Gowning and D-gowning Procedure for workers, staff and visitors in production Department
1.0 OBJECTIVE
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).
2.0 SCOPE
2.1 This standard operating procedure is applicable for the entry in capsule manufacturing area of Cephalosporin block at pharma dekho.
3.0 RESPONSIBILITY
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.
4.0 DEFINITION (S)
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).
5.0 PROCEDURE
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.
6.0 REFERENCES
Not applicable
7.0 ABBREVATION (S)
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 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
Preparation Filtration Usage and Destruction of Disinfectant Solution