
Reagents & materials
Visible particle inspection - Reagents & Materials
What you need to perform one test: reagents, kits, consumables, equipment and quality controls, with their official basis. Quantities follow the validated method or the manufacturer's instructions for use (IFU).
Pharmaceuticals biopharma cell therapies & medical devices · General
Visible particle inspection
Parenteral product appearance
Reagents & stains
| Item | Amount per test | Procure |
|---|---|---|
| No stain or dye requiredPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
Consumables & materials
| Item | Amount per test | Procure |
|---|---|---|
| Filled product containersPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
| Qualified particle-reference containersPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
| Inspection recordsPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
Equipment
| Item | Amount per test | Procure |
|---|---|---|
| Qualified visible-particle inspection station with appropriate backgroundsPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
| Controlled illuminationPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
| Suitable handling aidsPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
Controls & reference materials
| Item | Amount per test | Procure |
|---|---|---|
| Known acceptablePer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
| Defect/reference containersPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
| Inspector qualification materialsPer validated method / manufacturer IFU | Per validated method / manufacturer IFU | MerckMerck (Sigma-Aldrich)Recommended · Official manufacturer site |
Official basis (Framework): USP Chapter 790 addresses visible particulates in injections. This is optical inspection, not staining; use the current compendial and product specific requirements.
Procurement note: The public chapter preview establishes scope only. Obtain the current full compendial chapter for inspection-system requirements.
Sources:G115 USP
Procurement links open the manufacturer's or distributor's page in a new tab. STAINIC does not sell these items; always buy products validated for diagnostic use and follow local regulations.
