Purity Levels

Purity Levels

To achieve reliable results in diagnostics, science, and research, the consumables used must meet special requirements in raw material quality and certified purity standards.

With high-quality materials, modern manufacturing facilities, and careful controls at all stages of production, SARSTEDT meets these requirements. Inspired by the requirements and needs of our customers, we offer you premium-quality equipment – precise, innovative, and independently tested according to applicable limits. Learn how to select consumables with optimal purity for your applications and what distinguishes SARSTEDT's strictly certified purity levels.

Why Purity is Essential in Laboratories ?

Sensitive analyses, expensive reagents, and sensitive biological specimens require maximum purity for the consumables used or require the use of consumables with maximum purity. To ensure reproducible and reliable results, using high quality consumables is essential.

After all, the challenges of everyday laboratory work must be met with thoughtful solutions. On one hand, contamination by microbial residues can taint samples or affect cell or bacterial growth and on the other hand accidental introduction of contaminants or interfering substances through use of insufficiently tested consumables can generate false-positive or false-negative results – with far-reaching consequences.

Due to the trend towards using smaller sample volumes, minimising potential interactions between the analytes and the sample containers is becoming increasingly important. The use of PCR consumables – for example, in sample preparation and storage as well as sample transport – often requires maximum sample recovery. For this purpose, we at SARSTEDT have designed technically advanced PCR products with DNA Low Binding and Protein Low Binding properties.

Our Purity Levels for Precise Results

For particularly demanding applications, SARSTEDT offers consumables in certified purity levels. Below is an overview of the purity levels with examples of possible applications and the purity criteria met:

SARSTEDT Quality

Quality management (QM) is a systematic process within an organisation aimed at ensuring and continuously improving the quality of products or services they provide. It involves planning, monitoring, controlling, and evaluating all aspects of production and service processes with the goal of maximising customer and stakeholder satisfaction.

Effective quality management is based on a set of principles such as customer orientation, leadership quality, involvement of people, process orientation, and continuous improvement. These principles help organisations optimise their performance and meet regulatory requirements as well as internal standards.

The implementation of quality management often follows specific frameworks and standards, such as ISO 9001, which sets internationally recognised standards for an organisation's quality management system. Tools and techniques like Total Quality Management (TQM), Six Sigma, and Lean Management are also employed to improve the efficiency and effectiveness of processes.

In summary, quality management ensures that an organisation consistently delivers products and services that meet or exceed customer requirements and enhances the efficiency of internal processes.

The quality standards that form the basis of SARSTEDT’s manufacturing processes can be read here:

PCR Performance Tested

Our PCR Performance Tested consumables, such as pipette tips and PCR plates, are ideal for nucleic acid analysis in molecular biology and crucial pre-analytical steps like sample preparation, storage, and transport. These products, tested by an independent laboratory, are free from human and bacterial DNA, DNases and RNases, as well as PCR inhibitors.

To exclude any significant inhibitory effects on the PCR reaction and to ensure reproducible results, we recommend our carefully tested consumables.

Products certified with the PCR Performance Tested purity certificate meet the following limits:

• Human DNA <0.5 pg/µl

• Bacterial DNA <0.02 pg/µl

• DNase <1x 10−5 U/µl

• RNase <1x 10−9 Kunitz units/µl

• PCR inhibitors <0.5 cycle Ct value shift

Biosphere® plus

Our Biosphere® plus certified products are the optimal choice for highly sensitive analytical processes. Through a special decontamination process, all the SARSTEDT products which are awarded with this quality seal are guaranteed to be free from DNA or other biomolecules. The items are also sterilised with Ethylene oxide (EtO). In addition to production under laminar flow and tests conducted by independent laboratories for the biomolecules listed below, certification of compliance within limits for pyrogen and ATP-free conditions offers an additional level of safety.

• Human DNA <0.5 fg/µl

• Bacterial DNA <0.2 fg/µl

• Sterility validated according to ISO 11135

• ATP <1x10−12 mmol/µl

• Pyrogens/endotoxins <0.002 EU/ml

• DNase <5x 10−7 U/µl

• RNase <5x 10−11 Kunitz units/µl

• PCR inhibitors <0.5 cycle Ct value shift

TC Tested

SARSTEDT products with TC Tested certification form the basis for establishing vital cell cultures. Flasks, dishes, and plates for classical cell culture provide growth surfaces for various cell types and cell lines, making them essential for vital cell growth. The practical colour code also allows for quick and easy identification of the appropriate growth surface in a busy laboratory environment. We firmly believe that products in contact with cells should not have any disruptive effects on them. Therefore, the production of our TC Tested certified products, ensuring optimal cell culture safety, adhere to strict purity conditions.

• This includes compliance with the following limits:

• Sterility validated according to ISO 11135

• Pyrogens/endotoxins <0.06 EU/ml

• Non-cytotoxic according to ISO 10993

• Human DNA <0.5 pg/µl

• Bacterial DNA <0.02 pg/µl

• DNase <7.1x10−5 U/µl

• RNase <7.1x10−9 U/µl

Cryo Performance Tested

For the storage of cells or tissues at ultra-low temperatures down to -196 °C, our Cryo Performance Tested tubes are ideal. Even after long-term cryopreservation, you achieve reproducible results and vital cell growth.

SARSTEDT's CryoPure tubes are certified according to the following limits:

• Sterility validated according to ISO 11137

• Pyrogens/endotoxins <0.06 EU/ml

• Non-cytotoxic according to ISO 10993

• Non-mutagenic according to Ames Test II

• Human DNA <0.5 pg/µl

• Bacterial DNA <0.02 pg/µl

• DNase <1x10-5 U/µl

• RNase <1x10-9 Kunitz units/µl

Forensics

In human identification analysis – for example, in forensic criminology – the highest purity conditions are required. SARSTEDT's DNA-free forensic swabs can be used by specially qualified personnel for the collection of reference samples and securing of DNA traces at crime scenes.

The EtO fumigation process specially developed by SARSTEDT for forensic practice ensures optimal product purity in accordance with ISO standard 18385. The identification code for clear assignment prevents the mix-up of samples from different individuals.

Material Properties

Many applications in research, laboratory, and analysis require consumables with special properties. While good heat resistance for the plastics used is crucial for autoclaving samples, vessels for cell culture should have the highest possible transparency for easy assessment of cell growth.

With this table of material properties, you can easily determine which materials suit your application purpose.

Batch Certificates

Compliance with specific quality requirements for quality assurance within the production process and purity are documented through our batch certificates.

Here, you can search for and download the corresponding batch certificate by entering the batch-specific data. Please note that a certificate may not be available for all of the products.