What is visual inspection in pharmaceutical industry?
Table of Contents
What is visual inspection in pharmaceutical industry?
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 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.
What is visual inspection process?
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 visual inspection standard?
Policy: Visual Inspection Standards (VIS) provide relaxations from the surface condition (normally flawless) implied by engineering drawings. Only those relaxations (called imperfections) allowed by this VIS, or the engineering drawing are permitted on parts to which this VIS is assigned.
What is the purpose of visual inspection for injectable products?
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.
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.
What is the purpose of visual inspection?
Visual inspection is commonly used in both manufacturing tasks and non- production environments. In manufacturing tasks, the purpose is to verify that a product is free of defects before installation in the next level of assembly or final distribution to the customer.
Why is visual inspection of a parenteral solution important?
What is the importance of visual inspection?
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.
How do you evaluate parenteral products?
Evaluation of Parenteral Preparations
- Sterility test. Membrane filter method. Direct inoculation method.
- Pyrogen test. LAL Test. In vivo Rabbit test.
- Clarity test/Foreign particulate matter test.
- Leakage test.
- Isotonicity.
- Content uniformity & Weight.
- Extractable Volume.
What are the factors affecting visual inspection?
These are the inspector’s visual acuity, the work-place lighting conditions, the time available for inspection and the provision of feedback or knowledge of results to the inspector.
Why visual testing is required?
Visual Testing, sometimes called automated UI testing or visual regression testing verifies software from a purely visual standpoint. It verifies the aesthetic accuracy of everything end-users see and interact with.
What are the advantages & limitations of visual inspection?
Visual Inspection NDT techniques rely on the aided and unaided eye for the purpose of inspecting a part. VT is the most common testing method used across all industries….Disadvantages of Visual Inspection Techniques:
- Surface indications only.
- Generally only able to detect large flaws.
- Possible misinterpretation of flaws.
What are the five quality control test for parenterals?
1) Sterility Tests. 2) Pyrogen Tests. 3) Leaker Tests. 4) Particulate matter testing.
Why is visual inspection of parenteral solutions important?
What is purpose of visual inspection?
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.
Should the USP develop a new chapter on visual drug inspections?
Pharmaceutical industry officials have proposed the United States Pharmacopeia (USP) develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps. This chapter would be developed with input from the European Pharmacopeia and the Japanese Pharmacopeia.
What is the USP general chapter for visible particulates in injectables?
63 6See USP General Chapter <790> Visible Particulates in Injections, which describes inspection procedures used to demonstrate that injectable products are essentially free from particulates, and USP General Chapter <1790>, an informational chapter that provides recommendations on inspection programs for visible particulates covering the
What is the visual inspection process?
The visual inspection process is the final step in this scenario to ensure finished products in the marketplace are particle free.USP Chapter <1790> includes a critical requirement to qualify the visual inspection system and demonstrate the consistency of inspection processes throughout the product life cycle. 2
Why do we use visual inspection in parenteral products?
It can be used in initial and periodic qualification of visual inspectors. Because the core principle of visual inspection in parenteral products is the same for both manual and automated processes, this method can be extended to automated or semiautomated visual inspection systems as well.
