GOWNING
Md. Shariful Islam
Executive, QA
Genvio Pharma Ltd
What is Gowning?
The process of wearing special garments in order to prepare
oneself to enter into an environment-controlled area to
avoid any possible particulate contamination.
Purpose of Gowning
➻To protect ourselves form harmful effect by chemicals.
➻To protect products or samples from contamination by ourselves.
Gowning can cover some or all of the following
➻ Head / hair
➻ Beard / mustache
➻ Face
➻ Torso / Upper body
➻ Legs / pants
➻ Feet / shoes
➻ Hands
At Home Preparation
➻Shower
➻Shave
➻Brush teeth
➻Brush hair
➻Proper attire
➻Skin moisturizers
➻Practice good personal hygiene
➻Select non shedding undergarment
➻Select non shedding over garments
Pre - Gowning work
➻ Report any medical condition to supervisor
➻ Store all outer garments and personal belongs to separate and secure
➻ Remove all non-approved jewelry and store
➻ Remove cosmetics
➻ Wash and dry hands
➻ Put on factory gowns accordingly
Some Restrictions
Personnel shall be restricted
from wearing….
➻Jewelry
➻ Wrist watch
➻Cosmetics/Lipsticks
➻Hair spray/perfumes and
➻ carrying mobile.
Some instructions
There are a few key things to look for when observing gowning practices:
1. Employees should be wearing clean, appropriate clothing. This means no
loose clothing that could potentially come into contact with the product.
2. Employees should be wearing the proper PPE for the job they are
performing. This includes gloves, hairnets, and eye protection if necessary.
3. The work area should be clean and free of debris. This helps prevent cross-
contamination and ensures that employees are working in a safe environment.
4. All equipment should be properly sanitized before use. This includes any
tools or machines that will come into contact with the product or ingredients.
5. There should be a clear process in place for handling waste materials.
Change Room
A room or area designated for changing one's clothes. Changing
rooms are provided in a semi-public or public situation.
Separate changing rooms may be provided for men and women
Gowning procedure
●
Wash hand & dry
●
Sit on the step over bench and remove outside shoe and keep in the locker
●
Crossed step over bench by swinging the legs over the bench.
●
Wear new shoe and and coverall gowning
●
Head cover, mask, goggles, gloves accordingly
●
Inspect yourself in the mirror.
Gowning Personnel Routes
➪Primary change room Analysis area.
➪Primary change room Secondary change room
Operation area (Manufacturing/API related
area)
➪Personnel routes are strictly maintained
Primary Change room
Primary change room area should be cover……
➻ Wear coverall apron
➻ head cover
➻ Mask
➻ Gloves
➻ show cover
➻ goggles
Without API
related work
Visitors
Secondary Change room
Primary gowning
Secondary Change room
●
Wear Secondary coverall
apron
●
Wear hood
●
Wear Respiratory hood with
air filter motor.
Secondary Gowning
De – gowning (Manufacturing area)
➻Take air shower if you are from manufacturing
area.
➻When leave the area always keep the secondary
gowns and re-usable materials(i.e. Respiratory
hood) in the specific bin or area.
➻Leave the disposable materials or one time used
materials (ie. mask, gloves) in waste bin.
➻Wash hand with 70% IPA
De – gowning (Analysis area)
➻When leave the area always keep the gowns and re-
usable materials in the specific bin or area.
➻Leave the disposable materials or one-time used
materials (i.e. mask, gloves) in the waste bin.
➻Leave your shoe and keep in the locker
➻Wash hand with 70% IPA
➻Cross step over bench by swinging
➻Wear outside shoe.
GOWNING.pdf
GOWNING.pdf

GOWNING.pdf

  • 1.
  • 2.
    What is Gowning? Theprocess of wearing special garments in order to prepare oneself to enter into an environment-controlled area to avoid any possible particulate contamination.
  • 3.
    Purpose of Gowning ➻Toprotect ourselves form harmful effect by chemicals. ➻To protect products or samples from contamination by ourselves.
  • 4.
    Gowning can coversome or all of the following ➻ Head / hair ➻ Beard / mustache ➻ Face ➻ Torso / Upper body ➻ Legs / pants ➻ Feet / shoes ➻ Hands
  • 5.
    At Home Preparation ➻Shower ➻Shave ➻Brushteeth ➻Brush hair ➻Proper attire ➻Skin moisturizers ➻Practice good personal hygiene ➻Select non shedding undergarment ➻Select non shedding over garments
  • 6.
    Pre - Gowningwork ➻ Report any medical condition to supervisor ➻ Store all outer garments and personal belongs to separate and secure ➻ Remove all non-approved jewelry and store ➻ Remove cosmetics ➻ Wash and dry hands ➻ Put on factory gowns accordingly
  • 7.
    Some Restrictions Personnel shallbe restricted from wearing…. ➻Jewelry ➻ Wrist watch ➻Cosmetics/Lipsticks ➻Hair spray/perfumes and ➻ carrying mobile.
  • 8.
    Some instructions There area few key things to look for when observing gowning practices: 1. Employees should be wearing clean, appropriate clothing. This means no loose clothing that could potentially come into contact with the product. 2. Employees should be wearing the proper PPE for the job they are performing. This includes gloves, hairnets, and eye protection if necessary. 3. The work area should be clean and free of debris. This helps prevent cross- contamination and ensures that employees are working in a safe environment. 4. All equipment should be properly sanitized before use. This includes any tools or machines that will come into contact with the product or ingredients. 5. There should be a clear process in place for handling waste materials.
  • 9.
    Change Room A roomor area designated for changing one's clothes. Changing rooms are provided in a semi-public or public situation. Separate changing rooms may be provided for men and women
  • 10.
    Gowning procedure ● Wash hand& dry ● Sit on the step over bench and remove outside shoe and keep in the locker ● Crossed step over bench by swinging the legs over the bench. ● Wear new shoe and and coverall gowning ● Head cover, mask, goggles, gloves accordingly ● Inspect yourself in the mirror.
  • 11.
    Gowning Personnel Routes ➪Primarychange room Analysis area. ➪Primary change room Secondary change room Operation area (Manufacturing/API related area) ➪Personnel routes are strictly maintained
  • 12.
    Primary Change room Primarychange room area should be cover…… ➻ Wear coverall apron ➻ head cover ➻ Mask ➻ Gloves ➻ show cover ➻ goggles
  • 13.
  • 14.
  • 15.
    Secondary Change room ● WearSecondary coverall apron ● Wear hood ● Wear Respiratory hood with air filter motor. Secondary Gowning
  • 16.
    De – gowning(Manufacturing area) ➻Take air shower if you are from manufacturing area. ➻When leave the area always keep the secondary gowns and re-usable materials(i.e. Respiratory hood) in the specific bin or area. ➻Leave the disposable materials or one time used materials (ie. mask, gloves) in waste bin. ➻Wash hand with 70% IPA
  • 17.
    De – gowning(Analysis area) ➻When leave the area always keep the gowns and re- usable materials in the specific bin or area. ➻Leave the disposable materials or one-time used materials (i.e. mask, gloves) in the waste bin. ➻Leave your shoe and keep in the locker ➻Wash hand with 70% IPA ➻Cross step over bench by swinging ➻Wear outside shoe.