How To Begin Testing and Certifying Your Products Endotoxin Free

To begin certifying your product Endotoxin-Free, a sample of the product must be received by our Services Division to evaluate how best to test your particular product. Preliminary testing will be required for any raw material or liquid product. Preliminary testing will provide the concentration at which your product can be routinely tested.

An extraction procedure must be determined for most devices. Once an extraction procedure for a device is approved, it is used each time that product is received for testing. Many products will fit one of our pre-designed extraction procedures, such as microcentrifuge tubes, PCR tubes and pipet tips. However, because all products are not the same, each product received is evaluated on an individual basis. Liquid solutions, reagents and solids, due to the diversity of these products, require a separate test procedure to be designed each time a product of this type is submitted.

You and your company decide upon a testing schedule that best fits the needs of your particular product. ARYTE Bioscience can work with you to design a testing schedule that accomplishes this goal.

Sampling Guidelines for Endotoxin Testing

 

Medical devices

The test is described in current USP guidelines. These guidelines state that the Center For Devices and Radiological Health (CDRH) recommends testing 2 devices for lot sizes under 30, 3 for lot sizes 30-100, and 3 percent of lots above 100 in number, up to a maximum of 10 devices per lot. (3).

 

Human and animal drugs and biological products

I.          Inhibition and enhancement testing

At least three production batches of each finished product should be tested for inhibition and enhancement.

II.         In instances where the drug is manufactured in various concentrations of active ingredients while the other components of the formula remain constant, only the highest and lowest concentration need be tested.

III.        The sampling technique selected and the number of units to be tested should be based on the manufacturing procedures and the batch size. A minimum of three units, representing the beginning, middle, and end, should be tested from a lot. These units can be run individually or pooled. If pooled and any endotoxin is detected, repeat testing can be performed according to USP guidelines.

 

Lot Release Testing

A lot is defined by the manufacturer as a traceable batch of product which can be tested, isolated, and tracked should a problem arise. ARYTE Bioscience scientists are qualified to operate tests according to USP Guidelines for Endotoxin testing. USP Guidelines for medical device endotoxin testing require a maximum of 10 units per lot. For pharmaceuticals, a minimum of product must be determined. Please call to discuss testing requirements. 

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