Frequently Asked Questions

Purchase orders may be emailed to orders@ivqa.com. Please include bill-to/ship-to details, contact name, phone, item SKUs/quantities, and any special delivery instructions.

Yes. Visit the Shop to add items to your cart and check out securely with major credit cards.

Use our Order Tracking page to look up real-time status by Order ID and billing email. You can also contact support@ivqa.com or call (626) 629-0418 (Mon–Fri, 8 AM–4 PM PT).

Yes. The website currently supports shipping to the United States (including territories), Canada, and the United Arab Emirates. For other regions, please email orders@ivqa.com for assistance with a pro forma invoice and shipping options.

• Return window: Items may be returned within 30 days of purchase.
• Condition: Packaging must be unopened and in resalable condition.
• Restocking fee: 25% restocking fee applies to all returns.
• How to start a return: Email support@ivqa.com or call (626) 629-0418 (Mon–Fri, 8 AM–4 PM PT). Customer is responsible for return shipping.
• Refund timing: Refunds are typically processed 1–3 business days after inspection back to the original payment method.

USP Chapter <797>—“Pharmaceutical Compounding: Sterile Preparations”—sets standards for safe aseptic compounding across pharmacy settings. Updated categorization (Category 1, 2, 3), revised beyond-use dates, and enhanced environmental and personnel requirements became official on November 1, 2023, following publication on November 1, 2022.

• Introduction of compounding CSP categories (1–3) based on risk, environment, and process.
• New beyond-use date (BUD) criteria tied to these categories.
• More stringent facility, personnel garbing, and designated person requirements.
• Clearer definitions and expanded scope beyond prior versions.

The revised chapter published on November 1, 2022, and it became official on November 1, 2023. Regulatory jurisdictions may enforce this differently, so always check with your state board.

Each kit includes the components required for the category-specific aseptic simulation, Instructions for Use, log sheet, and a Certificate of Analysis.

Category-specific contents:

• Category 1 CSP Kit: Sterile TSB 10 mL vials (5 mL fill) ×12, empty 50 mL vials ×3, Whirl-Pak® bag, IFU, log sheet, CoA.
• Category 2 CSP Kit: Sterile TSB 50 mL vials ×3, empty 50 mL vials ×6, empty 10 mL vials ×3, Whirl-Pak® bag, IFU, log sheet, CoA.
• Category 3 CSP Kit: Non-sterile TSB powder (3 g) ×1, empty 10 mL vials ×9, Whirl-Pak® bag, IFU, log sheet, CoA.

Yes. Instructions for Use (IFU) and log sheets for each category are included in the kit and available on our website. A Certificate of Analysis (COA) for each lot is included in the kit packaging and can also be searched and downloaded here using your lot number and expiration date.

No. Our Media-Fill Test Kits are training/competency tools intended to simulate aseptic manipulations for compliance and quality assurance. They are for laboratory use only.

All IVQA Media-Fill Test Kits carry a 3-year expiration from date of manufacture. Always verify the lot-specific expiration on the kit label/COA.

Each empty sterile vial contains 0.2–0.3 mL of distilled water to facilitate the sterilization process. This trace amount ensures proper sterilization without compromising the kit’s intended use.

• Category 1 CSP (prepared in an ISO 5 PEC within an SCA; BUD ≤12 h RT or ≤24 h refrigerated): Use the Category 1 CSP Media-Fill Test Kit.
• Category 2 CSP (prepared in a cleanroom suite; BUDs beyond Category 1 limits): Use the Category 2 CSP Media-Fill Test Kit.
• Category 3 CSP (extended BUDs with additional QA controls, sterilization steps, and stricter garbing/monitoring): Use the Category 3 CSP Media-Fill Test Kit.

• Category 1 & Category 2 personnel: At least every 6 months.
• Category 3 personnel: At least every 3 months.
• Initial qualification: Occurs before a compounder is permitted to compound independently and includes media-fill, gloved-fingertip sampling, and related competencies.

Note: Designated Supervisors who oversee compounding (even if they do not compound) require periodic competency assessment per USP <797>.

Use non-bacteriostatic water to reconstitute the supplied dehydrated TSB powder before filtering through the 0.2 µm filter during the test procedure.

Your facility SOP may specify either single-temperature incubation for 14 days or a dual-temperature sequence (7 days at 20–25 °C plus 7 days at 30–35 °C). When using dual temperatures, document the order and timing on the log sheet.

• Pass: No visible turbidity/precipitation in the test vials at the end of the prescribed incubation period.
• Fail: Any visible growth at any point during incubation in a test vial.
• Controls: For Category 3, control vials are expected to show growth; filtered vials should remain clear (no growth).

All current log sheets are available on our website by category. Each kit also includes a printed log sheet.

A COA is included inside each kit. For a digital copy, use our COA Search page with your lot number and expiration date.

Yes. Each lot is growth-promotion and sterility tested; details are shown on the lot-specific COA.