HPF10

HPF10 is the most controlled perfluorodecalin on the market. Chemical tests of Nuclear Magnetic Resonance (NMR), Fourier Transform Infrared Spectroscopy (FT-IR) and Gas Chromatography (GC) are performed to ensure its safety. The H_value is less than 10 ppm and the perfluorooctanoic acid (PFOA) is absent.

Biological tests of cytotoxicity by direct contact according to ISO 10993-5 are also performed on BALB 3T3 and ARPE-19 cells.

To increase safety, HPF10 was also tested for cytotoxicity in an innovative ex-vivo human retina model.

REF: HPF 003-00; HPF 004-00; HPF 021-00; HPF 022-00 Categories: Ophthalmic surgery, Perfluorocarbons

Description
Additional information

What is HPF10?

HPF10 is high purity perfluorodecalin, sterile and apyrogenic, packaged in prefilled 10 ml glass syringe with Luer Lock, to be used intraoperatively to defold and stabilize the detached retina. The product allows a safe delivery of laser energy and a reduced number of bubbles.

The content of endotoxins is less than 0,2 EU/ml.

HPF10 is a product tested for cytotoxicity on ARPE-19 and BALB 3T3 cells, whose results are shown on the confirmation of use labels inside the package, for a correct information to surgeon and an increased safety for the patient.

DEPLIANT

Depliant HPF_ENG 2.08 MB 1134 downloads

The depliant of the perfluorocarbons. ...

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Clinical use

PERFLUORODECALIN IS INDICATED FOR COMPLEX CASES WITH SUBSEQUENT USE OF SILICONE OIL AS LONG-TERM TAMPONADE

Characteristics

PURE
SAFE
BIOCOMPATIBLE
CHEMICALLY CONTROLLED
CYTOTOXICITY TESTED

Technical Documents

CE Certificate 335.83 KB 3505 downloads

AL.CHI.MI.A. S.R.L. production quality system is compliant with Annex Il (excluding...

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Technical Sheet - HPF 003-00 518.05 KB 413 downloads

HPF10, high purity perfluorodecalin - vial - 1 x 5 ml ...

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Technical Sheet - HPF 004-00 518.01 KB 378 downloads

HPF10, high purity perfluorodecalin - vial - 1 x 7 ml ...

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Technical Sheet - HPF 021-00 518.24 KB 358 downloads

HPF8, high purity perfluorodecalin - syringe - 1 x 5 ml ...

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Technical Sheet - HPF 022-00 518.20 KB 360 downloads

HPF8, high purity perfluorodecalin - syringe - 1 x 7 ml ...

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Surgical Videos

HPF – How to use the HPF syringe

Publications and Presentations

Comparison of Perfluorocarbon Liquids Cytotoxicity Tests: Direct Contact Versus the Test on Liquid Extracts
Year: 2022 Authors: Gatto C.; Ruzza P.; Giurgola L.; Honisch C.; Rossi O.; Romano M. R.; Ragazzi E.; D'Amato Tóthová J. ACS Omega Journal doi/10.1021/acsomega.2c04697 Online version This is a: [...]
Ex vivo evaluation of retinal cytotoxicity after the use of multiple medical devices in pars plana vitrectomy in porcine eyes
Year: 2021 Authors: Gatto C.; Romano M.R.; Giurgola L.; Ferrara M.; Ragazzi E.; D'Amato Tóthová J. Experimental Eye Research 10.1016/j.exer.2021.108837 Online version This is a: Publication This study aimed [...]
Intraocular toxicity caused by MEROCTANE perfluorocarbon liquid
Year: 2021 Authors: Coco-Martin R. M.; Andrés-Iglesias C.; Srivastava G. K.; Lagos-Rodriguez J.; Ruiz-Tevah M.; Díaz-Cárdenas M. R.; Fernandez-Bueno I.; García-Serna J.; García-Gutierrez M. T.; García-Layana A.; Pastor J. C. Sci Rep 11, 599 [...]
Evaluation of Cytotoxicity of Perfluorocarbons for Intraocular Use by Cytotoxicity Test In Vitro in Cell Lines
Year: 2019 Authors: Romano R. M.; Ferrara M.; Gatto C.; Ferrari B.; Giurgola L.; D’Amato Tóthová J. Translational Vision Science & Technology: October 2019, Vol.8, 24 doi:10.1167/tvst.8.5.24 Online version This is a: [...]
H content is not predictive of perfluorocarbon ocular endo-tamponades cytotoxicity in vitro
Year: 2019 Authors: Ruzza P.; Gatto C.; Ragazzi E.; Romano R. M.; Honisch C.; D’Amato Tóthová J. ACS Omega Journal: August 2, 2019 doi.org/10.1021/acsomega.9b01793 Online version This is a: Publication Abstract: In recent years, cases [...]
Cytotoxicity testing according to ISO 10993-5 of perfluorocarbon manufacturing process residuals
Year: 2018, Euretina Authors: Romano M. Co-Authors: Gatto C.; Giurgola L.; Ferrara M.; D'Amato Tóthová J. Methods: Serial dilutions of perfluorooctanoid acid, 1H,1H,7H-dodecafluoro-1- heptanol, 1H,1H,1H,2H,2H-Perfluorooctane, 1H perfluorooctan; ethylbenzene, paraxylene, perfluotobutyfurane, and hexafluoro-1,2,3,4-tetrachlorobutane were tested by [...]
Perfluorocarbons for intraocular use: cytotoxicity test validation study according to ISO 10993-5
Year: 2018, Euretina Authors: Romano M. Co-Authors: Gatto C.; Giurgola L.; Ferrara M.; D'Amato Tóthová J. Methods: BALB3T3 and ARPE19 cell lines were cultured in 96-well plates for direct contact cytotoxicity test of 22%, 59%, [...]
Pars Plana Vitrectomy Alone for the Management of Pseudophakic Rhegmatogenous Retinal Detachment with Only Inferior Breaks
Year: 2016 Authors: Martínez-Castillo V. J.; García-Arumí J.; Boixadera A. Ophthalmology 123(7): 1563-9, 2016 Online version This is a: Publication Purpose: To report the surgical results of primary pseudophakic [...]
Interaction between Perfluorocarbon Liquid and Heavy Silicone Oil: Risk Factor for “Sticky Oil” Formation
Year: 2012 Authors: Romano M.R.; Vallejo-Garcia J.L.; Parmeggiani F.; Vito R.; Vinciguerra P. Curr Eye Res. 37(7): 563-6, 2012 Online version This is a: Publication Abstract: Interactions between perfluoro-n-octane [...]
Ocular tolerance and efficacy of short-term tamponade with double filling of polydimethyloxane and perfluoro-n-octane
Year: 2011 Authors: Zenoni S.; Romano M.R.; Palmieri S.; Comi N.; Fiorentini E.; Fontana P. Clin Ophthalmol. 2011; 5: 443–449 Online version This is a: Publication Abstract: Double filling [...]

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Additional information

Packaging	Syringe, Vial
Items	1
Volume	5 ml, 7 ml

HPF10

What is HPF10?