(C)RM document explanation

(C)RM Document explanation

This guide explains the two types of product documents issued by Biosisto and how to interpret the information they contain. It is intended to help users identify the correct document and understand the reported values and product information.

There are two types of product documents at Biosisto, a Product Information Sheet and a Reference Material Certificate. The table below explains the purpose of each document and the information you can expect to find in it.

Document	Explanation
Reference Material Certificate	Issued for certified reference Materials (CRMs). This document contains the essential information for the use of a CRM, confirming that the necessary procedures have been carried out to ensure the validity and metrological traceability of the stated strain(s) and/or property values.
Product Information Sheet	Issued for qualitative and quantitative reference materials (RM). It contains the information required for the proper use, storage, handling, and interpretation of the material. Therefore, containing all the information that is essential for using a RM.

Information bar

The first section of the document provides the key information needed to identify the product, batch and applicable document version. Use these details to confirm that the document belongs to the material you received and that you are using the current version.

Term	Explanation
Product	The commercial name of the product.
Batch	The unique identifier linking the product, document and production batch.
Production date	The date on which the batch was produced.
Biosafety level	The containment level indicated for handling the material. Follow your organisation’s risk assessment and safety procedures.
Batch expiry date	The date up to which Biosisto guarantees that the batch can be used when stored and handled as instructed.
Document version	The revision number of the document.
Document date	The date on which the document was authorised or issued.
Document active	Shows whether the version is current.

Strain information

This section provides information about the microorganism contained in the reference material and, where applicable, its recognised source. These details help you verify the identity and origin of the strain.

Term	Explanation
Strain	The scientific name and, where applicable, the strain designation used to identify the microorganism.
Certified	Certified strains are traceable to a WFCC recognized culture bank.
Culture collection	The recognised collection or source from which the strain originates, where applicable.
WDCM strain number	A globally used identifier that can link a strain to a culture collection entry, where applicable.

Property values

The property values section indicates which characteristic of the microorganism was analysed and how the reported result was determined. Depending on the type of reference material, the table contains information on the property value, standard deviation, measurement uncertainty, test method, and culture medium.

Property value (PV) and standard deviation (SD) can be used for the limits of the startup control chart.
The Upper Control Limit (UCL) = PV + 3 * SD
The Lower Control Limit (LCL) = PV – 3 * SD

Term	Explanation
Analysis for /measurand	Identifies the property, quantity or qualitative attribute for which information is reported. In practical terms, it tells you what was measured or identified.
Certified	Shows whether the property on that specific row is certified. Which means that the traceability for the property value is accomplished by analysis through a network of laboratories.
PV	The PV represents the unweighted mean cfu/ml from a statistically relevant number of samples. Depending on the value assignment approach, the PV can be derived from homogeneity studie, internal characterization generated by Biosisto or external characterization data obtained from external laboratories and Biosisto.
SD	Standard deviation of the results used in the evaluation of the reported property value.The SD is based on historical data, if this is not available a default value of 25% RSD is used.
Uc	The expanded standard uncertainty is based upon at least one batch of the same product with two years of storage. The Uc is calculated as the square root of the sum of the individual contributions. The Uc has a coverage factor of 2, which means a 95% confidence level; 95% of the analyses results should fall within PV ± Uc
Standard	The standard, measurement procedure or test method used to determine the reported value.
Media	The culture medium used when determining the reported value.

Additional information

The final section explains how the reference material should be stored, prepared and used. It also contains relevant safety information and shows how the document has been authorised. Always follow these instructions to ensure that the material remains suitable for its intended use.

Term	Explanantion
Description	The product format, relevant preparation information and the conditions under which the material must be stored to maintain validity.
Instructions	Instruction to use the product, supplemented with the Biohazards safety level. In addition, please refer to the Safety Data Sheet, which is available on our website.
Authorization	The undersigned name and signed date. Accredited products show the logo of The Dutch Accreditation Council (RvA). The production of accredited products is in accordance with ISO 17034.

Questions regarding the interpretation of this document can be directed to Biosisto via info@biosisto.com.