• 粒子計數標準品

粒子計數標準品

粒子計數標準品是一種懸浮液,內含 (NIST 可追溯) 顆粒,並具有精確定義的每毫升顆粒數。它們可用於污染控制應用中的液體粒子計數器監測,例如半導體無塵室。該產品系列包括 3K4K 系列、Pharm-Trol™、Ezy-Cal™ 和 Thermo Scientific 的 Count-Cal™ 系列。

這些粒子計數控制標準品專為幫助製藥 QC 實驗室的液體粒子計數器監測而設計,適用於符合美國、歐洲、日本或韓國藥典 (Pharmacopeia) 法規的應用。其中,PharmaCount™ 系列包含一套專為 Accusizer 儀器設計的標準品,可用於簡化校正程序,而 Accusizer 儀器在製藥環境中被廣泛使用。

1.    3K/4K Series Particle Counter Standards

Ensure accurate and convenient calibration of laser particle counters with Thermo Scientific™ 3K/4K Series Particle Counter Standards. Compared with our 3000 and 4000 Series products, this product line is precisely diluted for immediate use in laser particle counters with minimal time-consuming concentration adjustments.

Features:

·    Suspensions of monodisperse polystyrene spheres for use in airborne or liquid particle dispersion systems

·    Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology (NIST)

·    Accurately calibrates or checks performance of laser particle counters used in cleanrooms and other contamination monitoring applications

·    Particles prepared as low residue aqueous suspensions for minimal background interference

Nominal Diameter

Bottle Size

Concentration

3K Particle Counter Standards

0.10 µm

15 mL

1 x 109/mL

0.15 µm

15 mL

1 x 109/mL

0.20 µm

15 mL

1 x 109/mL

0.22 µm

15 mL

1 x 109/mL

0.27 µm

15 mL

1 x 109/mL

0.30 µm

15 mL

1 x 109/mL

0.35 µm

15 mL

1 x 109/mL

0.40 µm

15 mL

1 x 109/mL

0.50 µm

15 mL

1 x 109/mL

0.60 µm

15 mL

1 x 109/mL

0.70 µm

15 mL

1 x 109/mL

0.80 µm

15 mL

1 x 109/mL

0.90 µm

15 mL

1 x 109/mL

0.99 µm

15 mL

1 x 109/mL

1.00 µm

15 mL

1 x 109/mL

1.60 µm

15 mL

1 x 109/mL

4K Particle Counter Standards

2.0 µm

15 mL

5 x 108/mL

3.0 µm

15 mL

5 x 107/mL

4.0 µm

15 mL

5 x 107/mL

5.0 µm

15 mL

1 x 107/mL

6.0 µm

15 mL

1 x 107/mL

7.0 µm

15 mL

1 x 107/mL

10 µm

15 mL

1 x 106/mL

15 µm

15 mL

1 x 106/mL

20 µm

15 mL

3 x 105/mL

25 µm

15 mL

3 x 105/mL

30 µm

15 mL

3 x 105/mL

40 µm

15 mL

8 x 104/mL

50 µm

15 mL

8 x 104/mL

60 µm

15 mL

8 x 104/mL

70 µm

15 mL

8 x 104/mL

80 µm

15 mL

3 x 104/mL

100 µm

15 mL

3 x 104/mL

2.    Ezy-Cal Count Precision Standards

Meet the unique and demanding requirements of the contamination control laboratory in modern industries with Thermo Scientific™ Ezy-Cal™ Count Precision Size Standards, easy-to-use liquid particle count controls at 2000 particles per mL. Designed for regular use in liquid particle counters to verify instrument calibration before each use, standards assure reproducibility of the particle counter by permitting a continuous record of its performance using a NIST™-traceable microsphere suspension with a precise concentration.

Features:

·    Ready-to-use (no dilution required) particle size standard for validating optical particle counters

·    Magnetic stir bar included in each bottle for clean, convenient and direct sampling

·    Aqueous suspension medium contains a combination of dispersing agents to keep particles from clumping or sticking to flow surfaces in the particle counter

·    Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology

Recommended for:

Checking the calibration of liquid particle counters.

Nominal Diameter

Bottle Size

Concentration

2 µm

100 mL

2000 particles/mL ± 10%

5 µm

100 mL

2000 particles/mL ± 10%

10 µm

100 mL

2000 particles/mL ± 10%

15 µm

100 mL

2000 particles/mL ± 10%

20 µm

100 mL

2000 particles/mL ± 10%

25 µm

100 mL

2000 particles/mL ± 10%

30 µm

100 mL

2000 particles/mL ± 10%

50 µm

100 mL

2000 particles/mL ± 10%

70 µm

100 mL

2000 particles/mL ± 10%

3.    COUNT-CAL Count Precision Standards

Minimize contamination by eliminating the need for serial dilutions and extensive sample handling with Thermo Scientific™ COUNT-CAL™ Count Precision Size Standards, a cost-effective, convenient and easy to use product for validating liquid particle counters. Packaged in single-use bottles and intended to be sampled directly from the bottle, standards were developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP 788 and 789 (Particulate Matter in Injections and Particulate Matter in Ophthalmic Solutions).

Ready to use precision size standards are designed for regular use in liquid particle counters to verify instrument calibration before each use, assuring the reproducibility of the particle counter by permitting a continuous record of its performance using a NIST™ traceable microsphere suspension with a precise concentration.

·    Polystyrene microspheres are suspended in an ultra clean diluent

·    Concentration is optimized for use in light obscuration particle counters and other low concentration counting applications

·    Diameters are traceable to the Standard Meter through the National Institute of Standards and Technology (NIST)

·    CC10 and CC25 are ideal for USP 788 and 788 interim testing

Includes:

·    Certificate of Calibration and Traceability to NIST™

·    Particle counting protocol

·    Material Safety Data Sheet

Nominal Diameter

Bottle Size

Concentration

2 µm

6 x 25 mL

3000 particles/mL ± 10%

5 µm

6 x 25 mL

3000 particles/mL ± 10%

10 µm

6 x 25 mL

3000 particles/mL ± 10%

15 µm

6 x 25 mL

3000 particles/mL ± 10%

20 µm

6 x 25 mL

3000 particles/mL ± 10%

25 µm

6 x 25 mL

3000 particles/mL ± 10%

30 µm

6 x 25 mL

3000 particles/mL ± 10%

50 µm

6 x 25 mL

3000 particles/mL ± 10%

70 µm

6 x 25 mL

3000 particles/mL ± 10%

4.    Validex Count Precision Standards

Validate the performance of liquid particle counters with Thermo Scientific™ Validex™ Count Precision Size Standards. Excellent for instrument calibration and verification in the drinking water industry and for low level liquid particle counting and calibration, standards contain NIST™-traceable polymer particles packaged in ultrapure water at concentrations ideal for use in validating the performance of liquid particle counters.

Particle counting in the drinking water industry has rapidly become an indispensable technology for optimizing water quality. The majority of particle counters used in the drinking water industry operate on the principle of single particle light obscuration.

Features:

·    Composition of suspension optimized to promote dispersion of particles

·    Contains 500mL of suspension at a nominal concentration of 1000 particles per mL

·    Stir bar included in the bottle to aid dispersion

·    Certified concentration

·    Ultraclean diluent

·    No dilution required

·    Sample directly from bottle to avoid contamination

·    Larger volume for appropriate testing

Nominal Diameter

Bottle Size

Concentration

5 µm

500 mL

1000 particles/mL ± 10%

10 µm

500 mL

1000 particles/mL ± 10%

5.    Pharm Count Precision Standards

Document the reproducibility of a particle counter by permitting a continuous record of its performance with Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards, ready-to-use precision standards designed for regular use in liquid particle counters for USP <788> and <789> verification. Data is documented for internal or customer audits by using a NIST™-traceable microsphere suspension with a known concentration.

Features:

·    Contains NIST™-traceable size standards with a measured particle count

·    Developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP <788> and <789> verification (Particulate Matter in Injections and Particulate Matter in Opthalmic Solutions)

·    Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology

·    Prepared with the same exacting procedures as the USP Count Reference Standard, providing process control data for particle counting consistency and verification of size calibration

Nominal Diameter

Bottle Size

Concentration

15 µm

6 x 25 mL

3800 particles/mL ± 15%

15 µm

20 x 25 mL

3800 particles/mL ± 15%



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