PharmaCounts™ Traceable Particle Count Controls
PharmaCounts™ Traceable Particle Count Controls are a range of Traceable Particle Standards consisting of polystyrene particle suspensions with precisely defined particle numbers. Designed for pharmaceutical quality control laboratories, PharmaCounts™ Traceable Particle Count Controls facilitate Liquid Particle Counter Calibration and Liquid Particle Counter Validation while supporting compliance with pharmacopeial requirements.
The product line is supplied with particle size standards traceable to the International System of Units (SI) and includes Certificates of Traceability suitable for GMP Instrument Validation records. The precisely defined particle concentrations provide reliable and repeatable performance for routine instrument calibration, intermediate instrument verification and ongoing quality control.
PharmaCounts™ Traceable Particle Count Controls support USP Particle Testing and EP Particle Testing by providing Traceable Particle Standards suitable for the calibration, validation and performance verification of liquid particle counters used in regulated pharmaceutical environments. The SI-traceable particle standards help laboratories maintain accurate measurements while supporting compliance with pharmacopeial requirements.
Designed for routine Liquid Particle Counter Calibration, system suitability testing and instrument performance verification, PharmaCounts™ Traceable Particle Count Controls deliver dependable, reproducible and traceable results for pharmaceutical manufacturing, quality assurance and quality control laboratories.
Applications and Usage
| ✔ Calibration of liquid particle counters | ✔ Pharmaceutical quality control laboratories |
| ✔ Validation of liquid particle counters | ✔ Support for compliance with US, European, Japanese and Korean pharmacopeial requirements |
| ✔ Intermediate instrument control and performance verification |
| Parameter | Specification |
|---|---|
| Series | 3M |
| Nominal Diameter Range | 2 µm – 100 µm |
| Available Sizes | 2, 5, 10, 15, 20, 25, 30, 40, 50, 70, 100 µm |
| Nominal Count Rate | 3000 particles/mL |
| Set Content | 6 particle suspensions |
| Volume | 25 mL each |
| Application | Calibration and validation of particle counters |
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Frequently Asked Questions
What are PharmaCounts™ Traceable Particle Count Controls?
They are SI-traceable particle suspensions used for Liquid Particle Counter Calibration and Liquid Particle Counter Validation in pharmaceutical quality control laboratories.
Why is Liquid Particle Counter Calibration important?
It ensures accurate particle counting, reliable instrument performance and regulatory compliance.
How do PharmaCounts™ support GMP Instrument Validation?
They provide Traceable Particle Standards for calibration, verification and documented validation records.
Can PharmaCounts™ be used for USP Particle Testing and EP Particle Testing?
Yes. They are designed to support both USP Particle Testing and EP Particle Testing for pharmacopoeial compliance.
What are Traceable Particle Standards?
Certified reference materials with documented traceability used to ensure accurate calibration and validation.
Which industries use PharmaCounts™ Traceable Particle Count Controls?
Pharmaceutical manufacturers, biotechnology companies, research laboratories and quality control laboratories.