Perfluorocarbon liquids (PFCLs) are organic compounds in which all H-atoms are replaced by F-atoms. Due to the F-atoms’ electronic structure and arrangement, an almost-complete shield of the molecules is achieved. The compounds are chemically inert. With their low surface tension, low conductivity and high density, their highly solvent properties for gases (oxygen and carbon dioxide) make PFCLs very suitable for different medical applications.
Due to the manufacturing process, perfluorocarbon liquids (PFCL) contain incompletely fluorinated particles and fluoric olefins that are toxic. The toxicity level depends on the compounds’ structure, and is dose-dependent.
Pharmpur conducts a specific, individual purification process for each PFCL, and the success of each procedural stage is analytically controlled.
Impurities in PFCL that have been incompletely fluorinated can be quantified as the source of toxic side effects via the H-value. The elimination of residual protons in the form of HF is enacted via strong chemical bases, and the amount of separated fluoride is determined. Finally, it is back-calculated to the reaction’s origin – the proton concentration. The threshold value for safe application of PFCL is 10 ppm.
Silicones and silicone oils are widely used in medicine. For direct implantation, e.g. when used for ocular endotamponades, an especially high degree of purity is required. Impurities originating during production, such as residual OH-groups (incomplete endcapping), ionic compounds (catalysts) and oligosiloxanes are only tolerable in the trace range. This is ensured by a special method developed by Pharmpur.
Oligosiloxanes are low-molecular components of silicone oil that are generated during the production process. Because of their toxic properties and high susceptibility to diffusing into surrounding tissue, these components must be removed before being administered as an ocular endotamponade. This is ensured by a special method developed by Pharmpur.
Pharmpur produces various gel-like substances with very different rheological properties that are characterised by very low endotoxin content. The production of these products is continuously controlled via rheological analyses. For classifying the products used in ophthalmology, an individual concept was developed based on rheologically-measured values.
Pharmpur specialises in producing and processing water-based preparations applied in a sterile environment. As a rule, these are mixtures of active substances and adjuvants in buffering systems. All processes until terminal sterilisation takes place in the clean room.
Pharmpur produces medicinal and medical products that are filled in syringes, capsules or vials. The shell sterility of the products is safeguarded through sterile bags and/or blister packs.
The products produced at Pharmpur are predominantly used in ophthalmology, orthopedics, esthetics and urology.
