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Shyalt Ultrapure

Altergon Injectable
Sodium Hyaluronate

State of the art
manufacturing facilities

CEP 2014-263 – Rev 01

Altergon Injectable Ultrapure
Sodium Hyaluronate

Brand New European
production plant

CEP 2014-263 – Rev 01

Purity

  • Highly purified Hyaluronate in 2 different specifications (Ultrapure, Plus PH) for Pharmaceutical application in a dedicated Plant 1 (GMP certified)
  • Pharmaceutical and Medical Device qualified users can find the desired quality and safety consistency
  • The "ULTRAPURE" and "PLUS" downstream process ensures to our customers a very low levels of Proteins, Nucleic Acid, Chlorides, Heavy Metals, Iron, Impurities, Ethanol and Water
  • Only one solvent used for all purification steps: ethanol 96%

Plant

Altergon Injectable Hyaluronate
Ultrapure Plus PH

Certification

  • CEP 2014-263 – Rev 01
  • GMP Certification By AIFA
  • MAF filed to FDA

Certification

  • CEP 2014-263 – Rev 01
  • GMP Certification By AIFA
Endotoxins
≤5 EU/GRAM) ≤0.005 I.U/mg 		Endotoxins
≤500 EU/GRAM) ≤0.5 I.U/mg
Molecular Weight range:
40-3,000 kDa 		Molecular Weight range:
40-3,000 kDa
Intrinsic Viscosity:
0.2-3.2 m3/Kg 		Intrinsic Viscosity:
0.2-3.2 m3/Kg

Intended use:

  • Intra-articular administration
  • Intra-ocular administration
  • For Cross-link
  • For Viscosupplements and Viscoelastics

Intended use:

  • Parenteral administration
  • Eye drops
  • Intravesical application
  • Aerosol

Safety

  • Biofermentative origin, produced using a natural, non-GMO bacterial cell strain (wild type): Streptococcus equi ssp. Zooepidemicus (no betahemolytic phenotype). Our strain is deposited with the CNCM at Institute Pasteur Paris
  • Not detectable levels of Nickel, Chrome, Cadmium
  • Our plant/process has CMR, Phtalates, Latex, Bisphenol A, BSE and TSE free certifications
  • The plant 1 is entirely dedicated to the Hyaluronate Production for Pharmaceutical grade
  • The new plant 2 is fully dedicated to Hyaluronate for Medical Device             

Regulatory & Certification

  • The updated version of the MAF for Sodium Hyaluronate has been submitted to FDA on 8th March 2021 with submission number MAF2718/A003.
  • Certificate of Suitability CEP 2014-263 – Rev 01 to the European Pharmacopoeia, Sodium Hyaluronate Monograph granted by the EDQM.
  • Sodium Hyaluronate conforms to the EP, USP, RUSSIA, JP specifications.
  • Validated process in compliance with ICH Q7 and cGMP Eudralex vol.4 part II.
  • Approved by AIFA, Italian Agency for Medicines, which have a Mutual Recognition Agreement on Inspections with the European Union Agencies.
  • Approved by Korean Authority (KFDA) of the Hyaluronate KDMF
  • Our Facilities and related process and systems comply with:
    • - UNI EN ISO 13485:2016 (Medical devices-Quality Management Systems)
    - UNI EN ISO 9001:2015 (Quality management system)
    - UNI EN ISO 14001:2015 (Environmental management system)
    - UNI EN ISO 45001:2018 (Occupational health and safety management systems)

Your Technical Advantages

  • Very fine powder which speeds up production by reducing the dissolution time; granulometry studies reveal a particle diameter smaller than 100 μm.
  • Low intra-batch polydispersity
  • Molecular Weight within the range: 40 kDa - 3,500 kDa
  • High resistance to the thermal treatment / steps of production
  • Customization on demand:
    - Molecular / Weight - Intrinsec viscosity (0.2 - 3.2 m3/kg)
    - Packaging dimensions: time saving and improved productivity by supplying customized weight packaging
    - Sterilized packaging
    - Other parameters for example: Aluminium, Calcium, Magnesium, etc

Technical Data Sheets and product specifications

The following examples reports part of the specifications of Ultra Pure Hyaluronate

We have other products which comply with many important Pharmacopoeias. For further details please contact us

Characteristic European Pharmacopoeia Requirements Altergon Ultrapure Hyaluronate
Nucleic acids Absorbance 260 nm (0.33 % solution, dried) ≤ 0.5 ≤ 0.02
Proteins ≤ 0.1 % ≤ 0.03 %
Iron ≤ 80 ppm ≤ 10 ppm
Loss on drying ≤ 20.0 % ≤ 15.0 %
Microbial contamination
TAMC (Total Aerobic Microbial Count)
TYMC (Total Yeast and Mould Count)		 ≤ 100 CFU/g 
Not reported		 ≤ 10 CFU/g 
≤ 10 CFU/g
Bacterial endotoxins (Gel Clot) < 0.05 I.U./mg < 0.005 I.U./mg
Residual of Ethanol (other residual solvents are excluded by the manufacturing process) < 0.5% < 0.1%
Intrinsic viscosity at 25 C° Not reported 0.2- 3.2 m3/Kg

Plant 2

A dedicated Plant, specifically designed to optimize batch size, quality and purity intended to be used in M.D. production, GMP managed under ISO 9001 system.

ALTERGON MEDICAL GRADE HYALURONATE
Plus MD

Certification

  • ISO 9001 : 2015
Endotoxins
≤500 EU/GRAM) ≤0.5 I.U/mg
Molecular Weight range:
200-2,000 kDa
Intrinsic Viscosity:
0.5-2.5 m3/Kg

Intended use:

Medical Device
(Customer Specifications)