Following each step of production, 10% or more micropipets are examined by our QC 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 micropipet

• Quality Assurance

• Quality Testing

• Humagen Guarantee

• The Facility

• Glass Preparation

• Specifications

• Sterilization

• Customization

• Quality Documents

Each master lot of micropipet glass and Pasteur pipets is tested for toxicity in a one-cell mouse embryo assay (MEA). The percentage of embryos exposed to the micropipets or Pasteur pipets that develop to the blastocyst stage are compared to control embryos. The embryos are assessed at 96 hours of culture. The product and control is assessed and the product will be considered non-toxic if the percentage of blastocysts exposed to the product is greater than or within 10% of the control percentage. 70% or more of the control embryos must reach the blastocyst stage for the test to be considered valid. Additionally, each master lot of micropipet glass and Pasteur pipets is endotoxin tested using the Limulus Amebocyte Lysate assay. Each lot must be less than 20 endotoxin units per device to pass. Specific testing information and results can be found on the Certificate of Analysis provided with each lot of micropipets and Pasteur Pipets. During product design, product or production changes, additional packaging, sterilization and expiration date testing will also be conducted as necessary.

In addition, independent laboratory tests of packaging, sterilization and expiration date validation are conducted on all products during design and upon changes to materials or production. Certificates of Analysis are sent with each lot of micropipets and Pasteur Pipets.

The Humagen Guarantee

The Facility

Humagen is ISO 13485 certified, meeting quality system requirements of the Canadian Medical Device Regulation and the European Union Medical Device Directive. Humagen products in this catalog, for IVF use, are FDA cleared.

Glass Preparation

Micropipet Specifications

The standard overall length of most micropipets is 5.4-5.8 cm. Biopsy, Stem Cell and Piezo Drill micropipets are 5.5-6.5cm. Customized micropipets may be ordered in lengths up to 9.0cm.

Micropipets 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. Used by our customers for over 10 years, this packaging has been extensively tested for toxicity and integrity. Humagen packages 10 micropipets in a clear plastic box with a cushion. The box is labeled and shrink-wrapped and includes a radiation indicator on the bottom of the box. A red indicator provides assurance that the product has been gamma radiated. Following final packaging, the micropipets are stored at room temperature (20-25°C). A colored dot may be found on beveled micropipets. This dot is used during production for orientation of the micropipet's beveled opening. Some users may find this dot useful for orienting the micropipet in their micromanipulation system.

Sterilization

Customization

We offer customization of our standard products so you may slightly modify any existing micropipet design, e.g. you may want a long spike on an ICSI micropipet, or a different overall length of micropipet. To customize a product, complete the form on page 17 and fax it to us or to your distributor. We will be pleased to make micropipets to your specifications. You may order your micropipets without tip protectors, or bent 1.0μm from the tip, at no extra charge.

You may also completely design a new micropipet by clicking here and completing our Custom/Customized Product form and then faxing to us or to your distributor. We will notify you if we can make your product and what the price will be. Custom micropipets must be used for research only and are not intended for the IVF market.

Quality Documents

For your convenience, you may download a PDF of our quality certificates by clicking on the links below.

CE Certificate

ISO 13485