- To lay down a procedure for sterilization of garments and surgical hand gloves.
- This SOP is applicable for sterilization of garments and surgical hand gloves.
- Production Officers /Executive.
- Production Head shall be accountable for the compliance of SOP.
- SOP : Standard Operating Procedure.
- LAF : Laminar Air Flow
- Controlled Area Operation
- Load the trolley with garment bags as per the attached, validated loading pattern.
- Operate the sterilizer as per SOP.
|S.No.||Parameters||Set value in cycle|
|01.||Pre vacuum||-0.500 bar|
|02.||Pre pressure||0.500 bar|
|03.||No. of pre pulses||3 no.|
|04.||Heat up 1 / Hold 1||110 0 C / 5 min|
|05.||Heat up 2 / Hold 2||115.0 0 C / 5 min|
|06.||Heat up 3 / Hold 3||118.0 0 C / 4 min|
|07.||Heat up controlled band||0.2 0 C|
|08.||Sterilization hold temperature||122.0 0 C|
|09||Sterilization hold time||25 min|
|10.||Temperature control band||0.2 0 C|
|11.||Overshoot temperature||124 0 C|
|12.||Sterilizations stop temperature||120.9 0 C|
|13.||Sterilization reset temperature||120.5 0 C|
|14.||Post vacuum||-0.700 bar|
|15.||Vacuum hold time||15 min|
|16.||Post pressure||-0.100 bar|
|17.||No. of post pulses||3|
|18.||Process end pressure||-0.050 bar|
|19.||Exhaust on||5 sec|
|20.||Exhaust off||55 sec|
- On Completion of the cycle, check the cycle thermograph against the Master chart for garments and hand gloves load, for Temperature and time during the sterilization hold.
- Check the temperature control chart for the steam sterilization cycle parameters.
- No. of Vacuum Pulses : 03
- Vacuum for Pulsing : -0.500 bar
- Steam Pressure for Pulsing : 0.500 bar
- Sterilization Temperature Range : 121 to 124 degree centigrade
- During Sterilization Hold Period
- Sterilization Hold Time : 25 minutes
- Sterilization pressure during : Not Less Than 1.110 bar
- Sterilization hold time
- Vacuum Cycle : 45 minute
- If the thermograph of the cycle matches the Master chart, inform the Aseptic area Personnel for unloading of the Sterilized garments and hand gloves. Attach the thermograph in the Batch Production Record (BPR).
- If the thermograph does not match the Master chart the cycle will be considered. Do not unload the garments and hand gloves in the Aseptic Area. Repeat the sterilization cycle. Inform the deviation to the Quality Assurance Department. Carry out the further processing as per the suggestions from the quality assurance.
- Record the cycle details of Operation in the Equipment Log book as per SOP and the Batch production record, get it checked by the Concerned Officer
- Aseptic area operation
- Unload the trolley in cooling zone (class 100 area) containing the sterilized garments and the hand gloves.
- Transfer the sterilized bags & surgical hand gloves to double door garment cubicle in aseptic change room 3rd
- Store the sterilized garment and surgical hand gloves sets in garment cubicle.
- Forms and Records (Annexures)
- Not Applicable
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number
Reason for Revision
– 00 New SOP