Jordan Saavalainen

Determination of osmolarity of liquid samples using a freezing point osmometer according to the European Pharmacopoeia method Ph. Eur 2.2.35. Osmolarity is defined as the number of osmols per liter of liquid, reflecting the total number of dissolved ionic and molecular substances present in the solution in molarity. The results of the analysis are reported in mOsm/L. NOTE: The total concentration of the solute in the product needs to be provided (expressed in g/mL), as this information is necessary for the calculation of osmolarity. Without this information, only the product's osmolality (mOsm/kg) can be determined. If the product is a powder, please provide instructions for the preparation of the solution. Analysis can also be performed under GMP - please ask us for an offer.

The osmolality of liquid samples is determined using a freezing point osmometer according to the Ph. Eur 2.2.35 or USP <785> method. Osmolality is the number of osmols per kilogram of liquid, and it reflects the total number of dissolved ionic and molecular compounds present in a kilogram of solution. The results of the analysis are reported in mOsm/kg. The analysis includes the determination of relative density, as the value is necessary to calculate osmolality. NOTE: If the product is in powder form, please provide instructions for preparing the solution. Analysis can also be performed under GMP - ask for an offer from our experts.

Chemical characterization according to the ISO 10993-18 standard is performed to identify the constituents of a medical device and to estimate and control the risks associated with its chemical composition. The test is a key part of assessing the biocompatibility of medical devices. Chemical characterization includes the estimation of substances released under simulated or exaggerated laboratory conditions (extractables) or the detection of actually released substances (leachables) by the medical device during clinical use. Applicable methods may include HS-GC (volatile organic compounds), GC-MS (semi-volatile organic compounds), LC-MS (non-volatile organic compounds), and ICP-MS (inorganic elements). Suitable tests, solvents, and analysis methods are chosen according to the device's composition, intended contact time, and site. Any chemicals detected above concentrations established to be safe require further evaluation, typically through a toxicological risk assessment (ISO 10993-17). We provide a range of chemical characterization tests customized to the product, the intended market area (MDR, FDA), and quality requirements (GLP, accreditation). The starting price is based on the chemical characterization of volatile organic compounds (GLP, FDA).

ASTM D4169 outlines test methods to simulate the stresses that shipping containers may encounter during handling, storage, and transportation. The standard is typically followed in the medical device industry to evaluate the ability of the outer packaging to protect the sterile barrier system (SBS), which in turn protects the enclosed device from microbial contamination. Some of the key tests covered by ASTM D4169 include: Drop testing, Vehicle stacking, Vibration testing, Pressure testing, Concentrated impact, Climatic conditioning. We are happy to prepare a custom offer for distribution testing, accounting for your packaging system's expected distribution environment, level of protection required, and the modes of transport used (air, land, and sea). Do not hesitate to request a quote using the form below.