Results Log Sheets
Our results log sheets guide you to document each media-fill test accurately and consistently—helping you meet and exceed USP <797> requirements. Each log sheet is designed for clarity, ease of use, and alignment with regulatory expectations so teams can execute, document, and review results with confidence.
Need the step-by-step procedure? See the Instructions for Use page.
Category 1 CSP
ISO 5 PEC within an SCA; short-duration preparations- Before Incubation: Enter Lot Number, Expiration Date, and Hood Number.
- Incubation Timing: For each vial in result set (1–3), record Start (date/time), Temperature One (20–25 °C), Adjusted (date/time), Temperature Two (30–35 °C), and End (date/time).
- After Incubation: Record each vial’s result as Pass/Fail and add a brief note if needed.
- Finalize: Complete Employee signature/date and Supervisor acknowledgment.
Category 2 CSP
Extended BUDs; cleanroom suite with ISO 5 PEC- Before Incubation: Enter Lot Number, Expiration Date, and Hood Number.
- Incubation Timing: For each vial in result set (1–3), record Start (date/time), Temperature One (20–25 °C), Adjusted (date/time), Temperature Two (30–35 °C), and End (date/time).
- After Incubation: Record each vial’s result as Pass/Fail and add a brief note only if needed.
- Finalize: Complete Employee signature/date and Supervisor acknowledgment.
Category 3 CSP
Extended BUDs beyond Category 2; cleanroom suite with stricter controls- Before Incubation: Enter Lot Number, Expiration Date, and Hood Number.
- Incubation Timing: For each vial (Controls 1–3 and Filtered 1–6), record Start (date/time), Temperature One (20–25 °C), Adjusted (date/time), Temperature Two (30–35 °C), and End (date/time).
- After Incubation: Record controls as Growth/No Growth and filtered vials as Pass/Fail.
- Finalize: Complete Employee signature/date and Supervisor acknowledgment.
Need help?
Questions about completing the log sheet or interpreting outcomes? Email support@ivqa.com or see our FAQs.