kasceneeds.blogg.se - Visual micro

Visual micro manual#
Visual micro professional#
Visual micro download#

Visual micro download#

Please download our award-winning paper “Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection”, James A. You can also obtain more information from the PDA. Visit our Customer Contact page to enter your e-mail address to download our challenge set brochure.

If you have unknown particles in your defect library, the MML Particle Identification Group can isolate and identify it for you to ensure it is included in your set.

Solution properties such as turbidity, viscosity, or color in hazardous or cytotoxic products must be matched using a placebo or surrogate solution we can design for you.

amber glass) or opacity (syringe barrels or I.V.

A separate set is required for each container type and size: vials, ampoules, syringes.

Once you’ve narrowed the focus and purpose of your set, there are a number of other factors that must be considered as part of designing a set that will provide good data: Usually 3-4 sizes of each contaminant material are produced across the range of POD values determined during system qualification activities. The number of defect units is determined first, and is typically a product of a risk analysis of potential extrinsic, intrinsic, and inherent sources of product or process contamination.

These sets usually contain 10-15% defect units with the remainder comprised of known no-defect or “blank” units. Certified Challenge SetĪ Certified Challenge Set is a 100% customizable qualification set used for on-going training, qualification, and re-qualification of manual, semi-automated, and fully automated inspectors and machines. The number of different sizes can vary, but 6 – 8 different sizes between 50 - 500 µm for particles (fibers are usually larger) is common. A POD set is used for this purpose and is typically comprised of real world particles and also multiple replicates of standard particles, usually glass or polystyrene spheres.

Visual micro manual#

In order to satisfy the USP and regulatory requirements, facilities often turn to the Knapp method to determine their manual performance baseline and qualify the inspection system’s capabilities. Probability of Detection (POD) Sets (Knapp Method) Each container contains a single defect particle in a range of 100µm –1000µm for particles and ≥ 500 µm -2,000 µm for fibers representative of extrinsic and intrinsic contaminants expected to be found at the facility.

This is best accomplished using a set comprised of 15-20 units where most are defect units, along with one or two known no-defect or “blank” units. MML sets can be broken down into three basic categories: Introductory or Training SetsĪ technician new to the science of visual inspection needs to build confidence identifying different materials, usually starting with very large sizes and progressively working smaller toward the limit of detection for visual inspection.

Visual micro professional#

Our Sets are used by injectable pharmaceutical manufacturers and professional organizations world-wide to train and qualify human inspectors and semi- and fully automated inspection machines. Micro Measurement Labs has been manufacturing Challenge Sets for Visual Inspection for nearly 20 years.