IVQA Medium-Complexity Media Fill Test Kit will provide you the tools to comply with the Media Fill Test Procedure standards in USP <797> on aseptic manipulation skills, including representative sterile microbial culture transfer and fill challenges. Our test kits are designed to document correct personal technique and effective environmental control for the preparation of low complexity compounded sterile products (CSP’s). All employees compounding medium complexity preparations must have successfully passed the medium complexity media fill test procedure at least annually. The annual completion of this test along with the quarterly re-validation tests, will satisfy the requirements for staff members who are involved in medium complexity CSP. Administration should maintain documentation of employees successfully passing the medium complexity media test procedure and the timely annual documented reassessment.
Revised USP <797> regulations mandate that training programs include a hands-on demonstration and practice with actual items such as CSP containers, devices and equipment. Regulations also require the caregiver practice aseptic and injection technique under the direct observation of a health professional. The caregiver is expected to demonstrate mastery of assigned activities before being allowed to administer CSP’s unsupervised by a health professional.
IVQA media contains Tryptic Soy Broth, which helps detect evidence of a wide variety of microorganisms, especially common aerobic and facultative anaerobic bacteria.
In an ISO class 5 air quality environment, set up 3 50-mL vials containing test media (total of 3 vials).
Set up 3 sets of two each, empty 50-mL sterile capped vials (total of 6 vials).
Now, by use of a syringe, transfer approximately 25 ml into each of the 6 empty 50-mL vials from the 3 test media vials provided.
This step is intended to match your usual workplace activities. If your usual workplace activities includes the use of transfer tubing sets you have the following option. Rather than use of a syringe, use IV transfer tubing sets and vented needles or spikes, to transfer approximately 25 ml into each of the 6 empty 50-mL vials from the 3 test media vials provided.
Perform 4 aseptic transfers of 5 ml aliquots between each set of 2 vials with a syringe and needle. Repeat these 4 transfers for each of the 3 pairs.
Aseptically transfer 5 ml from each of the 2 vial sets into a 10 ml sterile vial. When you have done this for each set you will have three 10-ml vials filled with media. Cover each 10 ml vial with a sterile adhesive seal.
Incubate the three 10 ml vials at 25 to 35 degrees for 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:
- The test must be carried out to completion without interruptions.
- Test performance conditions should mimic the usual work environment.
Appropriate Medium-Complexity Use:
To understand when a Medium-Complexity Media Test Kit is appropriate, below is a USP description of Medium Complexity CSPs.
- Involves using multiple pooled sterile commercial products for multiple patients or one patient multiple times
- Involves complex aseptic manipulations (TPN or other multiple-ingredient CSPs)
- Compounding occurs over a prolonged period of time (complex procedures)
- No bacteriostatic agents are added to the preparation and it is administered over several days (chemotherapy or pain management administered via implanted infusion device)
- Environmental conditions and quality assurance procedures comply with low-complexity guidelines
- Requires more challenging annual media-fill evaluation of compounding personnel technique that simulates the most challenging or stressful conditions