sop for Cleaning and Handling and Silicone Tubes
1.0 OBJECTIVE:
To lay down the procedure for Cleaning and Handling of Silicon Tubes.
2.0 SCOPE:
This SOP is applicable for Cleaning and Handling of Silicon Tubes and to ensure that such are handled before and after filling in proper manner in to the Production area
3.0 RESPONSIBILITY:
Officer / Executive – Production
4.0 ACCOUNTABILITY:
Head – Production
5.0 PROCEDURE:
5.1 NUMBERING SYSTEM OF SILICON TUBING:
5.1.1 Each set of Silicon Tubes shall have unique identification number and control by purpose and generic product wise. Once a number is allocated to any set of silicon tubes shall not be repeated to any other set of silicon tubes.
5.1.2 Enter the receipt detail of silicon tube with ID No. shown in Annexure-I.
5.1.3 Each set shall be consist of 9 alphanumeric characters
5.1.4 Prepare Silicon Tube Status Label as per format shown in Annexure-II.
5.2 CLEANING OF SILICON TUBE:
5.2.1 Before use of fresh Silicon tubing used for the product filling shall be send for washing and sterilization room through pass box in washing area.
5.2.2 Wash and rinse the Silicon Tube with sufficient quantity of purified water.
5.2.3 After that wash and rinse the Silicon Tubing with sufficient quantity of water for Injection (WFI) followed by dry the silicon tube with 0.2µ filtered compressed air.
5.3 HANDLING AND STORAGE OF SILICON TUBE:
5.3.1 Issued the silicon tube as per the requirement.
5.3.2 After cleaning & sterilization of silicon tube unload under LAF and transfer through mobile LAF to aseptic filling area for assembling.
5.3.3 After completion of filling & sealing activity, transfer the silicon tube to the pre wash room, cleaned the silicon tube and dry with air & return to storage area.
5.3.4 Wrap the both end of tubes with parchment paper and keep in double polybag with proper status label in respective SS locker.
5.3.5 Discard the silicon tube after use of 30 sterilization cycle or whenever any change in colour or damage.
5.4 Usages of silicon tubes shall be recorded as per format Shown in Annexure-III.
6.0 ABBREVIATION:
SOP :Standard Operation Procedure
WFI : Water for Injection
LAF :Laminar Air Flow
SS :Stainless steel
QA :Quality Assurance
7.0 ANNEXURES:
Annexure-I : List of Silicon Tube
Annexure-II :Identification Tag
Annexure-III : Silicon Tube Log Book
Annexure-II
Annexure-III
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Good knowledge