This document describes the procedure for purchase, installation, storage, performance evaluation, usage, cleaning and withdrawal of GC columns.
PURPOSE :
This document describes the procedure for purchase, installation, storage, performance evaluation,usage, cleaning and withdrawal of GC columns.
II. SCOPE :
Applicable to all GC columns used in the Quality Control department
III. RESPONSIBILITY :
It is the responsibility of the Quality Control personnel involved in the usage of GC columns, to follow the procedure as mentioned in this Standard Operating Procedure.
IV. DOCUMENT REFERENCE :
SOPs : None
Forms : Column inwards register, Column performance work book & tag.
V. PROCEDURE :
1.0 PURCHASE OF COLUMNS :
1.1 Indent & receive the columns from Purchase department and verify whether correct columns are received against to specify the column make, brand name, dimensions and particle size.
1.2 Check the column for physical damage, which may have occurred during shipping.
2.0 INSTALLATION OF COLUMNS
2.1 Retain safely the column performance certificate sent by the manufacturer.
2.2 Ensure that the column ends are securely closed.
2.3 Store the column in the designated area.
2.4 Test the column immediately to verify quality and allot individual.
3.0 COLUMN PERFORMANCE EVALUATION
3.1 Prior to column performance, condition the column for at least 2 hrs by slowly increasing the temperature in steps.
3.2 Test the column for performance by the following procedure:
3.3 Preparation of standard solution :
Pipette out 2 mL of Methanol, 2 mL of Ethyl alcohol and 1mL of IPA in a 100mL volumetric flask make up the volume with organic free water up to the mark. Further dilute 5 mL of this solution to a 50-mL volumetric flask and dilute up to the mark with organic free water
3.4 GC Conditions
Carrier gas : Nitrogen
Flow rate : About 4 mL/min
Detector : FID
Column temperature : 50°C
Injector temperature : 140°C
Detector temperature : 260°C
Injection quantity : 1 mL using head-space
3.5 Head space conditions
Incubation temperature : 85°C
Incubation time : 15min
Injection volume : 1mL
Syringe temperature : 105°C
Temperature delay after pull up : 0 min
Plunger feed filling strokes : 50ul/s
Fill speed : 200ul/s
Preinj.delay : 0min
Post inj. Delay : 0 min
3.6 Pipette out 5 mL of standard solution into six 20 mL individual headspace vials having 1 g each of anhydrous sodium sulphate and inject for six times.
3.9 When the chromatograms are recorded in the prescribed conditions, the order of elution is ethyl alcohol, Methanol and IPA.
3.10 Calculate the % RSD for the areas and Retention times of Ethyl alcohol, Methanol and sopropyl alcohol from six replicate injections of standard solution.
Acceptance criterion:
a) The %RSD for the areas of Ethyl alcohol, Methanol and Isopropyl alcohol
Obtained from the six replicate injections should be less than 15.0
b) The %RSD for the Retention times of Ethyl alcohol, Methanol and Isopropyl alcohol
Obtained from the six replicate injections should be less than 2.0
4.0 WITH DRAWAL OF COLUMNS :
4.0 Withdraw the column from usage in case of any of the following instances:
4.1 Physical damage
4.2 Failure to comply system suitability requirements as per specification .( Note: When failure to the system suitability requirements as per specification, evaluate once again the column performance and take the decision of withdrawal )
4.3 Failure to comply with performance check requirements.
4.4 Indicate the withdrawal on the column inwards register and update the column index.
Gc columns, installation, storage, performance evaluation
