Microbiological analysis of cosmetics according to European Pharmacopoeia

Nondestructive 3D analysis of internal structures by X-ray computed tomography. The method visualizes voids, cracks, density, and phase differences within solid structures. The method is most suitable for powdered materials, such as pharmaceutical and cosmetic ingredients. The resolution can go down to 2-3 µm for powders. Please contact us for more information about the analysis options for different materials and material dimensions.

Test of 1 bottle at 20 °C with Malvern Spraytec to characterize particle sizes between 0.1 µm and 900 µm with a standard distance between the nozzle and the laser beam. The results are reported for 3 repeat shots. Particle size distribution histograms, percent finers (Dv10, Dv50, Dv90), and % of particles smaller than 5 µm, 10 µm, and 50 µm are reported. Providing two 100% charge spray bottles per analysis is recommended for aerosols. Contact us for a quote and more information on analyses under nonstandard conditions.

Imaging of the sample with transmission electron microscope (TEM). Typically, several images with varying magnifications are taken to get a good overview of the sample. TEM allows nm-resolution images. Solid samples often require FIB preparation before analysis. HR-TEM can also be provided. Contact us for more details.

Determination of particle size distribution (PSD) by dynamic light scattering (DLS). Analysis can be done from dispersions or solids that can be dispersed in water or organic solvents. The method is suitable for particle sizes from 0.4 nm to 10 µm.

Phase identification and quantification (Rietveld analysis) of a crystalline powder material using X-ray diffraction (XRD). The analysis can also provide unit cell dimensions. The analysis is only suitable for materials with at least one crystalline phase. The quantification accuracy is roughly 0.1 %, depending on the sample matrix and the phase in question. The available temperature range for XRD measurements is 25-1100 °C and the crystallinity can be studied as a function of temperatures. The measurements can be done under a normal atmosphere, inert gas, or vacuum. Please contact our experts to discuss the available temperature and atmosphere combinations. Please mention which crystalline phases your material contains and which ones are you interested in quantifying when requesting testing. However, the method can be applied to unknown phases as well. Either a tabletop or a synchrotron XRD can be used to perform the measurements.

Imaging of the sample using scanning electron microscopy (SEM). Typically, several images are taken with varying magnifications to get a good overview of the sample. Non-conductive samples can be prepared with a metallic coating to allow imaging. For cross-section measurement, additional preparation might be needed: FIB, BIB or freeze fracturing. If compositional analysis is also needed, please see the SEM-EDX measurement.

Imaging of the sample using a scanning electron microscope (SEM) with energy-dispersive X-ray spectroscopy (EDX or EDS). Typically, several images are taken with varying magnifications to get a good overview of the sample. An EDX mapping, line scan, or point measurement is collected to measure the sample composition (elemental at.% or wt.%). Non-conductive samples can be prepared with a metallic coating. For cross-section measurement, additional preparation might be needed: FIB, BIB, or freeze fracturing.

Qualitative or comparative analysis of crystalline powders using X-ray diffraction (XRD). The analysis is only suitable for materials with at least one crystalline phase.

UPLC-MS/MS analysis for determining the melatonin content in dietary supplements. According to Regulation (EU) No 432/2012, melatonin supplements may be marketed with the following health claims: "Melatonin contributes to the alleviation of subjective feelings of jet lag." The claim can be used if the product contains at least 0.5 mg of melatonin per portion., "Melatonin contributes to the reduction of time taken to fall asleep." The claim can be used if the product contains at least 1 mg of melatonin per portion..

We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN 14683 standard. The tests included in the packages are required to label face masks with the CE marking. Medical face masks are divided into Types I and II according to their bacterial filtration efficiency. Type I masks are not intended for healthcare professionals, but for the public to prevent the spread of infectious diseases. Type II masks are further classified based on whether they are splash-resistant (Type IIR) or not (Type II). To comply with the European Standard EN 14683, Type II face masks must undergo the following quality tests: Bacterial filtration efficiency (BFE) - The ability of the face mask to filter the bacterium Staphylococcus aureus. The BFE is expressed as the percentage of colony-forming units (cfu) that have passed via aerosol through the facemask. If a face mask consists of two or more areas with different characteristics, these areas will be tested separately., Breathability (Differential pressure) - The amount of differential pressure required to draw air through a measured surface area at a constant flow rate., Microbial cleanliness (Bioburden) - The measurement of colony forming units per gram as per EN ISO 11737-1., Biocompatibility - The medical face mask manufacturer shall complete a biocompatibility evaluation according to ISO 10993-1 as a surface device with limited contact. The applicable toxicology testing regimen shall also be determined.. In addition to the above, Type IIR masks require the following test: Splash resistance - Performed according to ISO 22609, this test determines the ability of a face mask to resist penetration of splashes of liquid at different pressures.. The lower displayed price applies to the Type II mask test package, while the higher price also includes the splash resistance test required for Type IIR masks.