| Cleaning of HPLC vials |
| 1.0 PURPOSE 1.1 To Define procedure for Cleaning of HPLC vials in quality control department. 2.0 SCOPE 2.1 This procedure for Cleaning of HPLC vials in quality control department. 3.0 REFERENCE(S) & ATTACHMENTS 3.1 In house 3.2 Attachments 3.2.1 NA 4.0 RESPONSIBILITY 4.1 Quality control Officer/ Executive: 4.1.1 To initiate the preparation of Standard operating procedure through the inputs from the employees directly concerned with the activity. 4.1.2 To prepare the SOP and list of all assigned numbers of the SOP for their departments. 4.2 Quality Control Head: 4.2.1 To confirm the content, accuracy and detailing about of SOP. 4.2.2 To organize the approval of SOP from Quality assurance (QA head) and Location Head. 4.2.3 To ensure the training of the SOP to all concerned involved in implementation of the SOP. 4.2.4 To ensure user the implementation of the SOP after training. 4.3 Quality Assurance Department 4.3.1 To check the SOP and maintain the original copy of the SOP. 4.3.2 To issue controlled copy of the SOP and maintain issuance record of SOP. 4.3.3 To retrieve the controlled copy of the SOP when it is superseded/obsolete. 4.3.4 To control and monitor the review process of the SOP. 4.4 Quality Assurance Head & Location Head 4.4.1 To review and approve SOP. 4.4.2 To ensure the implementation of the defined system in quality control department. 5.0 DISTRIBUTION 5.1 Quality control department 6.0 ABBREVIATION(S) 6.1 SOP : Standard Operating Procedure 6.2 QA : Quality Assurance 6.3 QC : Quality Control 6.4 No. : Number 6.5 NA : Not Applicable 7.0 PROCEDURE 7.1 Open septa of all used vials. 7.2 Empty the vials by drain waste in beaker, collect waste and drain in sink at washing area in excess of running water. 7.3 Rinse all vial and septa with purified water and place in beaker separately. 7.4 Pour methanol 100 % in both beakers. 7.5 Place beakers on sonicator and sonicate for 15 minutes. 7.6 After sonication remove vial and septa from beaker and rinse with purified water and dry in oven at 60° C for one hour 7.7 Cover vials and septa separately in aluminium foil and place at dedicate location for use. |
