PharmaCounts™ – Traceable 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.
Product-Series
Traceable particle count controls designed to comply with requirements of the pharmaceutical industry
The PharmaCount™ series by Applied Microspheres product line consists 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. PharmaCount™ series are not suitable for replacing the official standards supplied by the US, Japanese, or Korean Pharmacopeia organisations, but the products mimic the specifications to a particle standard as defined in the pharmaceutical standards. As such, they are ideally suited to perform regular tests to ensure compliancy of the analytical instruments applied in GMP environments. PharmaCount™ products consist of particle size standards traceable to the International System of Units (SI). The Certificates of Traceability supplied with each product meet requirements of GMP-compliant records of instrument validations.
PharmaCount™ 3M/1D | BS-Partikel PC-Series
PharmaCount™ 3M/1D is a series of ready-to-use, monodisperse polymer microsphere suspensions designed for validating optical particle counters. These products offer count controls and size standards referring to a variety of size channels. Their product design leads to eliminating the need for dilution and handling.
The microspheres are composed of polystyrene cross-linked with divinylbenzene (DVB), which has a refractive index of 1,59 at 589 nm and a density of 1,05 g/cm³. The aqueous suspension medium contains a combination of dispersing agents to prevent particle clumping or adhesion to flow surfaces in the particle counter.
PharmaCount™ 3M/1D multi-purpose offers a concentration of 3000 particles per mL in each 25 mL bottle. A magnetic stir bar is included in each bottle for clean, convenient, and direct sampling by instruments.
These products are designed for setting or checking the calibration of channel thresholds or for verifying the count precision of liquid particle counters. Their certified diameters are traceable to SI (International System of Units), which includes state of the art NIST-traceability (National Institute of Standards and Technology of the United States).
PharmaCount™ 3M/1D meets the demanding requirements of contamination control laboratories in modern industries. The applicable product range is listed in the accompanying chart.
There is another line of products called the BS-Partikel PC-Series that serves the same purpose as PharmaCount™ 3M/1D but with a different packaging configuration. The PC-Series products are essentially the same as PharmaCount™ 3M/1D in terms of their composition, properties, and intended use for validating optical particle counters. However, the key difference lies in the way the products are packaged and bundled. While PharmaCount™ 3M/1D comes as a set of 6 individual suspensions, the BS-Partikel PC-Series is offered as a set containing 3 suspensions and 3 blanks.
| Series | Part No. | Nominal Diam. | Nominal Count Rate | Set Content | Volume | Price |
|---|---|---|---|---|---|---|
| 3M | 3M002-25 | 2 µm | 3000/mL | 6 x Suspension | 25 mL each | |
| 3M005-25 | 5 µm | |||||
| 3M010-25 | 10 µm | |||||
| 3M015-25 | 15 µm | |||||
| 3M020-25 | 20 µm | |||||
| 3M025-25 | 25 µm | |||||
| 3M030-25 | 30 µm | |||||
| 3M040-25 | 40 µm | |||||
| 3M070-25 | 70 µm | |||||
| 3M100-25 | 100 µm | |||||
| 1D | 1D025-25 | 25 µm | 500/mL | |||
| 1D040-25 | 40 µm | |||||
| 1D070-25 | 70 µm |
PharmaCount™ US | BS-Partikel PharmaCount™ 1510
PharmaCount™ US meets the requirements of the “U.S. Pharmacopeia <1788.1>: Light Obscuration Method for the Determination of Subvisible Particulate Matter” in injections and ophthalmic solutions. It is intended for use as an intermediate instrument control. Each bottle contains monodisperse polymer microspheres with 15 µm nominal diameter. The acceptance count range and the counts ratio between the population fractions in sizes of ≥ 10 µm and ≥ 15 µm comply with the official standard as provided by the USP. It is supplied in a pack of six 25 mL bottles with a magnetic stir bar included in each bottle to ensure optimal dispersion and uniformity during sampling.
There is another line of products called BS-Partikel PharmaCount™ 1510 that serves the same purpose as PharmaCount™ US. In contrast to PharmaCount™ US the product PharmaCount™ 1510 consists of two particle populations, which leads in a more robust test for regular performance checks. While PharmaCount™ US is exclusively available as a set of 6 Suspensions PharmaCount™ 1510 is available in 2 size options consisting of 1 Suspension and 1 Blank or 3 Suspensions and 3 Blanks.
| Series | Part No. | Nominal Diam. | Nominal Count Rate | Set Content | Volume | Price |
|---|---|---|---|---|---|---|
| US | 20015-25 | 15 µm | according to USP count standard | 6 x Suspension | 25 mL each |
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 United States Pharmacopeia <729>. It is used for instrument control and supplied in packs of six 25 mL bottles. Each bottle contains two different size populations of monodisperse polymer microspheres with nominal diameters of 5 µm and 10 µm, with approximate counts of 400.000 and 200.000 / mL, respectively. Particle diameters are traceable to SI, which includes NIST traceability. A magnetic stir bar is included in each bottle to ensure optimal dispersion and uniformity during sampling.
| Series | Part No. | Nominal Diam. | Set Content | Volume | Price |
|---|---|---|---|---|---|
| BC | 20510-25 | 5 µm, 10 µm | 6 x Suspension | 25 mL each |
PharmaCount™ TC
PharmaCount™ TC is a particle size and count reference standard designed to easily calibrate single particle optical sizing (SPOS) instruments using light extinction and/or scattering. It is supplied in a pack of six 25 mL bottles. Each bottle contains three different size populations, monodisperse polymer microspheres with nominal diameters of 0,8 µm, 2 µm and 5 µm, with approximate counts of 1.200.000 / mL, 800.000 / mL, and 400.000 / mL, respectively. Particle diameters are traceable to SI, which includes NIST traceability. A magnetic stir bar is included in each bottle for optimal dispersion and uniformity during sampling.
| Series | Part No. | Nominal Diam. | Set Content | Volume | Price |
|---|---|---|---|---|---|
| TC | 20825-25 | 0,8 µm, 2 µm, 5 µm | 6 x Suspension | 25 mL each |
PharmaCount™ JPKP
PharmaCount™ JPKP meets the requirements of the Japanese and Korean pharmacopeia insoluble particulate matter tests for injections. It is meant to be used as an instrument control for the test prescribed by the Japanese and Korean Pharmacopeia. The tests are supplied in a pack of two 50 mL bottles. Each bottle contains 763-1155 particles / mL of monodisperse polystyrene microspheres with a 10 µm calibrated mean diameter. A magnetic stir bar is included in each bottle to ensure optimal dispersion and uniformity during sampling.
| Series | Part No. | Mean Dia. | Set Content | Volume | Price |
|---|---|---|---|---|---|
| JPKP | 20010-50 | 10 µm | 2 x Suspension | 50 mL each |
