Manufacturing Facility

INGfertilityTM operates according to Good Manufacturing Practices (GMP). Pre~Seed® is made under contract for INGfertilityTM at neighboring UnicepTM Packaging in Idaho. UnicepTM has the highest international quality certification of ISO 9001 2000.


Lot Release Testing

Each and every lot of both Pre~Seed® & Pre’TM are tested to ensure no deleterious effect on human sperm. This is a unique feature of our products. The following tests are performed prior to the release of either Pre~Seed® or Pre’TM:

Physical Properties

The product physical properties must be within the following specifications:

visual: clear/opaque
pH: matched to fertile cervical mucus 7.1-7.45
osmolality: mOsm/kg 260-365
viscosity: cps 7,000-12,000

Human Sperm Motility

Sperm motility after 30-minute exposure to 10% Pre~Seed® or Pre’TM solution is equal to 80% or more of the motility seen for sperm with no product present. This allows for accommodation of some slowing of sperm velocity due to increased viscosity with the lubricant products.  This test is done by an independent laboratory (NW Andrology & Cryobank).

Mouse Embryo Assay

No harm to developing Mouse Embryos. This test assures that one cell mouse embryos develop to the blastocyst stage when cultured with Pre~Seed® at greater than 85% (equivalent to control medium). This analysis is the Special Control for all media used in assisted reproduction such IUI or IVF. It is performed by the independent Embryotech Laboratories.

Stability Testing

Stability testing of Pre~Seed® and Pre’TM was performed in accordance with the International Conference on Harmonization (ICH) guidelines for “Q1A Stability Testing of New Drug Substances and Products”. Based on data collected, the projected shelf-life from the date of manufacture of the products is 2 years.

Condom Compatability

Compatibility of our Pre’TM Lubricant with polyurethane (Male Factor Pak®) and latex condoms was performed by Nelson Laboratories (Salt Lake City, UT) in accordance with the regulations (21 CFR part 58) for compatibility testing of lubricants with condoms. Results from this testing demonstrated that Pre’TM is condom compatible and has no significant effect on condom integrity.