What kind of standard pipette tips is Endotoxin-free level ?

Pyrogen-free consumables are consumables without exogenous endotoxin, including pyrogen-free pipette tips (tip boxes), pyrogen-free test tubes or called endotoxin free tubes, pyrogen-free glass ampoules, endotoxin-free 96-well microplates, and endotoxin-free water (depyrogenated water use in the bacterial endotoxin test ), and etc. Among them, the water for bacterial endotoxintest by gel clot method in the Pharmacopoeia 05 edition refers to sterile water for injection with endotoxin content less than 0.015EU/ml. Now the latest version of Pharmacopoeia, the BET water is less than 0.005EU/ml.

Pyrogen: Also called pyrogen or exothermic factor. substances that can cause an increase in body temperature.
Heat Source: An object that emits heat. Such as burning matches, charcoal, etc.
The above two are two completely different concepts.

The so-called “non-pyrogenic consumables” and “pyrogenic response” of some manufacturers and merchants are actually very unprofessional and misleading names. The correct ones should be “Pyrogen-free” and “Pyrogen Response”.

Laboratory Environmental Conditions for Endotoxin free experiment:

The BET can be performed in most modern laboratories under controlled conditions.

Appropriate aseptic technique is important when preparing and diluting standards and handling samples. Gowning practice outside of normal laboratory personal protective equipment (PPE) requirements is not a concern unless the product under test demands specific analyst safety considerations due to toxicity or infectiousness. Gloves should be TALC-free, as the TALC may contain significant levels of endotoxins. Plate readers, water baths, and dry heat blocks (dry heat incubator) used for sample incubation should be on a laboratory bench away from heating, ventilation, and air conditioning (HVAC) ducts, significant vibration, and laboratory traffic that could affect the test results. Sample hold times and conditions should be determined and subsequently documented, if necessary, to ensure that accurate test results can be generated in the qualified time.

For example, if the laboratory receives a Water for Injection (WFI) or in-process sample, must it be refrigerated or can it remain at room temperature, and for how long? Prior to testing, it is recommended that the primary sample container(s) be adequately mixed before removing the test aliquot(s) for either direct testing or subsequent dilution.

Tianjin Ruikang Supplied those pipette tips which is passing the inspection of endotoxin-free level.

Depyrogenation of pipette tips is important for several reasons : (endotoxin-free pipette tips, or called pyrogen-free pipette tips)

1. Prevention of contamination: 

Endotoxins are ubiquitous in the environment, and they can easily contaminate laboratory equipment and materials, including pipette tips. 

Even a small amount of endotoxin contamination in the pipette tips can lead to inaccurate results in endotoxin test assays. 

Depyrogenation removes or inactivates endotoxins from the pipette tips, thus preventing contamination.

2. Ensuring accuracy of results: 

Endotoxin test assays, such as the Limulus Amebocyte Lysate (LAL) assay, are highly sensitive and can detect very low levels of endotoxins. 

Even small amounts of endotoxin contamination in the pipette tips can affect the accuracy of the test results. 

By using depyrogenated pipette tips, the accuracy of the endotoxin test assay is ensured.

3. Regulatory compliance: 

Depyrogenation is a critical step in ensuring compliance with regulatory requirements, such as those set forth by the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). These regulations require that all equipment and materials used in endotoxin test assays be free of endotoxins, and that depyrogenation be used to achieve this.

4. Cost-effectiveness: 

Inaccurate results in endotoxin test assays can be costly in terms of time, resources, and potential patient harm. By using depyrogenated pipette tips, the risk of inaccurate results is minimized, and the overall cost of the endotoxin test assay is reduced.

In summary, depyrogenation of pipette tips (endotoxin-free pipette tips, or called pyrogen-free pipette tips) is an essential step in ensuring the accuracy and reliability of endotoxin test assays, and is necessary to comply with regulatory requirements and prevent contamination.