PERFLUOROCARBONS

safety
NO COMPROMISE
ON
CERTIFIED
SAFETY

HPF8 and HPF10 are Alchimia’s perfluoro-n-octane and

perfluorodecalin for intraoperative use, used to defold
and stabilize the detached retina during vitreoretinal
surgery.
Both products undergo Nuclear Magnetic Resonance
(NMR), Fourier-Transform Infrared Spectroscopy
(FTIR) and Gas Chromatography (GC) analytical tests.
The biological safety of HPF8 and HPF10 is also
confirmed by direct contact cytotoxicity tests
according to ISO 10993-5:2009.

After the use of perfluoro-n-octane HPF8, long-term

tamponade with ophthalmic gas is indicated.
The use of perfluorodecalin HPF10 is particularly
suitable for severe cases of retinal detachment
with the subsequent use of silicone oil as long-term
tamponade.
TOTO
Y
XI
- C

CIT

HPF8 HPF10
ED

100% fluorinated 100% fluorinated

INGREDIENT
perfluoro-n-octane perfluorodecalin Y
TEST
BACTERIAL ENDOTOXINS < 0.2 EU/ml

SHELF LIFE 36 months

HPF 001-00 / HPF 002-00 HPF 003-00 / HPF 004-00

REFERENCES
HPF 019-00 / HPF 020-00 HPF 021-00 / HPF 022-00

syringe or vial (5 or 7 ml each) + 1 package insert +

CONTENTS
labels
 BIOLOGICAL ANALYSIS
IN ORDER TO OFFER MORE GUARANTEES AND TO ADDRESS TO THE
GROWING NEED FOR CONTROLLED AND SAFE PRODUCTS ON THE
MARKET, HPF8 AND HPF10 ARE TESTED FOR CYTOTOXICITY ON ARPE-19
AND BALB/3T3 CELLS.

PHYSICO-CHEMICAL ANALYSIS
THE SAFETY OF HPF8 AND HPF10 IS CONFIRMED BY A WIDE RANGE OF PHYSICO-
CHEMICAL ANALYSES TO DETERMINE THE PRESENCE OF TOXIC RESIDUES,
UNFLUORINATED COMPOUNDS (H-VALUE) AND PERFLUOROOCTANOIC ACID
(PFOA). WE ALSO ANALYSE THE SPECTRA OF THE COMPOUNDS AND PURITY.

PERFLUOROCARBONS
HPF8 AND HPF10 ARE ALCHIMIA’S PERFLUORO-N-OCTANE AND PERFLUORODECALIN
FOR INTRAOCULAR TAMPONADE IN VITREORETINAL SURGERY.

SIZES, 5 AND 7 ML
IN ORDER TO MEET THE SURGEON’S NEEDS, HPF8 AND HPF10 ARE AVAILABLE IN 5 AND
7 ML VIALS AND PREFILLED GLASS SYRINGES. THE PRODUCTS ARE PACKED IN A STERILE
POUCH TO MEET GMP REQUIREMENTS.

SAFE PRODUCTS TO CHOOSE

HPF8 AND HPF10 ARE HIGHLY SAFE, CONTROLLED MEDICAL DEVICES. CHOOSE SAFETY,
CHOOSE ALCHIMIA’S PERFLUOROCARBONS!

WHY CYTOTOXICITY TESTS ARE IMPORTANT

ALCHIMIA PERFORMS BIOLOGICAL CYTOTOXICITY TESTING ON BALB/3T3 AND ARPE-19 CELL LINES TO INVESTIGATE
THE BIOLOGICAL EFFECT OF HPF8 AND HPF10. THE TEST THAT IS CARRIED OUT IN COMPLIANCE WITH ISO 10993-5,
IS PART OF A LARGE FAMILY OF BIOCOMPATIBILITY TESTS FOR THE BIOLOGICAL EVALUATION OF MEDICAL DEVICES
ACCORDING TO ISO 10993-1.
THIS FAMILY OF TESTS REQUIRES HPF8 AND HPF10 TO BE PLACED IN CONTACT WITH AN APPROPRIATE CELL POPULATION
TO QUANTITATIVELY DETERMINE TOXICITY (CELL MORTALITY) AND MORPHOLOGY (CHANGE IN THE SHAPE OF THE
CELLS).

A PRODUCT IS CYTOTOXIC IF MORTALITY IS > 30% OR MORPHOLOGICAL GRADING IS > 2.

PASSION FOR QUALITY

MKT- 310 REV. 0

For the past thirty years, Alchimia has been
continuously committed to supporting ophthalmic
surgeons with safe and effective solutions able to
improve the daily routine of medical personnel and the
THIS BROCHURE IS PRINTED ON
quality of life of patients. RECYCLED PAPER TO PROTECT THE
ENVIRONMENT AND REDUCE OUR
ECOLOGICAL FOOTPRINT.
SCAN THE QR-CODE AND
Thanks to this approach, we have become one of the FIND OUT MORE ABOUT OUR
PERFLUOROCARBONS.
leading European manufacturers of medical devices for
ophthalmic surgery.

Our liquid perfluorocarbons are cytotoxicity-tested,

PFOA-free and have an H-value that is lower than 10
ppm.

AL.CHI.MI.A. S.R.L.

VIALE AUSTRIA, 14
35020 - PONTE SAN NICOLÒ (PD)
ITALY

+39 049 89.62.074

+39 049 89.62.071

www.alchimiasrl.com
info@alchimiasrl.com