meet usp regulations - thermo fisher...
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meet USP regulations
Cyto Cal Flow Cytometry Calibration and Setup Particles Increase throughput and precision
Particle Solutions for USP <729>, <788> and <1027>
Ensuring optimal particle counter, sizer and flow cytometer instrument performance is crucial to your product development and ability to comply with ISO and USP <729>, <788> and <1027> regulations. With our uniform, NIST traceable size standards, count controls, calibration and set-up particles, you can• calibrate to ensure the lasers and optics are performing precisely• align to make sure the laser and flow cell is focused• count for absolute cell counting• make sure the instrument is sizing and measuring properlyAs a result, you can be confident your instruments are consistently delivering the precise and accurate data you require for USP compliance.
measure properly
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USP Number
USP Section Title/Requirement
USP Particle Requirement
Particle Instrument
Measurement Method Technique Thermo Scientific
Particle: Cat. Number
729
Globule size distribution in lipid injectable emulsions / Method 1-Light Scattering
100, 250 and 400 nm Particle sizer PCS / QELS Sizing 3000 Series Size Standards: • 3100A • 3240A • 3400A
788
Particulate matter in injections / Method 1-Light obscuration particle count test
Particles of known size between 10 µm and 25 µm with a count < 6000 per container ≥ 10 µm and < 600 per container ≥ 25 µm Test 1b - <100 mL
Particle counter
Light scatter, laser scatter, light blockage
Counting Pharm-trol Count Controls: • CS-BX • CS-PK
1027
Flow cytometry / Instrument set-up
Standardizing PMT Flow cytometer Laser scatter, fluorescence scatter
Counting Cyto-Cal Multifluor + Violet Intensity Calibrator: • FC3MV
1027Flow cytometry / Cell enumeration
Standardizing cell count
Flow cytometer Laser scatter, fluorescence scatter
Counting Cyto-Cal Absolute Count Control: • FC7
1027
Flow cytometry / Quality and Standardization (Standards)
Type I - Alignment standards
Flow cytometer Laser scatter, fluorescence scatter
Counting Cyto-Cal 488 and 633 Alignment Particles: • FA30 • FA3R
1027
Flow cytometry / Quality and Standardization (Standards)
Type II - Reference beads
Flow cytometer Laser scatter, fluorescence scatter
Counting Cyto-Cal Multifluor + Violet Intensity Calibrator: • FC3MV
1027
Flow cytometry/Flow Cytometry applications for cellular samples and cell therapy products
Bead-based immunoassays
Flow cytometer Laser scatter, fluorescence scatter
Counting Cyto-Plex Carboxylated Particles: • FMCR01-12 • FM5CR01-12
35+ years of expertise
The chart below shows recommended particles for optimizing instrument performance in accordance with specific USP regulations.
Count ControlsParticles for calibrating and checking particle counter performance and validating results. For more information, request PF1004.1 brochure or visit website.
NIST Traceable Size StandardsParticles for developing, standardizing and validating particle counting and sizing instruments. For more information, request PF1004.1 brochure or visit website.
Rigorous QC standards
Particles for USP Regulatory Compliance
About the USP
The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. In 2007, the USP, European Pharmacopoeia (Ph. Eur) and Japan Pharmacopoeia (JP) harmonized the <788> methods, definitions and limits.
Flow Cytometry ParticlesParticles for calibrating and set, alignment, and absolute cell counting of all makes and brands of flow cytometers. For more information, request PF4001.1 brochure or visit website.