12 hours or less at controlled room temperature or 24 hours or less when refrigerated.
- Applicable for simple aseptic manipulations typically in less controlled environmental conditions.
- Ideal for verifying technique in single transfers from ampules or vials, straightforward reconstitutions, or dilutions.
- All compounding activities must be performed in an ISO Class 5 or better air quality environment to minimize the risk of contamination.
Examples:
-
- Transferring a medication from a single-dose vial to a syringe for immediate administration.
- Mixing a powdered medication with a sterile diluent in a single vial.
- Opening an ampule and transferring its contents to a syringe or a sterile container for immediate use.
- Adding a single medication to an IV bag using aseptic techniques.
- Drawing up medications into syringes for immediate administration to a patient.
- Mixing two sterile products in a single container when the procedure is straightforward and quick.
Initial Training and Competency:
-
- Before beginning independent compounding or having direct oversight of compounding personnel, individuals must successfully complete an initial aseptic manipulation competency evaluation.
- This initial evaluation includes visual observation, media-fill testing, gloved fingertip and thumb sampling on both hands, and surface sampling of the direct compounding area.
Frequency of Ongoing Competency Testing:
-
- Aseptic manipulation competency evaluations must occur at least every 6 months for personnel compounding Category 1 CSPs.
Test Procedure:
Within an ISO Class 5 air quality environment, arrange the vials into three sets, each containing four 10ml vials filled with 5ml test media, along with one empty 50ml serum vial.
Using a syringe equipped with a vented needle, aseptically transfer 5ml of Tryptic Soy Broth test media from each 10ml vial into one empty 50ml serum vial, ensuring a total volume of 20ml per 50ml vial. Repeat this process for the remaining sets of vials.
Write your name and date of preparation on the three 50ml vial labels, one from each set. Then, aseptically apply a sterile adhesive seal to the rubber closures and place the sealed vials inside the provided Whirl-Pak® bag for transfer to the incubator.
Incubate the three 50ml vials at 20°–25°C (68°– 77°F) and 30°–35°C (86°– 95°F) for a minimum of 7 days at each temperature range to detect a broad spectrum of microorganisms. A total incubation period of at least 14 days is recommended to confirm the absence of microbial growth. Any signs of microbial growth, such as turbidity or precipitation, at any point during the incubation period, indicates a failure in the sterility test.
Once the test is initiated:
- Must be carried out to completion without interruptions.
- Performance conditions should mimic the usual work environment.
References:
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- USP Chapter <797> guidelines can be found in the current version of the United States Pharmacopeia and National Formulary (USP–NF), which outlines the standards for sterile compounding procedures and quality assurance practices.
- Whirl-Pak® is a registered trademark of Nasco International, Inc.
| Weight | 1.4 lbs |
|---|---|
| Dimensions | 2 × 12 × 12 in |
