Confidence in the products you use to support your science

The laboratory supplies you use play an important but often underestimated role in the success of your science.  Our commitment to supporting your scientific achievements begins with ensuring that you can rely on Thermo Scientific products to be of the highest available quality and to meet or exceed your expectations for performance according to the requirements of your applications. Our Fit for Purpose designations provide customers with an easy way to find and select the lab consumables that are ideally suited to your specific application needs. And when you're ready to buy our products, you can rest assured that our global footprint and regional manufacturing strategy provides supply chain security, while our commitment to sustainability helps ensure  products are ready when you need them, today and tomorrow. Now you can confidently forge ahead, achieve reliable results and focus on your science.  

Look for Fit for Purpose designations to find products ideal for your needs

To identify products that meet your needs and requirements of your scientific work, simply look for the appropriate Fit for Purpose designation and be confident the products have been rigorously tested with quality documentation readily available. (e.g., Certified quality, Sterile, PCR ready, Sterile & PCR ready). For every product that is qualified under this program, a lot-specific certificate of quality is available for review with detailed information on the materials, manufacturing standards and testing associated with it. 

Certified quality

Our commitment to quality manufacturing practices forms the foundation of helping our customers achieve reliable results, regardless of the products they use. 

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Sterile

Be confident of the elimination of microorganisms in your consumables. Find out what you need to know about this important designation.
 

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PCR ready

Polymerase Chain Reaction processes are exceedingly sensitive and require consumables that meet high standards of purity.
 

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Sterile & PCR ready

Certain applications benefit from heightened purity standards that can produce more reliable results.  Find out if this dual certification is right for you.
 

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Product testing

Our plastics and consumables are designed and manufactured with the rigors of the scientific lab in mind. We understand that the precise nature of your science demands an equal level of precision from the products you use because variables can compromise or destroy your work. For this reason, Thermo Scientific lab products are subject to comprehensive and rigorous testing, from the raw materials, to manufacturing processes and final product preparation to provide our customers with products that can help them achieve scientific success and reliability of results.  Our Fit for Purpose designated products incorporate a variety of testing and quality control procedures in accordance with global standards certified through the International Standards Organization (ISO) and United States Pharmocopiea (USP), among others. 

Testing methods and focus areas

The following is presented as generalized, summary information.  Detailed testing parameters, methods and certifications can be found for individual product types and manufacturing lots in the associated lot-specific certificate of quality, available for each certified product.

Raw materials

Our labware and containers are made from only top-quality laboratory, pharmaceutical, and food grade plastic resins. Our resins are selected to minimize additives and reduce potential leachables, and without plasticizers, fillers or animal derived products.

Manufacturing

Strict adherence to ISO 9001 and 13485 manufacturing standards with extensive controls and inspections for product functionality, precision shape, low wetting, chemical and thermal resistance, and stability, and other criteria.

Sterility

The presence of microorganisms on labware can negatively affect many kinds of research analysis and culture growth. We test for the elimination of living organisms to a specified Sterility Assurance Level (SAL) in accordance with ISO 11137.

Endotoxins (Pyrogens)

Residual thermostable substances (pyrogens) from the outer layer of microorganisms can negatively affect cell function and cause inaccurate results in cell culture, medical and pharmacological research. We test for endotoxin contamination using the Limulus Amebocyte Lycate (LAL) gel clot assay according to current FDA regulations for products designated as endotoxin free.

DNase/RNase

Deoxyribonuclease (DNase) and Ribonuclease (RNase) are enzymes that can degrade DNA and RNA respectively.  Removal of DNase and RNase contamination is critical for accurate DNA analysis. We test for the elimination of these enzymes using the nuclease assay method for products designated DNase and RNase free.

Human DNA

 

Elimination of human DNA from lab consumables is critical for accurate DNA research and analysis.  Our products designated as Human DNA free are tested for contamination using Polymerase Chain Reaction (PCR). Test reactions, including the appropriate positive and negative controls are prepared with primers specific for human and mouse DNA targets. The absence of amplicons in the test reactions indicates that the product is free from detectable DNA contamination.

To help ensure products are human DNA free, Thermo Fisher Scientific utilizes in its manufacturing processes controlled environments, access restrictions, and gowning to prevent products from DNA contamination

PCR inhibitors

 

The amplification of nucleic acids in a sample is the basis for sensitive Polymerase Chain Reaction (PCR) analysis. Due to the sensitivity of the PCR method, it is critical that lab consumables used are free from substances that can inhibit the process and negatively affect results. Products designated as PCR inhibitor free are tested for the elimination of these substances by amplification of a human DNA target sequence using PCR and analyzed by gel electrophoresis. Test and control reactions must amplify the expected DNA fragment with equivalent yield and purity to verify that the product is free of detectable PCR inhibitors.

Adenosine triphosphate (ATP)

The presence of ATP indicates biological contamination. Products are tested for the presence of ATP using a luciferase-based detection assay to be designated as ATP Free.


Limits of Detection (LOD)

Limits of detection presented in this table are summarized for all products and presented as a minimum standard. Individual products may be subject to lower limits of detection and specific testing methods which can be found on their lot-specific certificate of quality.

Test parameter

Human DNA

RNase

DNase

PCR inhibitors

Sterility

Endotoxins

Test method

PCR

Nuclease Assay

Nuclease Assay

PCR

E-beam or gamma irradiation or EtO gassing

Limulus Amebocyte Lysate (LAL) gel clot or Kinetic turbidometric

LOD

< 30pg

< 1.0 x 10-9 Kunitz Units/µl

< 8.0 x 10-7 Kunitz Units/µl

control yield = test yield

Tested in accordance with ISO 11137

SAL varies by product

Tested in accordance with USP 85 sensitivity varies by product


Certificate of product line quality

All products sold under our Fit for Purpose designation program come with a certificate of product line quality which details its quality attributes, testing criteria and methods used to achieve the designation. Additionally, lot-specific certificates of quality are available for individual products and can be downloaded when purchasing products through our ecommerce platform. 

Style Sheet for Global Design System