SOP on Receipt, Identification, Performance, Utilization And Destruction of HPLC Column

Purpose

This SOP describes the procedure for receipt, identification, performance, utilization and destruction of HPLC column.

Scope

This SOP is applicable for Receipt, Identification, performance, utilization and destruction of all type of HPLC column of Research and Development Center at “ABC Limited”

Procedure:

Column  

Procurement and receipt of HPLC Column 

• Analyst ADL shall raise the “purchase Requisition” of required column as per the requirement for analysis and same shall be approved by department head.
• On receipt of new column or column transferred from the other location, check   the column for its suitability with respect to dimension, particle size, stationary phase against the “Purchase requisition” or details given by the supplier and the certificate of analysis” received with the column.
• Reject the column if any of the above mentioned parameters is not complying.
• If the column is completely matching to requirement, make an entry in to column Receipt Book and keep it under security with lock and key provision.

Allocation of Identification No. to HPLC column:

Column identification no. is having 14 characters i.e.  First three characters represent company name while fourth, eight and eleventh characters showing   slash “/”. Fifth, Sixth and seventh characters Nine and Tenth characters are HC. Twelve, Thirteen and Fourteen character represents the sequential serial no.  001, 002,003 . . .

Make an identification label and paste on the same column. Make its entry in the column receipt records

Performance of columns:

Before usage of new columns check the following parameters:

Theoretical plates, retention time, tailing factor and any other required parameters.

Details of the same shall be recorded in “Column Performance Record”

Issuance and Utilization of columns:

Issue the column for routine analysis in lab and maintain the cumulative record of injection month wise,

Destruction of HPLC column:

• During the usage of column, reject the same if following abnormalities are observed:
• System suitability requirements of the product under analysis are not met.
• Broadening of the peak observed.
• Splitting even after frit cleaning and washing.
• The rejected HPLC column shall be bent to avoid its further use and scrapped. The details of the same shall be recorded in “Column Destruction Record”