Entry and Exit in Microbiology Sterile Area

1.0 Objective
To lay down a procedure for Entry and exit in microbiology sterile area.
2.0 Scope
This Standard Operating Procedure is applicable for the procedure for Entry and exit in

microbiology sterile area to be followed at Quality Control Department of abc company,
3.0 Responsibility
3.1 Concerned Officer/Executive shall be responsible to follow this SOP.
3.2 Department Head or his designee shall be responsible to implement and ensuring to compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
LPG : Liquefied Petroleum Gas
Q.C : Quality Control
IPA : Iso Propyl Alcohol
No. : Number
UV : Ultraviolet
5.0 Procedure
5.1 Entry
5.1.1 Sterile area entry has got three Air locks. Air lock-1, Air lock-2 and Air lock-3.
5.1.2 Only authorized Officers/Executive and listed staff is allowed to enter in to Microbiology sterile area.
5.1.3 Every entry shall be written in the log book as given in the Annexure-1.
5.1.4 Remove the primary gowning in the Air lock-1, including sleepers.
5.1.5 Sanitize the hands with the disinfectant (70% IPA).
5.1.6 Enter in to the Air lock-2.
5.1.7 Wear sterile gloves.
5.1.8 Wear the sterile gowning including Headgear, Dangri and Booties.
5.1.9 Enter in to the Air lock-3.
5.1.10 Sanitize the hands with the disinfectant (70% IPA) once again and wear sterile gloves.
5.1.11 Check for proper gowning in the mirror. Ensure that no part of the body (except the slit for the eyes)

shall expose to the environment.
5.1.12 Enter in to the sterile area.
5.2 Exit
5.2.1 After completion of work, close LPG line. Transfer the media for incubation, glassware and

other material for washing through UV pass box ensuring that UV light is off.
5.2.2 Enter in the Return Room and close the door of sterility testing area.
5.2.3 Enter in Air lock-1 through Return Room and remove both the pair of hand gloves; Booties,

Dangri and headgear sequentially. Fold and put them into dust bin. Transfer this dust bin out

side the change room after completion of day work.
5.2.4 Wear personal (street) garments and primary gowning in Air lock-1 and exit from the Air lock-1 to corridor.
5.2.5 Records the entry and exit time and purpose in Annexure-1.
5.3 Personnel hygiene and General precautions
5.3.1 Staff in the Microbiology Department / who are authorized to enter in the Microbiology sterile area

should not have extra grown nails, beard and long hair.
5.3.2 Staff in the Microbiology Department / who are authorized to enter in the Microbiology sterile area

should free from cough, cold, skin allergy, wounds and other contagious diseases.
5.3.3 Staff in the Microbiology Department / who are authorized to enter in the Microbiology sterile

area should not have ornaments like ring, wrist watch, braslate etc.
5.3.4 Every personal entry into the microbiology testing sterile area should be authorized by the Microbiology

department head or his designee after verifying all aspects. Record the same in Annexure-1.
5.3.5 Ensure that both the doors of change room are not open at a time.
5.3.6 Use new sterile gown every time.
6.0 Forms and Records
6.1 Log of Entry and Exit in Microbiology sterile area – Annexure-1
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

Entry and Exit in Microbiology Sterile Area

Reason for Revision

Leave a Comment Cancel reply