stream 17-Nov-2017. Visual Inspection of Injections To learn the basics of particles, take a look at our introductory course in the Learning Center called Particle 101: Introduction to Particles for the Parenteral Drug Packaging and Delivery Industry; for an in-depth look at the results from the PDA sponsored Stopper Analytical Test Method Qualification Strategy sub-team, see this presentation from 2020 PDA Europe in Basel, Switzerland: Quantifying Loose Particles on Elastomeric Components. The Sub-chapter 4.2.1 aims at avoiding of intrinsic particles already in product development - e.g. approach for the fundamentals of inspection The test procedures follow Chapter <788> guidance. text-align: left; } strOrderUrl = marked_all[0]; This Chapter provides the following particulate matter classifications: extrinsic (foreign contamination), intrinsic (resulting from insufficient cleaning or formulation instability), and inherent (formulation components). and created the Visual Inspection Forum to defect control practices across companies. 4350 East West Highway, Suite 600 effective in August 2017. Consider attending to } border-top: 1px inset #FF0000; The particulate level limits for Methods 1 and 2 according to Chapter <787> are described below: Ophthalmic drug products should be essentially free from particulates that can be observed on visual inspection.