• Tabletten

    GOOD TO KNOW

    that elemental analysis helps
    to ensure product quality

     

     

Organic Elemental Analysis Applications within the Pharmaceutical & Fine Chemicals Industries

Elemental analysis for the elements Carbon, Hydrogen, Nitrogen, Sulphur and Oxygen have a number of applications at every stage of the manufacturing process. Due to this Elementar have created a number of Data Bulletins addressing the specific requirements of these users.

Before:

It is critical to confirm that the raw materials used to manufacture a product are of the correct specification. One example of this is the water used in these processes. Total Organic Carbon (TOC) testing is a quick and cost effective method of performing this. As high purity water is used very low detection limits need to be achieved reliably.

For more information view the following Data Bulletin:



During:

Calculating the ratio of the elements CHNS is a quick, easy way to determine the compound purity of a product. The ease of sample preparation, speed of analysis and instrument robustness make it suitable for a quick screening method. If impurities are found more laborious chromatographic methods, such LC-MS, may then be employed to identify the cause of the impurity. The analysis of Oxygen can also be used for the same purpose, however, as it cannot be determined simultaneously with CHNS it is less commonly performed.

For more information view the following Data Bulletins:



After:

Once a batch of products have been manufactured a cleaning procedure is performed before the equipment can be used for subsequent batches. TOC testing again is a vital tool to validate whether the cleaning process has been completed successfully. By determining if the cleaning fluid used to rinse the cleaned vessel contains any residual organic carbon indicates if any contaminants remain in the vessel. The majority of this analysis is performed on liquid samples, however often solid sampling is needed to analyse swabs taken from the vessel surfaces.

For more information view the following Data Bulletins:



Compliant to 21 CFR Part 11

In addition to the demanding detection limits these industries require within the Pharmaceutical industry all equipment must be able to be operated to 21 CFR Part 11 criteria. All the Elementar instruments can be operated in a compliant manner using a software written for this purpose.

 

For further information or if you have any questions, please do not hesitate to contact us.

Elementar UK Ltd. - Isoprime House - Earl Road - Cheadle Hulme - Stockport - SK8 6PT
Phone: + (44) 161 488 3660 - Fax: + (44) 161 488 3699 - Email: info[a]elementar.co.uk