Caps

When it comes to caps, not only can you be assured of complete safety, you can be sure of finding exactly the right cap to suit your needs.

   

Generally:

  • caps minimise the aerosol effect thus minimising the risk of contamination, and, due to the recess in the cap, eliminate any contact with blood droplets.
  • The rubber of the cap is manufactured from materials recommended for the pharmaceutical field.
  • Rubber parts are siliconised to prevent erythrocytes sticking.
  • Cap colours correspond to the recommendations from the International Standards Organisation (ISO 6710 ); just one glance is all that is necessary to determine the tube type. Cap rings are also colour-coded:

tubes giving a paediatric draw have white rings,
serum tubes with beads have a red ring
serum, heparin and EDTA tubes with gel are indicated with a yellow ring.

  • All other tubes have a black ring, the ring serving not only for identification purposes but also as a stabiliser for the rubber stopper.

Screw caps:

  • For 13mm tubes.
  • The cap is removed with a twist-pull action allowing the tube to be de-capped and re-capped several times.
  • This cap is ideal for transportation as the cap cannot loosen accidentally.

Non-screw caps:

  • For 16mm tubes.
  • This is a safety grip cap which is removed with a gentle pull action.
  • Re-capping is possible whenever required.

"Non-ridged" caps:

  • This version is available on request for all 13mm tubes.
  • The cap is removed with a simple pull action.
  • Ideal for sites where many tubes are de-capped without re-capping, e.g. at a blood bank.

 

Quality Management System

All aspects of production and work methods employed throughout the whole of Greiner Bio-One conform to ISO 9001 (EN 29001) and EN 46001. Greiner Bio-One has been certified according to these standards since January 1995, and was recertified in 1998 by BVQI (Bureau Veritas Quality International).
Rigorous inspections and control checks are carried out, the first taking place as soon as the raw materials enter the plant. During actual production, in-process inspections are made, and a final check is made when production is complete and products have been sterilised.

Hygiene

Production is carried out under strictly controlled conditions. (For example: constant control of humidity and temperature, and regular observation of microbiological contamination of air in the production plant).
Very strict hygiene regulations are adhered to. All employees of Greiner Bio-One must be familiar with these regulations, and any visitor to the production, must acknowledge the regulations too. Any person entering the production must wear the appropriate hygienic clothing which is specified and provided by Greiner Bio-One.

European Requirements

Our medical devices, i.e. double-ended needles, HOLDEX® + pre-attached butterfly etc. are certified according to the Council Directive N°. 93/42/EEC concerning medical devices by the notified body TÜV Product Service GmbH Munich (Id. N°. 0123).

  • Regarding in vitro diagnostic products, Greiner Bio-One  meets the requirements of the IVDD (In Vitro Diagnostic Directive), which is a European legal requirement.

For further information on this, see the Medical Device Safety Service homepage.

USA Requirements

  • We already have FDA Approval for most of our medical devices.
  • Tubes and the Multi-Use holders are classified in accordance to 21CFR 862.1675 "Blood specimen collection device".
  • HOLDEX® and multi-sample needles are classified in accordance with 21CFR 862.5570 "hypodermic single lumen needle".

For further information on this, see the FDA advice homepage.








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