In pharmaceutical manufacturing, following entry and exit procedures for staff and visitors is essential to prevent external environmental dust and microorganisms from entering the cleaned area. These procedures also help prevent contamination and cross-contamination within the manufacturing facility. According to WHO pharmaceutical guidelines, a well-defined procedure for on-premises entry and exit must be in place. Before entering or exiting the premises, follow the steps outlined below.
Entry and Exit Procedure for Production Staff:
Entry into the primary change room:
- Wash your hands with soap and water in the provided sink.
- Dry your hands with a dryer.
- Remove your street shoes.
- Place your shoes on the provided shoe rack and wear a shoe cover if applicable.
- Remove your street clothes and personal belongings, such as a wristwatch, wallet, jewelry, bindi, etc., and store them in individual lockers.
- Cross over the swing onto the bench.
- Take the clean factory garments – shirt and trousers for males, salwar, kameez, jacket, and scarf for females.
- Start by wearing the cap to completely cover your hair.
- Put on the factory garments and factory-provided shoes.
- Check your attire in the mirror to ensure proper gowning.
- Disinfect hands with 70 % IPA solution before entering the secondary change room.
- Male and female staff meant to work in the packing area need not enter the secondary change room (if applicable) and should directly go to the packing hall.
Entry into the manufacturing area:
- Enter the secondary changing room, then proceed to cross the swing over the bench.
- Put on a boiler suit and snood/hood.
- Next, wear the booties over the shoes.
- Before entering the processing area, disinfect the hands with 70% IPA.
Related Topics: Training of Personnel
Exit from Secondary Change room:
- Remove the booties, boiler suit, and shoes.
- Keep them in a designated place.
- Cross over the swing over the bench and exit the secondary changing room.
Exit from Primary change room :
- Remove the footwear and primary gown.
- Cross over the swing over the bench.
- Wear Street clothes and street shoes.
- Discard the cap/gloves in the waste bin after use.
Related: Entry-exit procedure in a Production area
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