1.0
Purpose
1.1 To establish a formal procedure
for the gowning & de-gowning procedure at sterile area.
2.0
Scope
2.1 This procedure is applicable for gowning
and de-gowning for sterility test in the Microbiology Laboratory.
3.0
Responsibilities
3.1
Microbiologists
and room cleaner are responsible to follow the SOP.
3.2
Head
of Quality Control/In-Charge is responsible for the
implementation of this SOP.
3.3
Head
of Quality Assurance is responsible for SOP compliance.
4.0 Abbreviations and Definitions
4.1 Clean
room-
A clean room is an environment, typically used in
manufacturing or scientific research that has a low level of environmental
pollutants such as dust, airborne microbes, aerosol particles and chemical
vapors.
4.2 Change
room-
A change room is a room or area designated for changing
one's cloth.
4.3 Sterile-
Free from live bacteria or other micro-organisms.
4.4 Disinfection-
The destruction of pathogenic and other kinds of
micro-organisms by physical or chemical means.
5.0 Materials and Equipment
5.1
Not Appreciable
6.0
Precaution
/ Health and Safety Considerations
6.1
Personnel
suffering from or recovering from the following are required to notify
supervision.
·
Viral
skin conditions, e.g., warts and verruca(s) herpes simplex (cold sores),
shingles and chicken pox.
·
Septic skin lesions.
·
Conjunctivitis.
·
Discharging
ear.
·
Sore
throat.
·
Dental
or gum sepsis.
·
Common
cold or influenza.
·
Chest
infection.
·
Diarrheas'
and/or vomiting.
·
Hepatitis.
·
Athlete’s
foot.
·
Any
other infectious disorders.
6.2
Hair
coverings and beard covers (for both beards and moustaches) or mask must be
worn in designated areas
6.3
Avoid
unnecessary movements.
6.4
Do
not sit on the floor. If this happens it is required to change the dress and
wear new clean dress.
6.5
All
gowns used for class “B” area must be washed after single use in the dedicated
washing machine.
7.0
Procedure
7.1 Gowning Procedures
7.1.1
Disinfect
hands by disinfectant solution placed beside the entry door.
7.1.2
Enter
change room by opening the door. The door must be opened for the minimum
possible time.
7.1.3
Remove
apron and head cover and keep it in the dress cabinet properly.
7.1.4
Remove
shoes and place it at the designated place.
7.1.5
Disinfect
hands with 70% Isopropyl Alcohol.
7.1.6
Collect
an autoclaved coverall from the sterile dress box.
7.1.7
Wear
the coverall ensuring it does not come
into contact with the floor. Notice whether it is coming into contact
with floor or not.
7.1.8
After
wearing the coverall fasten the cap attached with the coverall.
7.1.9
Collect a pair of suitably sized sterile
gloves from the sterile dress box.
7.1.10
Disinfect
gloved hands with 70% IPA ensuring that cuffs of the coverall are well covered.
7.1.11
Ensure
gloves are not damaged in the process.
7.1.12
Open
the door to enter into the sterility test room.
7.1.13
Enter
sterility test room from Change room. The door must be opened for the minimum
possible time.
7.2
De-Gowning Procedures
7.2.1
Spray
hands with 70% IPA.
7.2.2
Take
off the coverall and put them in wastage basket.
7.2.3
Take
out shoes, apron and head cover from the dress cabinet and wear to ensure that
no hair portion is outside the cap area.
7.2.4
Come
out from the change room opening the door.
8.0
Reference
Document
8.1 WHO
Guidelines, volume 2, second edition.
9.0 Annexure
9.1 Not
Appreciable
10.0 Revision History
|
Revision No. |
Brief reason for the
revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0 Training
11.1 Head
of Quality Control or his/her nominee shall give the SOP training before
effective date.
