Gowning and D-gowning Procedure for workers staff and visitors in production Department



Gowning and D-gowning Procedure for workers, staff and visitors in production Department

1.1 To lay down a procedure to be followed for Entry & Exit of Executives, Staff, and Visitors in production area (gowning and degowning procedure).

2.1 This standard operating procedure is applicable for the entry in capsule manufacturing area of Cephalosporin block at pharma dekho.

3.1 Individual executive / staff / visitors entering in the production area.
3.2 Head, production shall be responsible for implementation and compliance of this procedure.

4.1 Process Area (core area.): Area directly comes in contact with product (Granulations, compressions , capsule processing and filling area, coating, blister packings , Liquid manufacturing and filling area , Bulk packing ,strip packing area and dispensing area of store.
4.2 Primary Packing: Area that does not come in contact with product directly (corridor and packing Hall).

5.1 Enter in the staff change room. Remove your shoes and keep in the shoe rack provided separately.
5.2 Sit on the swing over bench lift both feet together and cross over to the other side.
5.3 Wash hands with liquid soap in wash basin.
5.4 Unlock the locker, wear your production uniform (i.e. coat, cap and slipper) kept in the locker provided.
5.5 Enter in the corridor through the other door of the change room and reach the concerned area. Person with this primary change can access to all the areas not handling directly the core product.
5.6 For ENTRY in the core area (Process area) person shall enter in the secondary gowning room. secondary gowning rooms for entering tablet granulation, compression, coating, liquid manufacturing, filling and sealing, ointment manufacturing, and filling, capsule manufacturing and filling are provided seperately. In secondary gowning cross the swing over bench, wash hand and dry. Wear dangri / hand gloves and mask before entering the core area.
5.7 For exit from core area person shall remove their secondary gowning uniform (i.e. dangri, hand gloves and mouth piece) in process change room and shall be kept in the designated lockers.
5.8 Cross the swing over bench for toward exit door of secondary change room.
5.9 For exit from production area come back to the primary change room. Person shall remove production uniform (coat, cap, slipper,) and shall be kept in the designated lockers. Cross the swing over bench. Wear personnel shoes and exit the from the exit door.
5.10 Person shall change his secondary gowning with every product change over or at time of these are looking dirty.
5.11 Person shall change his primary gowning whenever these looking dirty.

Not applicable

Not applicable


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


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

Preparation Filtration Usage and Destruction of Disinfectant Solution


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