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Standards
Micro Measurement Labs: Leaders in Visual Inspection Sets
Micro Measurement Labs has been at the forefront of manufacturing challenge sets for visual inspection for more than two decades. Our sets are trusted by injectable pharmaceutical manufacturers and professional organizations worldwide to train and qualify human inspectors, as well as semi-automated and fully automated inspection machines. Our team has the expertise to work with any container configuration, including feasibility testing and developing new methods for new product designs.
Customized for your product: new product and container development assistance and cost-effective mimic solutions. With comprehensive configurations available, you can design your own kit with guidance from our experts to ensure it meets all regulatory standards.
Our sets are fully customizable to support ongoing training, qualification, and re-qualification of manual, semi-automated, and fully automated inspectors and machines.
Introductory / Training Sets
Designed for technicians new to visual inspection, these sets help build confidence in identifying different materials. Starting with larger sizes and progressively working towards the limit of detection, each set typically includes about 20 units, mostly defect units, along with one or two known no-defect or “blank” units. Each container holds a single defect particle ranging from 100µm to 1000µm for particles and 500µm to 2000µm for fibers, representing common contaminants.
Probability of Detection (POD) Sets
To meet USP <790> and <1790> regulatory requirements, facilities often turn to the Knapp method to establish a manual performance baseline and qualify inspection systems. Our POD sets, which typically contain 10-15% defect units determined through a risk analysis of potential contamination sources, are designed to meet these needs. Each set includes real-world particles and multiple replicates of standard particles, with 6-8 different sizes ranging from 100-500µm for particles and fibers starting at 500µm.
Particle Count/Size Standards
Micro Measurement Labs offers Particle Size and Count Standards in two main categories:
Instrument Performance Qualification Check (PQ) Standards
PQ Standards are essential tools for lab managers who need to verify their instruments’ accuracy between manufacturer calibrations and field service visits. We offer single size and multi-modal standards certified for concentration (#/mL) in polystyrene latex (PSL) spheres.
Standards Designed for Specific Regulatory Tests
Standards designed for specific regulatory tests are specifically designed to meet lot release and regulatory chapter requirements, including USP Chapters <729>, <787>, <788>, <789>, and <1788>.
