High quality TOC standard substance - self prepared VS. Purchase finished products
Date: 2025-09-18Read: 34
As a quality control (QC) expert, you need to rely on effective analytical data to make relevant decisions, including how toComply with strict regulatory requirements, develop compact production plans, and reduce operating budgetsThe reliability of data analysis is based on the following elements:
Competent employees
Strictly adhere to standard operating procedures (SOP) and regulatory requirements
Effectively confirm and maintain good instruments
Traceable and qualified standard items and consumables
With the increasing demand for lean and efficient experimental processes, more and more QC experts are seeking excellent suppliers to provide one or more key projects. Using a Third Partyreference materialThe TOC standard is a good example. By outsourcing time-consuming cleaning, configuration, document production, and recording tasks to a trusted high-quality manufacturer, QC experts can focus more on their job responsibilities or achieve departmental goals.
Evaluate the cost of internal self-made standard products
Sievers®Compared to in-house standard products, TOC standard products can save significant costsAnd its advantages are not only reflected in cost. Standard samples with low TOC background require very complex pollution control strategies to meetultrapure waterThe performance level of the application cannot always be met by self-made standard products. The biggest challenge faced in successfully providing standard samples with low TOC background is as follows:
Cleanliness and specificity of glassware
Skilled, trained, and consistently performing technical personnel
Purity of blank water and raw materials
Cleanliness of sample bottles, bottle caps, and gaskets
Any number of factors can lead to the failure of standard products, resulting in out of specification (OOS) investigations and potential production delays. By using Sievers certified standards, usersIt can reduce the burden and risk brought by self-made standard productsThis includes maintaining the necessary equipment, training, and material supply chain. If the analysis or standard verification fails, Sievers' 'Fault Analysis Report' can help users reduce liability risks and quickly supplement Out of Specification (OOS) investigations.
When deciding whether to make homemade or purchase ready-made TOC standard products, the following four cost factors can be used as references:
The labor and material costs required for cleaning glassware, solution preparation, equipment calibration, peer review, and completing documents consistent with Good Documentation Practice (GDP)
Arrange laboratory personnel to prepare standard products, rather than the opportunity cost of executing other key laboratory projects
The cost of losses caused by production delays or reduced laboratory output due to the failure of internally produced standard products
The risk cost associated with assuming all responsibility for producing traceability documents that comply with the International System of Units (SI)
The following table presents the material and labor costs that can be saved by using Sievers standards instead of self-made standards. This analysis compares the cost of conducting weekly or monthly system suitability standard product testing for users, and similar comparisons can also be extended to other standard products. For more information, please contact your local after-sales service representative.
Using Sievers®Expected cost savings from system suitability standards
Labor cost plus management cost
Assuming the shelf life of a 100 ppm solution is 4 weeks
Estimated cost of other miscellaneous materials required
Assuming that three Out of Specification (OOS) surveys are conducted annually
Including transportation costs
Sievers certified standards can save significant costs, provide high-quality analysis results, and offer valuable support to users in the event of Out of Specification (OOS) incidents.Outsourcing the production of standard products to Sievers allows internal laboratory resources to focus on valuable projects and opportunities specific to the company.
