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 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 microbiological testing of water
sop for depyrogenation of apparatus
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
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