Endotoxin-Free Certification

Endotoxin-Free Certification
This certification follows USP chapter <85> and ANSI/AAMI ST72:2011 guidelines and FDA regulations to certify any of a variety of products to be free of contaminating endotoxins or to quantify endotoxin levels.
Size/Component Catalog #
Download submission form
Service Description


  • Experienced - MO BIO has over 22 years of experience in providing endotoxin detection services and products for endotoxin removal to many major medical device companies and suppliers of plastic consumables
  • Qualified - All MO BIO Services technicians have been qualified according to the ANSI/AAMI ST72 regulations to utilize the LAL Gel Clot method to test raw materials or end products for the presence of endotoxins

Endotoxins are found in the lipopolysaccharide complex of the outer membrane of Gram negative bacteria. When the cell dies, the membrane of the cell ruptures and endotoxins are released into the surrounding environment. Endotoxins are a pyrogen, which is defined as a substance that can cause a fever response. Endotoxins can be found in the air, water and soil, on human skin, and in any non-sterile environment.

This is of great concern in the medical device and pharmaceutical industries as well as the biotech and research fields, because endotoxins can interfere with many common laboratory techniques such as the creation and maintenance of cell culture lines. Additionally, when endotoxin contamination affects therapeutic reagents, it can incite a dangerous inflammatory response in human patients. 

Certifying products endotoxin free has become a common practice among general laboratory plastics manufacturers as well as medical device and pharmaceutical companies. The presence of endotoxins is an indication of the overall purity and microbial activity of a particular product or raw material. Testing your product lines for this common contaminant will add integrity to your products and will enable a wider range of customers to utilize your products for their experiments and applications.



Test Methods

MO BIO Laboratories, Inc. and all its Services technicians have been qualified according to FDA regulations to utilize the LAL (Limulus Amebocyte Lysate) Gel Clot method to test raw materials or end products for the presence of endotoxins. This qualitative method uses components found in the blood of the Blue Horseshoe Crab, Limulus polyphemus, which forms a gel-like clot when incubated in the presence of endotoxins. This method is used to determine if products or materials are "endotoxin free". The sensitivity or detection limit of the endotoxin test is 0.06 EU/ml (Endotoxin Units). Products and materials can be certified by MO BIO to a sensitivity of 0.03 EU/ml upon request (requires an additional $33 handling fee and 3 additional business days for processing).

Upon receiving the product to be tested at MO BIO, a product extract is made and then exposed to and incubated with the horseshoe crab lysate (LAL). The product extract is incubated along with a standard series of the Control Standard Endotoxin (CSE) as the positive control and the unexposed extract fluid as a negative control. After the incubation period, the tubes containing the controls and the extract are observed for the presence of the gel clot. A clot indicates the presence of endotoxins. No clot indicates absence of endotoxins (i.e. < 0.06 EU/ml).

Once the certification assay is completed, the customer is contacted with the preliminary results and a report containing a data and results sheet and a certificate of analysis is emailed to the customer.

Contact Services

Contact Services

Our Services team has over 23 years of experience in providing services that keep your products competitive and in demand. Our customers include many of the top plastics and medical device suppliers in the industry. Our services specialists can also work with you to develop a custom testing schedule and/or custom tests that fit the specific needs of your products. We are located in Carlsbad, CA, USA.