PharmaCount™ series - Particle Count Controls
PharmaCount™ count controls are designed to facilitate the control of liquid particle counters in pharmaceutical QC laboratories that need to comply with US, European, Japanese or Korean Pharmacopiea regulations.
Particle count and size reference standards
The PharmaCount™ series by Applied Microspheres is a product line consisting of polystyrene particle suspensions with precisely defined numbers of particles. It is designed for pharmaceutical quality control laboratories to facilitate calibration and validation processes for liquid particle counters. Laboratories observing QC protocols meeting the US, EU, Japanese and Korean Pharmacopeia requirements, are obliged to use standards supplied or defined by the US, EU, Japanese or Korean Pharmacopeia organisations to perform mandatory (6 monthly) tests.
Particles used for all PharmaCount ™ series products are traceable to the International System of Units (SI), including NIST. All particle sizing and counting instruments used for the production of the PharmaCount™ series of products are calibrated with reference standards certified by an ISO 17025 accredited laboratory and NIST traceable size standards.
PharmaCount™ US, Pharma-Count™ JP and PharmaCount™ BC meet the specifications of these standards and are therefore ideally suited to perform (intermediate) tests to ensure that their instruments are always correctly calibrated, thereby safeguarding USP, EU, JP and KP compliancy.
In addition, PharmaCount™ BC and PharmaCount™ TC are particle count control products that are specially designed to simplify the calibration of single particle optical sizing (SPOS) instruments, using light extinction and/or scattering, such as Accusizer instruments. These instruments are commonly used in pharmaceutical quality control laboratories and calibration can be troublesome. PharmaCount™ BC and PharmaCount™ TC shorten these time consuming procedures.
PharmaCount™ US
PharmaCount™ US meets the requirements of U.S. Pharmacopeia,
USP 1788 for the determination of Particulate Matter in Injections
and Ophthalmic solutions light obscuration particle count test.
It is designed for use as intermediate instrument control. It is supplied
in a pack of six 25mL bottles. Each bottle contains approx.
3700 particles per ml of monodisperse polymer microspheres with
15 μm nominal diameters for the purpose of obtaining a ratio
between the population fractions with size > 10 μm and > 15 μm.
The provided ratio falls in the range stipulated by USP 1788.
A magnetic stir bar is included in each bottle to ensure optimal
dispersion and uniformity during sampling.
PharmaCount™ JPKP
PharmaCount™ JPKP meets the requirements of Japanese and Korean Pharmacopeia for the determination of Particulate Matter in Injections and Ophthalmic solutions light obscuration particle count test. It is designed for use as instrument control. It is also suitable as intermediate control for the test prescribed by the Japanese and Korean Pharmacopeia. It is supplied in a pack of two 50 mL bottles. Each bottle contains 1000 particles per ml (+/- 10%), of monodisperse polymer microspheres with calibrated mean diameters of 10 μm. A magnetic stir bar is included in each bottle to ensure optimal dispersion and uniformity during sampling.
PharmaCount™ BC
PharmaCount™ BC is a particle size and count reference standard ideally suited for performing insoluble particulate matter tests for lipid injectable emulsions as prescribed by the United States
Pharmacopeia USP 729. It is designed for use as instrument control and supplied in packs of six 25 ml bottles. Each bottle contains two different size populations of NIST traceable monodisperse polymer microspheres with nominal diameters of 5 μm and 10 μm, with approximate counts of 400.000 and 200.000 particles per ml respectively. A magnetic stir bar is included in each bottle to ensure optimal dispersion and uniformity during sampling.
PharmaCount™ TC
PharmaCount™ TC is a particle size and count reference standard designed for easy calibration of single particle optical sizing (SPOS) instruments using light extinction and/or scattering. It is supplied
in a packs of six 25 ml bottles. Each bottle contains three different size populations of NIST traceable monodisperse polymer microspheres with nominal diameters of 0,8 μm, 2 μm and 5 μm, with approximate counts per ml of 1.200.000, 800.000 and 400.000 respectively. A magnetic stir bar is included in each bottle for optimal dispersion and uniformity during sampling.
PharmaCount™ 2M/3M
PharmaCount 2M/3M multi purpose offers a series of ready-to-use more large sized count controls and size standards for validating optical particle counters with no dilution and handling. The products are suspensions of monodisperse polymer microspheres in water with a concentration of 2000 particles per mL. A magnetic stir bar is included in each bottle for clean, convenient and direct sampling by instruments.
PharmaCount 2M/3M is provided for setting or checking the calibration of channel thresholds or for checking the count precision of liquid-borne particle counters. Their certified diameters are traceable to NIST and SI. They are packaged as 100mL screw-cap bottles, sufficient for various calibration procedures on most counters.
The microspheres are composed of polystyrene cross linked by DVB, which has an index of refraction of 1.59 @ 589nm and a density of 1.05 g/cm3. The aqueous suspension medium contains a combination of dispersing agents, which help to keep the particles from clumping or sticking to flow surfaces in the particle counter.
This PharmaCount 2M/3M product line meets all of the unique and demanding requirements of the contamination control laboratory in modern industries. The products are listed in the applicable chart.
