SOP for operation and cleaning of Sterile garment cubicle

November 25, 2016February 3, 2023 Pharma Editor

Objective:
To lay down a procedure on operation and cleaning of sterile garment cubicle.
Scope
This SOP is applicable for the operation and cleaning of sterile garment cubicle.
Responsibility
Officers or above – Production.
Accountability
Production Head.
Abbreviations
SOP : Standard Operating Procedure.
LAF : Laminar air flow
U.V. : Ultra violet

Procedure
Operation:
Sterile garment cubicle is installed between the change room and cooling zone of sterile area and is used to keep the sterile garments, sterile mopes and goggles.
Switch on the blower and U.V. light from the front panel switches, 30 minutes before the start of activities.
Check the interlocking of doors is working properly.
Ensure that megnehelic gauge reading is within the specified limits of 8 to 15 mm of water.
To load the sterile dress/goggles/sterile mopes press the door open switch on the front panel of the cubicle from the cooling room side.
After loading close the doors of the cooling room side.
To unload the sterile dress/goggles/sterile mope press the door open switch on the front panel of the cubicle from the third change room side.
After unloading close the doors of the third change room side.
Record the UV burning hours and differential pressure in the format (specimen attached with Annexure-1).
Cleaning of the garment cubicle.

Cleaning of the sterile garment cubicle is to be done daily before the start of activities.
Remove any material from the sterile garment cubicle.
Clean and sanitize the entire sterile garment cubicle with lint free mope soaked in 20 % verosil pharma.
In case of any material is to be kept in the garment cubicle, wait for at least 30 minutes before loading it.
Check the differential pressure and if found outside the limits (8 mm to 15 mm of water) clean the pre filters as per SOP on cleaning of Pre-filters of LAF Unit ,Garment cubicle, Dynamic pass box.
Forms and Records (Annexures)
Record of differential pressure and Burning hours of U.V Light (Sterile Garment cubicle) – Annexure-1
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History

Date Revision Number
Reason for Revision

– 00 New SOP

Annexure-1

Record of differential pressure and Burning hours of U.V Light (Sterile Garment cubicle)

Date

Differential pressure

In mm of water

No of hours burnt

Cumulative hours burnt

Done by

Checked by

Remarks

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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