Process For Gowning – Entry And Exit Change Rooms

It is important for a pharmaceutical company to have procedures in place to prevent contamination within the building and especially in the processing area. The procedure needs to cover the changing of clothes during entry and exit of the designated changing areas. The following assumes there is a first change room that all visitors to the site or factory will have to pass through. This provides protection for staff entering the warehouse, dispensing and sampling areas. A further change room (the Primary Change Room) is necessary to prevent contamination of the more critical areas of the facility, i.e., the manufacturing and packaging sections.

Colour Coding of Uniform

Colour-coding of uniform can be used to identify personnel and their department. A suggested colour-coding scheme for the first change room and primary change room is as indicated below:

• Brown – Engineering department
• Moss green/Disposable – Visitors, Guests
• Steel Grey – Warehouse personnel
• White – QA personnel, Office Staff, Production. Quality Control
• Sky Blue lint-free - Manufacturing/Sampling/Dispensing – (Primary change room )
• Brown lint-free – for employees in primary area of the Engineering department

Photos of the garments should be displayed in the changing rooms.

First Change Rooms – Male and Female staff and visitors to the facility

• Cleaned and washed factory garments should be provided every Monday and Thursday to employees as required.
• Cleaned, and washed factory socks should provided every day.
• Jewellery, street clothes and shoes should be placed in the staff’s locker room.
• Appropriate black coloured shoes and socks should be provided and worn by staff working in the facility.
• Disposable garments should be provided for guests or visitors.
• Shoe covers should be provided for visitors.

Primary Change Room – for male and female personnel (e.g., working in the sampling and dispensing room in the warehouse)

• Cleaned, and washed primary change uniforms should be provided every Monday and Thursday, or other days if needed.
• A change of uniform is required for every product changeover.

Procedure on gowning for staff working manufacturing and primary packaging personnel

• After entering the primary change room, staff should remove their street shoes and place them in the rack provided
• Apply disinfectant to both hands.
• Move over to the changing bench.
• Take lint free trousers, caps and shirt from the hanger.
• Put on lint free shirt, trouser and caps over the previously donned uniform.
• Wear brown coloured shoes that are provided in the locker.
• Note - shoe covers or brown shoes should be provided for visitors.
• Apply disinfectant to both hands.
• After the primary change, personnel should go to their respective departments.
• Wear nose/face mask when entering the primary packaging or manufacturing area.

Procedure on leaving the primary change area (for sampling and dispensing personnel warehouse)

• Remove the primary shoes and return them to the locker.
• Remove the link free garments, and cap and place these back to the locker.
• Cross over to the changing bench.
• Wear first change (black) shoes.

Procedure on exiting the first change room out of the facility.

• Place shoes and uniform in the assigned locker
• Drop used socks to the bin in the first change room after work.
• Dispose of any disposable garment in the waste bin.
• Collect all personal belongings and put on street clothes.

Note: Remove the first change shoes and wear separate footwear when entering the toilet. Remove the toilet footwear and wear the first change shoes after leaving the toilet area.