Normal Human Serum

Technopath's Normal Human Serum products are manufactured from a high quality source of human plasma and defibrinated using techniques developed by our experienced team.

Many of our customers select this as a base matrix in the manufacture of their own QC, EQA, PT and calibrator products due to low levels of protease activity, closeness to patient sample performance and our ability to supply a consistently high quality product. By choosing our product it saves time for our customers in their facilities and allows them to focus on downstream value-added activites.

Our process starts with high quality plasma with full traceability back to the individual donor units. The plasma is defibrinated by removing the clotting factors. The material is then depth filtered through pore sizes ranging from 8 micron to 0.22 micron and dialysed against multiple buffer solutions to normalise salt levels and increase the total protein concentration of the pool. In-process testing is performed and analyte adjustments are made to ensure the material achieves the desired targets. The product is depth filtered once more, prior to passing through a 0.22 micron absolute filter before final dispensing.

This product is suitable for use in manufacture of In-vitro diagnostic products: controls, calibrators, reagents and standards, as well as EQA specimens and PT samples. Also recommended for Research and Development applications.

Please note, this material is not suitable for use in the manufacture of injectable or transfusable products.

Resources:

BrochureBrochureCatalogue
Two glass beakers containing Normal Human Serum

Product Description

Technopath's Normal Human Serum is manufactured from high quality plasma, with a final Total Protein concentration of 70-90 g/L (or 7.0-9.0 g/dL). The addition of preservatives is optional. The material is filtered to 0.22 micron absolute pore size prior to final dispensing. Our off-the-shelf product contains salt concentrations at normal physiological levels.

Our team also work closely with each of our customers to develop and tailor our Normal Human Serum products to meet the exact needs of our partners.

The re-certification interval for this product is 3 years from the date of manufacture.

The product is shipped on dry-ice and, to ensure optimal performance, should be stored at -20°C or colder upon delivery.

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Features

Product can be manufactured to custom specifications providing you with the solution you need

Manufactured from high quality, consistent source of plasma that is recovered from units of whole blood

Serum is defibrinated using proprietary processing techniques developed by Technopath with or without the use of bovine thrombin

Preservatives addition is optional and based on customers' individual preferences

Off-the-shelf product contains normal salt levels

Filtered to 0.22 micron absolute pore size to reduce levels of potential bio-burden

“Tailored” specifications can be developed in conjunction with the customer to provide a customised solution to match specific requirements

Certificate of Analysis (COA) - available on request

Safety Data Sheet (SDS) – available on request

Ordering

Name

Source

Form

Part Code

Normal Human Serum

Human plasma

Frozen liquid

SF-0001

Name

Normal Human Serum

Source

Human plasma

Form

Frozen liquid

Part Code

SF-0001

For more information on our IVD Raw Materials

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