SOP on sterilization of garment and surgical hand gloves

November 23, 2016January 2, 2024 Pharma Editor

Objective
To lay down a procedure for sterilization of garments and surgical hand gloves.
Scope
This SOP is applicable for sterilization of garments and surgical hand gloves.

Responsibility
Production Officers /Executive.
Accountability
Production Head shall be accountable for the compliance of SOP.

Abbreviations
SOP : Standard Operating Procedure.
LAF : Laminar Air Flow

Procedure
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 ⁰C / 5 min
05.	Heat up 2 / Hold 2	115.0 ⁰C / 5 min
06.	Heat up 3 / Hold 3	118.0 ⁰C / 4 min
07.	Heat up controlled band	0.2 ⁰C
08.	Sterilization hold temperature	122.0 ⁰C
09	Sterilization hold time	25 min

10.	Temperature control band	0.2 ⁰C
11.	Overshoot temperature	124 ⁰C
12.	Sterilizations stop temperature	120.9 ⁰C
13.	Sterilization reset temperature	120.5 ⁰C
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 3^rd

Store the sterilized garment and surgical hand gloves sets in garment cubicle.

Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History

Date Revision Number
Reason for Revision

– 00 New SOP

Production Aberdeen, Aberdeenshire, Abu Dhabi, Abu Dhalouf, Abu Hamour, Abu Samra, ABUJA, ACCRA, Acre, Ad Dawhah al Jadidah, ADDIS ABABA, Adelaide, AFGHANISTAN, Agra, Agrigento, Ahmedabad, Aïn Beïda, Ain Khaled, Ain Sinan, Ajman, Ajman and Ra’s al-Khaimah, Ajmer, Al Ain, Al Aziziya, Al Bidda, Al Daayen, Al Dafna, Al Ebb, Al Egla, Al Gharrafa, Al Ghuwariyah, Al Hilal, Al Jasrah, Al Jeryan, Al Karaana, Al Kharaitiyat, Al Kharayej, Al Kharrara, Al Kheesa, Al Khor, Al Khulaifat, Al Luqta, Al Mamoura, Al Mansoura, Al Markhiyah, Al Mashaf, Al Masrouhiya, Al Mearad, Al Messila, Al Mirqab, Al Najada, Al Nasraniya, Al Qassar, Al Rufaa, Al Sadd, Al Sailiya, Al Sakhama, Al Seej, Al Shagub, Al Souq, Al Tarfa, Al Thakhira, Al Themaid, Al Thumama (Al Wakrah), Al Thumama (Doha), Al Utouriya, Al Waab, Al Wajba, Al Wakrah, Al Wukair, Al Zubarah, Al-Shahaniya, Alagoas, ALBANIA, Alberta, Alessandria, ALGERIA, Algiers, Aligarh, Allahabad, Allerdale, Amapa, Amazonas, Amber Valley, Amersham, AMMAN, 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