Perfluo­ro­carbon Liquids

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.

Need to purify PFCL

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.

The H-value Quality Criterion

H-Value

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.

Silicone Oils

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.

Oligo­sil­oxane Content

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.

Viscous Media

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.

  • Hydrogels
  • Hyaluronic acid
  • Deriva­tives of hyaluronic acid
  • Cross-linked hyaluronic acid
  • HPMC
  • Modified HPMC
  • Newtonian and non-Newtonian fluids

Water-based Prepa­ration

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.

  • Approach to “Dedicated Equipment”
  • Individual stirring geometry
  • Estab­lished buffering systems
  • Simul­ta­neous or gradual steri­liz­ation of product and shell

Dosage Forms

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.

Fields of Appli­cation

The products produced at Pharmpur are predo­mi­nantly used in ophthal­mology, ortho­pedics, esthetics and urology.