gowning procedure for microbiological testing area

gowning procedure for microbiological testing area

1.0 OBJECTIVE 
1.1 The objective of this SOP is to define the procedure for gowning as well as degowning of any sterile gown employed for aseptic areas.

2.0 SCOPE
2.1 This SOP is applicable for for gowning as well as degowning of any sterile gown employed for aseptic areas
3.0 RESPONSIBILITY
3.1 Microbiologist-Quality control- To follow the SOP for gowning as well as degowning of any sterile gown employed for aseptic areas.
3.2 Head- Quality Control – Training on SOP.
3.3 Head- Quality Control- Implementation & follow up of SOP.
4.0 ACCOUNTABILITY
4.1 Head – Quality Control
5.0 REFERENCE(S)
5.1 In-House

 

6.0 PROCEDURE
6.1 GOWNING
6.1.1 Remove all street clothing, factory uniforms and hang properly inside the SS dress cabinet on SS dress hanger kept in the IST Change room.

Also remove all ornaments, wrist watches and keep them properly inside the SS dress cabinet.
6.1.2 Disinfect both the hands up to elbow with the 70% IPA solution kept in the IST Change Room. Remove dirt from both the feet

by stepping over the tacky mat placed before entering the IInd change room.
6.1.3 Enter the IInd Change room, by opening the door of the IInd Change room with the help of elbow.
6.1.4 First wear a pair of sterilized gloves in both hands. Now take out sterile gown wrapped in butter paper/parchment Paper from garment cabinet.
6.1.5 Wear sterile facemask and then wear the headgear. Tie the headgear properly such that all hairs should be tucked inside the headgear.
6.1.6 Next, wear the boiler suit carefully by holding the boiler suit by two ends and crimp it. Now slowly slip one of the legs inside the suit in such a

way that the suit should not touch the floor or wall of the room. Then slip the other leg similarly by taking care.
6.1.7 Next, slip both hands properly inside the boiler suit carefully by stretching both the hands. Tuck the Headgear properly inside the boiler suit.
6.1.8 Sit on the SS Crossover bench and wear the booties properly for one leg. Move the leg to other side of the cross over bench and then follow

the same procedure for the other leg. Tuck the leg portion of boiler suit inside the booties properly.
6.1.9 Cross the SS Crossover bench and move to other side of the room in a sitting position. Wear cleaned eyeglass properly.
6.1.10 Now wear second pair of sterilized hand gloves over the existing hand gloves pair and then tuck the cuff of boiler suit properly inside the hand gloves for both the hands.
6.1.11 Rinse both the hand gloves with 70% filtered IPA solution kept at IInd Change room .
6.1.12 Checking of final gowning procedure shall be done in front of the mirror attached in the IInd Change room. Move inside the clean corridor by opening the with the help of elbow.

 

6.2 DEGOWNING
6.2.1 After completing the work inside the sterile analysis area, move into the clean corridor by opening the door. Pull open the doors of the Exit Air Lock 1st.
6.2.2 Remove carefully and slowly the booties, boiler suit and the head gear in the and dispose the dress properly inside Closed SS container for washing.
6.2.3 Dispose the used hand gloves as well as facemask in a separate SS closed disposal bin.
6.2.4 Wear the factory uniform, wristwatch and ornaments by taking it out from the SS dress Cabinet properly and slowly exit from the IST Change room.
6.2.5 Keep the eyeglasses inside the SS dress cabinet and reuse the eyeglasses after moping and drying properly with filtered disinfectant solution, immediately before gowning operations.

7.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QAD : Quality Assurance Department
QCD : Quality Control Department
IPA : Isoproply alcohol
NA : Not Applicable
No. : Number

 

 

 

 

sop for calibration and validation of micro autoclave

sop for Sterility failure investigation

cleaning and operation of discard autoclave

sop for operation of fogger machine

sop for Biological assay of lactic acid bacillus

sop for preparation of culture inoculum

STP for sterility testing of sterile gloves

sop for Operation and calibration of active air sampler

sop for transfer of material for testing and sampling in sterile area

entry & exit procedure in microbiology laboratory

Growth Promotion Test In Microbiology Laboratory

Operation of B.O.D in Microbiology Laboratory

Operation of Horizontal Laminar Air Flow in the microbiology laboratory

Operation and cleaning of Pass Box.

Operation and cleaning of air sampler

Cleaning and Sterilization of Glassware

Analysis of water for microbial load in microbiology lab

Operation and temperature monitoring of Refrigerator

Fumigation of Microbiology Laboratory.

Entry & Exit procedure In Sterility Area

SOP for Microbial analysis of Raw Material Finished Products

SOP for Operation & Calibration of pH meter in Micro Department

SOP for Operation & Calibration of pH meter in Micro Department

SOP Operation and calibration of Hot Air Oven In Microbiology

SOP for operation cleaning & calibration of Digital colony counter

SOP for Operation And Cleaning of Microscope

sop for Media Preparation and Consumption

sop for Receipt Storage and Usage of Culture Media

sop for Cleaning Sanitization And Disinfection In Microbiology

sop for Environmental monitoring of all the Classified area

sop for Handling and Sub culturing of Microbial cultures

sop for Media Growth Promotion Test and various Microbiological test

sop for BOD incubator operation and cleaning

sop sampling of water for microbiological analysis

sop for Disinfectant Efficacy Test

sop for for cleaning and operation of vortex mixture

sop for Temperature & Relative Humidity Monitoring

sop for Operation and Calibration of Heating Block

sop for Sterility Testing of Microbiology

sop for Disposal of Culture Media

sop for Drain point of Microbiology

sop for entry & exit procedure In Microbial limit test and Biosafety

sop for Gram Staining of Bacteria in Microbiology Laboratory

sop for Monitoring of Compressed Air/gases for microbiological analysis

sop for BET (Bacterial Endotoxin) test in Microbiology

sop for receipt storage and Determining the population of Biological indicators

sop for qualification of analyst microbiologist

sop for Bioburden test of Packing materials in Microbiology Laboratory

sop for microbiological assay of erythromycin antibiotic

sop for liquid particle counter

sop for operation and calibration of digital zone reader

sop for monitoring of ultraviolet efficiency LAF and pass box

microbiological assay of cyanocobalamin or vitamin B12

gowning procedure for microbiological testing area

swab testing of various surfaces for bioburden determination

sop for endotoxin challenge test

Hold time study protocol for sterilized media

sop for personnel Qualification protocol for aseptic area

sop for sampling and testing of drain water

Sop for Operation of Airborne Particle Counter

sop for Inoculum Preparation

sop for Validation protocol of steam sterilizer autoclave

sop for pathogen detection from drain point

Sop for Analysis of Raw water Purified water water for injection and pure steam water

sop for preservatives efficacy test

sop for collection and preservation of in house isolated microorganisms

sop for Operation Calibration and Maintenance of Micropipette

Sop for UV Efficacy Test

sop for gram staining

Sop for swab testing

sop for microbiological testing of water

PROCEDURE FOR FUMIGATION

sop for depyrogenation of apparatus

sop for media preparation

sop for fertility test growth promotion test of media

sop for Operation and cleaning of moist heat sterilizer

sop for monitoring by active air sampler

sop for swab sampling and testing for clean rooms in production area

sop for monitoring in microbiology laboratory

sop for Fumigation of aseptic area and microbiology lab

sop for monitoring of personnel in aseptic area

sop for maintenance of cultures

sop for Operation and cleaning of laminar bench

preparation of settle plates

sop for monitoring of pure steam

sop for entry and exit procedure to m.l.t and b.e.t room

sop for storage of and use of media

sop for disposal of microbiological media and cleaning of microbiological glassware

 

 

 

 

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