Instructions for Use
Our step-by-step instructions guide you through performing each media-fill test accurately and consistently—helping you meet and exceed USP <797> requirements. Each IFU is written for clarity, ease of use, and alignment with regulatory expectations so teams can execute, document, and review results with confidence.
Looking for results documentation? The dedicated Log Sheets page has printable result logs for each kit category.
Category 1 CSP
ISO 5 PEC within an SCA; short-duration preparations- Prepare 3 sets in an ISO Class 5 PEC.
- Each set: combine four 10 mL TSB vials (5 mL each) into one 50 mL vial (final 20 mL).
- Label, seal, and bag vials per SOP; maintain chain of custody.
- Incubate at 20–25 °C and 30–35 °C for a combined minimum of 14 days (e.g., 7 days at each temperature).
- Any turbidity or precipitation indicates test failure; investigate and retrain per SOP.
Frequency: Initial qualification and every 6 months thereafter per USP <797>
Category 2 CSP
Extended BUDs; cleanroom suite with ISO 5 PEC- Arrange 3 sets in ISO Class 5 PEC: each set has one 50 mL TSB vial, two empty 50 mL vials, and one empty 10 mL vial.
- Transfer 25 mL from the TSB vial into each empty 50 mL vial using a vented needle or vented transfer set.
- Perform four aseptic cross-transfers of 5 mL between the two 50 mL vials.
- Transfer 5 mL from each 50 mL vial into the empty 10 mL vial to a final volume of 10 mL.
- Incubate at 20–25 °C and 30–35 °C for a combined minimum of 14 days (e.g., 7 days at each temperature).
- Any turbidity or precipitation indicates test failure; investigate and retrain per SOP.
Frequency: Initial qualification and every 6 months thereafter per USP <797>
Category 3 CSP
Extended BUDs beyond Category 2; cleanroom suite with stricter controls- Reconstitute 3 g dehydrated TSB with 100 mL non-bacteriostatic water (outside ISO 5); cap and shake until dissolved.
- Move to ISO Class 5. Prepare 3 sets of three 10 mL vials; label one vial in each set as Control 1–3.
- Withdraw 25 mL of reconstituted media into each of three 30 mL syringes. Dispense 5 mL into each Control vial (20 mL remains per syringe).
- Attach a 0.2 µm filter + 20-g needle to each syringe; inject 10 mL (filtered) into the two non-control vials per set.
- Incubate at 20–25 °C and 30–35 °C for a combined minimum of 14 days (e.g., 7 days at each temperature). Controls expected to show growth; filtered vials should remain clear.
Frequency: Initial qualification and every 3 months thereafter per USP <797>
Need help?
Questions on setup, incubation, or interpreting results? Email support@ivqa.com. For general guidance, see our FAQs.