SOP Title: Coding, Utilisation and Cleaning of Accessories

SOP Title: Coding, Utilisation and Cleaning of Accessories

 

1. Objective:

To lay down procedure for Coding, Utilisation and Cleaning of Accessories.

2. Scope:

This SOP is applicable to all Accessories used for production activities in Production Department.

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for Coding, Utilisation and Cleaning of Accessories.
   • Quality Assurance Department: To review and approve the SOP and Annexes. To ensure compliance of the SOP.
4. Accountability:

Head, Production and Head Quality Assurance Department

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance department or any personnel trained to perform duties as per this SOP.
     • Accessories: Includes Bin, Scoops, Spatula, Spoons, Jug/Jar, Container, Bowl, Sampling Device, Sample collection containers etcetera, which are used for production activity in Production Department.
     • Type A Cleaning: Dry cleaning with clean lint free cloth/ Vacuum Cleaner and removing the previous batch powder/material in the following cases:
       • Remove the previous batch material.
       • During end of the shift.
       • Before starting the next batch of the same product.
     • Type B Cleaning: Wet cleaning using water and/or cleaning agent which includes removal of traces of the previous product and ensured by visual inspection of cleaned equipment in the following cases:
       • Change in next product or
       • Prior to execution of lower strength batches subsequently to higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After each seven days of cleaning, if equipment is not in use.
       • Monthly, if the cleaned Accessory is not used for production activity.
       • Change in colour, if next product is same
     • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
   • Procedure

	Precautions
5.2.1	All newly received accessories are to be cleaned as per Type B Cleaning procedure and check for quality as per requirement.
5.2.2	Any damaged accessory should be immediately removed from the production usage and record should be maintained in inventory record.
5.2.3	Coding of Accessories:
5.2.3.1	All new received accessories are to be checked for its quality and design as per requirement then clean before use.
5.2.3.2	Inventory to be maintained every month in “Accessories Inventory Record” as per SOP.
5.2.3.3	Damaged accessory should not be used for production activity and that particular code number to be made obsolete with remark, on inventory record.
5.2.3.4	All accessories are to be coded section wise as per below given pattern.
5.2.3.5	Coding of accessories: Sr. No. Name of accessory Coding pattern 01 Tool Box TB 02 Table TL 03 Bowl BL 04 Spoon SP 05 Accessory Box AB 06 Scoops SC 07 Waste Bin WB 08 Dust Bin DB 09 Document Stand DS 10 Gloves Box GB 11 Ladle LD 12 Jug /Jar JG 13 Bin BN
5.2.3.6	Area codes to be used for accessory coding: For Granulation  Section              : GRN Compression Section             : COM Coating Section                     : COA Capsules Section                   :  CAP Packing Section                     :  PKG For example: Scoop of granulation section : SC/COA/01 Accessory name / Section / Serial number SC – for Scoop, COA – for Coating 01 for Serial number
5.2.4	Usage of Accessories for Production activity
5.2.4.1	Use coded accessory dedicated area wise.
5.2.4.2	Before use, ensure that the Accessory is clean and dry.
5.2.4.3	After usage label the accessory as “To BE Type A Cleaned” or “To BE Type B Cleaned” label as per requirement.
5.3	Cleaning of Accessories Used for Production Activity
5.3.1	Type A Cleaning
5.3.1.1	Clean inside and outside of accessory with dry clean duster. Note: If the accessory has been used for the liquid/semi solid material, then clean the accessory with potable water finally with purified water.
5.3.1.2	Ensure the cleanliness and label the Accessory as “Type A cleaned”
5.3.1.3	Transfer the cleaned Accessory to the respective area.
5.3.1.4	Record the cleaning activity in “Utilisation and Cleaning Record of Accessories” as per Annexure.
5.3.2	Type B Cleaning
5.3.2.1	Clean inside and outside of container with dry clean duster/ vacuum cleaner.
5.3.2.2	Wash the Accessory with 0.1% soap (Teepol) solution by scrubbing with nylon scrubber.
5.3.2.3	Then wash with sufficient quantity of potable water till it is visibly clean for absence of powder / dust.
5.3.2.4	Finally rinse with purified water.
5.3.2.5	Wipe the Accessory with dry clean duster to remove the traces of water and dry clean with compressed air/in tray dryer.
5.3.2.6	Label the Accessory as “Type B Cleaned” .
5.3.2.7	Record the cleaning activity in “Utilisation and Cleaning Record of Accessories” as per Annexure.

 

6. Abbreviation :

Abbreviation	Expansion
SOP	Standard Operating Procedure
%	Percentage
v/v	Volume By Volume
ml	Millilitre
PD	Production Department
No.	Number

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.