Recently ProCleanroom supplied, installed and validated a mobile modular cleanroom according to ISO14644, class 7 to new medical devices venture U-Needle; a high tech company who developed and now produces special silcon micro needles for medical applications. Decision criteria were flexible design, short leadtime and competative pricing. In case the company decides to relocate, the cleanroom will easily move with the company, securing their current investment.
Silicon micro needle
U-Needle in Enschede, The Netherlands, develops and manufactures silicon micro needles using a unique silicon etching process. The micro needles are intended for any application asking for an accurate, rapid and pain free subcutaneous and intradermal delivery, such as drug delivery, vaccinations and in-skin aesthetic treatments.
Atom sharp and user friendly
The U-Needle silicon micro needles are atom sharp utilizing an ultra short bevel. The micro needles are capable of perpendicular injection in the dermal layer, combining both high accuracy and unmatched ease of use. Increase in manufacturing capacity whilst achieving and maintaining the desired quality levels were the main reasons for the cleanroom installation. The manufacturing and inspection of the silicon micro needles will now take place inside their own new cleanroom facility.