ISO 8 cleanroom certification for Biohit tip production

01/18/2011 08:12

Biohit's tip production received ISO 14644 class 8 cleanroom certification during 2010 as one of few tip manufacturers.

Tip purity and safety in your laboratory work have always had a top priority in Biohit's tip production. We have followed strict purity procedures in the tip production for years and have now got an official recognition for our work, the ISO 8 cleanroom classification.

The purity and high automation in the production facility are especially essential to avoid DNase, RNase or endotoxin contaminations. These substances are usually of human or bacterial origin and most of them can not be removed using common sterilization methods like autoclaving or irradiation, which is a rarely known fact - thus it is essential to avoid the contamination in the first place.

Biohit has taken the following measures to ensure the purity of the tip production for years and will continue to do so:

• Using pure virgin polypropylene as raw material for tips (not recycled plastics)
• Tip production process is highly automated, human contact is minimized
• Personnel is wearing special clothing, eg. gloves, masks and hair nets
• Tip trays and Refill Packs are wrapped in air-tight plastic
• An independent laboratory tests each certified tip lot (Single Trays and Refill Packs) for DNase, RNase and endotoxins
• In addition a selection of tip products are e-beam pre-sterilized

We also perform regular purity checks required by ISO 14644 to conform to the ISO 8 classification.

ISO 14644 Cleanroom Certificate can be found here