SOP for Gowning for Entry into Biomanufacturing Suite

Purpose

To describe the proper gowning procedure for personnel entering the biomanufacturing suite to minimize the number of particles and viable microorganisms in the suite.

Scope

This applies to gowning performed in the gowning area before entering the biomanufacturing suite.

Responsibilities

• It is the responsibility of the course instructor/lab assistant to ensure that this SOP is performed as described and to update the procedure when necessary.
• It is the responsibility of the students/technicians to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

Precautions

70% isopropyl alcohol is flammable and poisonous if ingested. Avoid creating excessive mist when using spray bottles with IPA.

Materials

• Disinfecting hand soap
• Sterile 70% (v/v) isopropyl alcohol (IPA)
• Headcover
• Hood (if needed)
• Facial hair cover (if needed)
• Cleanroom coverall, sterile Tyvek
• Shoe covers
• Non-powdered nitrile gloves
• Sterile gloves
• Lab tissues such as Kimwipes
• Boots
• Hood

Procedure

• Employees should wear clean clothes that are not overly capable of shedding particulates (i.e., wool sweaters).
• Gowning must occur only when no one is entering or exiting the gowning area. Likewise, do not enter the gowning area while someone is gowning.
• Wearing makeup and jewelry is prohibited in the cleanrooms. If necessary, remove makeup and jewelry before proceeding to the Pre-Gowning Area.

Pre-Gowning Area

• Enter the pre-gowning area.
• Wash hands
• Put on nitrile gloves. Choose gloves that have a snug but not overly tight fit.
• Sanitize safety glasses with 70% (v/v) IPA, dry them with a lab tissue, and place them on the face.
• Don's head cover. Use the mirror to verify that all hair is completely covered up to and including the hairline.
• If applicable, don a beard cover and place it over facial hair. Use the mirror to verify that all hair is completely covered.

1. If facial hair is still exposed, replace the head cover with a hood. Verify That all hair is completely covered.

• Put on shoe covers
• Proceed to the gowning area.

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Gowning Area

Note: Avoid creating excess mist while using IPA throughout this procedure.

• Sanitize gowning bench with sterile 70% (v/v) IPA.
• Sanitize gloves with sterile 70% (v/v) IPA.
• Donning the hood and coverall

1. Place hood on head taking care to touch only the inside
2. Obtain a gowning package.

• Inspect the integrity of the package and verify that the package has been autoclaved.
• Open the package, Remove the coverall from the package, and place it on the bench Note: Avoid touching the coverall to the floor at all times.
• Inspect the boots for rips or tears, place them on the bench
• Sanitize gloves with sterile 70% (v/v) IPA.
• Unzip the coverall.
• Gather the arms and one leg of the coverall together.
• Place leg in coverall and pull up the coverall. Repeat the process with the other leg. Do not allow the coverall to touch the floor.
• Pull the coverall up over the body and zip make sure the base of the hood is covered
• Sit on a bench and put on a single boot.
• Swing a leg over the bench to clean the side of the gowning area. Apply other boots and stand on the clean side of the gowning area.
• Put on sterile gloves
• Sanitize gloves with sterile 70% (v/v) IPA.

• After gowning, employees may enter the biomanufacturing area. While performing aseptic processing, resanitize gloves as needed. Reglove or regown if any adverse circumstances are observed or suspected that may affect the integrity of the gown components.
• Regown by exiting the biomanufacturing suite and repeating this SOP.

Exiting the biomanufacturing suite

• Proceed to the exit area.
• Discard coveralls and other cleanroom garbs appropriately in the receptacle.
• Regown with fresh supplies when reentering the area.
• Gowning qualifications for non-qualified personnel.

1. Non-qualified personnel (employees, outside contractors, or visitors) may not enter the biomanufacturing suite without permission from the Director of Manufacturing or QA/QC.
2. Upon permission, non-qualified personnel must gown with instructions and in the presence of a fully qualified operator and be monitored using applicable standard procedures.
3. All occurrences of non-qualified personnel entering the biomanufacturing suite between the time of room sanitization and completion of a batch must be documented using a discrepancy report.

Annexure

Nil

Revision History

Nil

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