Sampling Tools Cleaning and Storage; Purpose:
Sampling Tools Cleaning and Storage; The purpose of this procedure is to describe the instruction of cleaning and storage of sampling tools.
Sampling Tools Scope:
This SOP is applicable to sampling tools used for Quality Control Laboratory and Microbiology Laboratory at XX Pharmaceuticals Ltd.
Definitions/Abbreviation:
[][]SOP: Standard Operating Procedure: A written authorized procedure, which gives instructions for performing operations.
[][]QC: Quality Control.
Responsibilities:
[][]The roles and responsibility is as follows:
[][]Laboratory Attendant, QC & Microbiology
[][]To prepare of cleaning solution.
[][]To clean and store all sampling tools by following SOP.
[][]Executive, QC & Microbiology
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Manager, Quality Control
[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]Arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.
Head of Quality Assurance
[][]Approval of the SOP.
[][]To ensure overall implementation of this SOP.
Procedure:
Precaution(s):
[][]Wear hand gloves, mask and protective clothing before cleaning of sampling tools.
[][]Be sure that the sampling tools are cleaned just after use.
[][]After cleaning of tools, be sure that the tools are free from any residual content of detergent or sample.
[][]During handling, sterilized gloves should be worn after sterilization of microbiology sampling tools.
Cleaning of Sampling Tools:
For scoop/spoon:
[][]Clean the sampling devices with potable water following by 0.5% soap or detergent solution.
[][]Finally rinse with purified water to remove the adhering material.
[][]Check the cleanliness physically and clean again if necessary.
[][]Dry in hot air oven for use in QC sampling.
[][]Sterilize at 2000C for 1 hour or autoclave at 1210C for 15 minutes for the sampling of Microbiology analysis.
For pipette (glass) and Glass Rods:
[][]Pass the running potable water through the pipette to remove the adhering material.
[][]Sink the pipette into 0.5% soap or detergent solution.
[][]Rinse with potable water to remove detergent.
[][]Finally rinse with purified water.
[][]Confirm that the tools are cleaned properly, clean again if it is necessary.
[][]Dry in hot air oven for use in QC sampling.
[][]Sterilize at 2000C for 1 hour or autoclave at 1210C for 15 minutes for the sampling of Microbiology.
Storage of Sampling Tools:
[][]After dry, remove the cleaned tools from the oven and wrap the dry tools individually with cleaned polybag.
[][]Ensure that there is no exposure of sampling tools after wrapping the cleaned dried tools with polybag.
[][]Finally keep it at closed condition.
[][]Affix the tag “CLEANED” label duly signed with date on the sampling tools.
[][]Use the tools within 7 days sampling of Chemical test and within 24 hours for sampling of microbiology test.