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