Standard Operating Procedure (SOP)

Here’s a clear and structured Standard Operating Procedure (SOP) for Garment Change and Entry/Exit through the First and Primary Change Room, typically used in controlled environments like cleanrooms in pharmaceutical, biotech, or electronics industries.

1. Purpose:

To ensure personnel follow a standardized procedure for gowning and de-gowning to minimize contamination risk when entering and exiting controlled or classified cleanroom areas.

2. Scope:

Applicable to all personnel entering or exiting the cleanroom via the First (Unclassified) and Primary (Grade D/C/B) Change Rooms.

3. Responsibilities:

• All personnel: Follow gowning procedures as per training and SOP.

• QA/Production Supervisor: Ensure compliance and perform periodic checks.

• Housekeeping/Cleanroom Maintenance: Maintain cleanliness and supplies.

4. Definitions:

• First Change Room: Area where personal items are removed and preliminary gowning is done.

• Primary Change Room: Area where cleanroom garments are worn prior to entry into classified zones (Grade D, C, B, or A).

• Garments: Gown, hood, face mask, gloves, booties/shoe covers, and goggles.

5. Safety and Hygiene Precautions:

• Do not enter change room with makeup, jewelry, or personal items.

• Fingernails must be short and clean.

• Report any illness or skin conditions to supervisor before entry.

6. Procedure:

6.1 Entry Procedure

A. In the First Change Room:

1. Enter the change room through the designated entrance door.

2. Remove outdoor shoes and place in designated rack or locker.

3. Remove personal belongings (e.g., watches, mobile phones, jewelry).

4. Wear designated cleanroom footwear or shoe covers.

5. Perform hand sanitization using provided sanitizer or wash station.

6. Wear:

   • Hair net/cap (ensure full coverage of hair and ears)

   • Face mask (covering nose and mouth)

   • Beard cover (if applicable)

✅ Proceed to the Primary Change Room

B. In the Primary Change Room:

1. Step over the bench (or barrier) as per zoning policy.

2. Wear sterile cleanroom garments in the following order:

   • Cleanroom gown/coverall

   • Hood (if separate from gown)

   • Goggles (ensure clear visibility)

   • Sterile gloves (ensure proper donning technique; cover gown cuffs)

   • Booties or over-shoes (last item before entering cleanroom)

3. Inspect yourself in the mirror for proper gowning.

4. Ensure garments are not touching the floor or walls.

✅ Enter the cleanroom through the designated door.

6.2 Exit Procedure

A. From Cleanroom to Primary Change Room:

1. Step into the primary change room without touching outer surfaces.

2. Remove gloves and dispose of them in the biohazard bin.

3. Remove goggles, hood, and gown in that order (avoid shaking).

4. Discard or place reusable items in designated area (laundry bin or storage).

5. Remove booties and step over the bench.

B. From Primary to First Change Room:

1. Remove face mask and hair net.

2. Dispose of all single-use items properly.

3. Change back into personal clothes/shoes.

4. Perform hand hygiene before leaving.

7. Frequency:

• Procedure must be followed each time personnel enter or exit the cleanroom.

• Garments must be changed daily or as per cleanroom class requirements.

8. Documentation:

• Gowning logbooks (if applicable)

• Deviation reports for non-compliance

• Training records for personnel

9. References:

• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products

• ISO 14644 – Cleanroom Standards

• Company Cleanroom Procedures Manual

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