PYROVAC® Sample Vials

PYROVAC® Sample Vials have been specially developed for the automated preparation of radiopharmaceuticals in corresponding devices from various companies. They can also serve as containers for drugs or diagnostics.

The vials are clear glass bottles made of tubular glass according to DIN EN ISO8362-1 (10ml, 20ml and 25ml) or of molded glass according to DIN EN ISO8362-4 (30ml, 50ml and 100ml), of hydrolytic class I (borosilicate glass), with attached rubber stopper Type I, (multiple piercing possible), closed with a flip-top crimp cap provided with a plastic cap made of PP. This is removed before use of the vial so that the piercing point of the septum reveals with a diameter of approx. 8 mm.

PYROVAC® Sample Vials are provided with a vacuum (approx. 10 mbar). To ensure proper sterilization, each bottle contains between 100 and 1,000 μL of water for injections, depending on its size. The vials are sterile inside with S.A.L of 10⁻⁶ and free of detectable endotoxin (endotoxin level < 0.001 I.U. / mL nominal volume). They are free of visible particles. Sub-visible particle contamination is less than 10% of the limits specified in the European Pharmacopoeia (Ph. Eur.) and the US Pharmacopoeia (USP).

PYROVAC® Sample Vials

PYROVAC® sample vials are vacuumized, sterile and free of Endotoxins. They are recommended for preparation and storage of radiopharmaceuticals. They can serve as containers for drugs and diagnostics as well.

Safety Data Sheet Specification Certificate of Conformity

Specifications

  • Sterility: S.A.L. of 10⁻⁶
  • Endotoxin: < 0.001 I.U. per ml volume
  • Particles:
    •  Visible: None
    •  Invisible: ≤ 10% of limit values indicated in Ph. Eur. and USP specifications
  • Vials:
    • DIN EN ISO 8362-1 (PYROVAC 10, 20, 25)
    • DIN EN ISO 8362-4 (PYROVAC 30, 50, 100)
  • Glass: Hydrolytic Class I (borosilicate glass)
  • Septum /  Stopper: Brombutyl (in accordance with Ph. Eur., USP and DIN EN ISO 8362)
  • Vacuum: approx. 10 mbar
  • Water content: 100 – 1,000 µL aqua ad iniectabilia (water for injection, WFI)
 

Product Size Vials / Pack Article No. Quantity
PYROVAC® 10 10 ml 80 1960500
PYROVAC® 15S 15 ml 10 1960497
PYROVAC® 20 20 ml 10 1960495
PYROVAC® 25 25 ml 10 1960490
PYROVAC® 30 30ml 10 1960489
PYROVAC® 50 50 ml 10 1960492
PYROVAC® 100 100 ml 10 1960491