STANDARD OPERATING PROCEDURE MAINTENANCE OF QA EQUIPMENT

STANDARD OPERATING PROCEDURE

SUBJECT :                     MAINTENANCE OF QA EQUIPMENT

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines for the maintenance of QA equipment.

2.0       POLICY:  

To lay down a procedure for maintenance of QA equipment.

3.0       PROCEDURE:

3.1       HPLC Preventive Maintenance

The following Components of the HPLC are to be regularly cleaned and maintained

3.1.1    FILTERS

           

            Procedure to be followed:

            Please use Gloves before handling the component.

Detach the filter from the Tubing. Boil in 6N Nitric acid for about half an hour. Then wash the filter with boiling water (HPLC grade) .Wash with water for 4 times and check the pH of water with pH paper, if found acidic continue washing until pH is neutral. Finally rinse the filter with Methanol (HPLC grade).Replace the Filter to the tubing and purge the tube to remove air gaps.

Frequency: Once a Month.

3.1.2    COLUMNS:

Column maintenance is done by carrying out Column Regeneration & Proper Storage

3.1.2.1 For C18, C8 Columns: Regeneration and storage is done by the following Method:

Flow Rate: 1ml/min.    Time: 50 min/solvent.

The Solvents mentioned here under are used in the Sequential order. Solvents of       HPLC   grade are to be used.

WATER, METHANOL, ACETONITRILE, TETRA HYDROFURAN, ACETONITRILE, METHANOL         

3.1.2.2 Regeneration Frequency: After the completion of testing Schedule regenerate the column and record in log book. After the Column is Regenerated Store the Column in METHANOL and plug the Column.

3.1.2.3 Benylin & Silica Columns Regeneration & Storage is done by the following method:

           

Flow Rate: 1ml/min.                Time: 50min/Solvent.

The Solvents mentioned here under are used in the Sequential order. Solvents of       HPLC grade are to be used.

                       

HEXANE

METHYLENE CHLORDIE

            ISOPROPYL ALCOHOL

            METHYLENE CHLORIDE

            ISOPROPYL ALCOHOL

3.1.2.4 Regeneration Frequency: After the completion of testing Schedule regenerate the column and record in log book. After the Column is Regenerated Store the Column in ISOPROPYL ALCOHOL and plug the Column.

Important Precaution: For Silica column do not use water for cleaning.

3.1.2.5 Phenyl Columns: Regeneration & Storage is done by the following method:

Flow Rate: 1ml/min.    Time    : 50min/Solvent.

The Solvents mentioned here under are used in the Sequential order. Solvents of       HPLC   grade are to be used.

                       

WATER with 0.5 ml DIMETHYL SULFOXIDE

            METHANOL

            CHLOROFORM

            METHANOL

3.1.2.6 Regeneration Frequency: After the completion of testing Schedule regenerate the column and record in log book. After the Column is Regenerated Store the Column in METHANOL and plug the Column.

3.1.2.7 DAILY CLEANING OF THE COLUMN: After the day’s work is completed the column is to be washed for 45minutes with water (HPLC grade), METHANOL and stored in METHANOL.

3.1.2.8 PUMP AND DETECTOR maintenance is done by the Authorized Engineer of WATERS (INDIA) LTD. as the Equipment is covered under Annual Service

    

3.2       BALANCE:

3.2.1    Balance Maintenance:

            Balance platform should be cleaned with tissue paper.

            Balance pan should be cleaned regularly with Methanol.

            Glass panes should be cleaned.

3.2.2    Preventive measures:

            Do not weigh material exceeding the capacity of the Balance.

            Do not weigh Corrosive, hot and cold substances.

            Handle the Balance with care.

3.3       UV VISIBLE SPECTROPHOTOMETER:

            Clean the equipment using muslin cloth.

            Cuvettes are to be cleaned with chromic acid once a month.

            After using the Equipment place Silica gel bags in the Sample compartment.

            Handle the cuvettes with care.

            Do not measure absorbance of Hot, Cold, and Fuming & Corrosive material.

3.4       MICROSCOPE

Use cover slips to cover sample on the slide.

            Clean the plates thoroughly for future use.

            Do not remove the Eye piece.

            Handle the Microscope with care.

            Clean the sample platform & eyepiece regularly with muslin cloth.

4.0       FREQUENCY:  Cross check daily before use & Calibrate once in 3 months.

5.0       RESPONSIBILITY:   Executive Q.A.

6.0       REVIEW GUIDE:  Log book.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x