Quality Assurance

ORIGIO strives to go the extra mile. To ensure top quality for our products and services, we implement the following:

ORIGIO MediCult Media:

  • SSR® (Synthetic Serum Replacement: in the USA, ART Supplement) is used to partly replace HSA.
  • Raw materials are of pharmaceutical grade for protein sources (e.g. human serum albumin) and other active ingredients.
  • Water meets the requirements set for Purified Water in the current Ph.Eur.
  • Shelf life is stability tested in conditions similar to use.
  • Products are packed in tamperproof boxes with a comprehensive package insert enclosed.
  • Shipment of the products is in insulated boxes with cooling elements ensuring optimal temperature conditions.

ORIGIO Humagen Pipets:

We stand behind our pipets 100%, here is why:

  • Following each step of production, a random sampling of micropipets is examined by our Quality Control staff for potential defects. This process is repeated until the pipets reach the end of production. For example, an ICSI micropipet is examined at four stages of production before it becomes a finished product, where it is once again checked. This assures the end user a consistent and well-tooled micropipette.
  • All micropipets are meticulously prepared using borosilicate glass tubing. Most micropipet glass has a 1mm O.D., except for denuding pipet glass which is 1.5mm O.D. Each lot of glass is extensively cleaned and baked, then MEA and LAL tested.
  • Sterilization: all micropipets for IVF use are sold sterile. Sterilization is done at an approved gamma radiation facility following ISO 11137 guidelines. The shelf life of sterile micropipets is two years from the date of manufacture. All Pasteur Pipets are sterilized using dry heat to the assurance level of 10-6 SAL. The shelf life is 3 years for Pasteur Pipets packaged in pouches and 2 years for those packaged in a bulk tray.
  • Packaging: we take special care of the packaging of our micropipets. They are seated in santoprene caps (various colors indicate the type of micropipet), and covered with a polystyrene tube that fits into the cap and forms a microbial barrier. Package integrity tests have been conducted to ensure they form a sterile barrier and are non-toxic. Ten micropipets are packaged in a clear plastic box then. The box is labeled and shrink-banded to ensure product has been untampered. A red radiation indicator on the bottom of the box provides assurance that the product has been gamma radiated.