When must Visual inspectors be qualified?
Inspectors are qualified if their detection of rejects is ≥ 70% detection of known rejects and ≤ 30% of blanks (false reject) in any given test set. The inspector must meet this requirement three (3) times before being considered a qualified manual visual inspector.
What is required for visual inspection?
A visual inspection is an inspection of an asset made using only the naked eye. This kind of inspection does not necessarily require any special equipment, but it does require special training so that the inspector knows what to look for as they visually review the asset.
How can I improve my visual inspection?
Here’s a recap for how to improve visual inspection of products:
- Apply the 80-20 principle.
- Have a clear baseline of what’s good and what’s not good.
- Process spot checks.
- Redesign the process when needed.
- Training and certification process.
What is visual inspection in pharma?
Visual inspection aims to determine the absence or presence of visible particles within parenteral products. Visual inspection is performed by trained human operators using their naked eye.
What is a Knapp test?
Particle test set (Knapp-Test): Sets that contain only particles. These are particles having the size from 50µm to 1000µm and consisting of different materials (plastic, the material stoppers are made of, glass, metal). Hence, they are “non-static”, i.e. the defect is in the container or in the drug solution.
What are the steps in visual inspection?
Generally, here are 5 simple steps to effectively perform visual inspections:
- Step #1 Clearly define defect criteria.
- Step #2 Standardize inspection performance.
- Step #3 Analyze visual defects.
- Step #4 Communicate improvement measures.
- Step #5 Use mobile-ready checklists.
- Take a snapshot of day-to-day issues.
What type of test is visual inspection test?
Visual Inspection (VI), or visual testing (VT), is the oldest and most basic method of inspection. In its simplest form, visual inspection is the process of examining a component or piece of equipment using one’s naked eye to look for flaws. Optical aids such as illuminators, mirrors, borescopes, etc.
What is Knapp test?
Which instrument is used for visual inspection?
Non Destructive Testing (NDT) is concerned with all methods of detecting flaws in materials and can be performed optically using non-specialised visual inspection equipment such as Microscopes, Endoscopes or Borescopes.
Why is visual inspection of parenteral solutions important?
Visual inspection ranks as an essential operation in parenteral drug production to ensure the safety of the drug product in its container, such as a vial or syringe.
What is visual inspection of injectables?
Visual inspection of injections (parenteral) was originally developed and it’s still mainly targeted in order to find and remove products containing unwanted particles. This is necessary to minimize the risk of introducing such particles to patient’s body during the delivery of injectable medications.
Why is visual inspection of a parenteral solution important?