ENTRY INTO ASEPTIC AREA [PICTORIAL]

1. Pre-entry checks (outside change room)

Before even touching the change room door:

• Health status
  • No fever, cold, cough, skin lesions, open wounds, eye infection, or GI upset.
  • Report any health issues to supervisor; do not enter if unfit.
• Personal items
  • Remove jewellery, watches, cosmetics (heavy makeup, nail polish), unsecured hair accessories.
  • No mobile phones, pens, or personal items beyond designated area.
• Clothing
  • Wear company-approved street clothes (no loose fibers, no wool).
  • Safety shoes as per site requirement up to the primary change room.

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2. Change Room – Stage 1 (Black to Grey)

Purpose: Remove gross contamination from outside environment.

• Step sequence (unidirectional flow):
  1. Enter black side (dirty side).
  2. Remove outdoor shoes and place in designated lockers/rack.
  3. Wear plant shoes / dedicated slippers.
  4. Don primary garments (if used at your site):
     • Hair cover / bouffant cap
     • Beard cover (if applicable)
     • Basic overcoat / factory coat
• Key rules:
  • Sit on change room bench: one side for dirty, other for clean.
  • Never let “dirty side” shoes cross to “clean side”.

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3. Handwashing & Hand Disinfection

Performed before putting on sterile gloves.

1. Remove visible dirt under nails (no long nails).
2. Turn on water (hands-free tap if available).
3. Wet hands and forearms up to the elbow.
4. Use approved non-perfumed antiseptic soap.
5. Wash for at least 30–60 seconds:
   • Palm to palm
   • Back of hands
   • Between fingers
   • Fingertips & nails
   • Thumbs
   • Wrists / forearms
6. Rinse thoroughly – no soap residue.
7. Dry with lint-free single-use towels.
8. Apply alcohol-based hand rub (ABHR) and allow to air dry completely.

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4. Change Room – Stage 2 (Grey to White)

This is where you wear sterile cleanroom garments.

Typical sequence (never touch the outside of sterile garments with unclean hands):

1. Don hood / head cover
   • Ensure all hair and ears are fully covered.
2. Face mask
   • Cover nose, mouth, and chin; mold nose strip; no gaps.
3. Shoe covers / boots
   • Wear over plant shoes or use dedicated sterile boots.
   • Tuck trouser legs inside if required by SOP.
4. Inner sterile gloves (if double-gloving)
   • Open sterile pack correctly.
   • Touch only inner surface while donning.
5. Sterile coverall / suit
   • Handle from inner surface only.
   • Avoid touching the floor.
   • Zip fully; ensure cuffs and ankles are properly closed.
6. Goggles / eye protection
   • Use sterilized goggles (packed or autoclaved).
   • Ensure no fogging; if fogging, adjust before entry.
7. Outer sterile gloves
   • Disinfect inner gloves with ABHR, let dry.
   • Open outer glove pack aseptically.
   • Don without touching outer surface with bare skin.
8. Final check in mirror
   • No exposed hair, no gaps in mask, zipper closed, boots secure.

Golden rule: Once gowned, do not touch face, mask, hood, or non-sterile surfaces. If you do, disinfect or change gloves/garments as per SOP.

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5. Airlock Entry to Aseptic Area

• Verify differential pressure is within limit before opening door.
• Use interlocked doors properly:
  • Only one door open at a time.
  • Wait for laminar airflow / air shower cycle if installed.
• Step on disinfectant mat or tacky mat as per procedure.
• Disinfect gloved hands with sterile IPA (70%) at entry.
• Enter calmly – no rushing, no unnecessary movement.

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6. Behaviour Inside Aseptic Area

Once inside:

• Movement & posture
  • Move slowly and deliberately; no sudden arm movements.
  • Avoid walking close to walls, filters, or over open sterile items.
• Touch discipline
  • Touch only what is required for the job.
  • Never touch floor, walls, or non-classified items.
  • Frequently disinfect gloves with sterile IPA as per SOP.
• Talking & communication
  • Minimize talking, especially over exposed materials.
  • No shouting, laughing, or unnecessary conversation.
• Personal habits
  • No scratching, rubbing eyes/nose, adjusting mask, or crossing arms inside gown.
  • If mask becomes loose, wet, or damaged → exit to change room and regown.

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7. Re-entry & Re-use Rules

• Short exit (e.g., to unclassified corridor)
  • Follow site SOP: often requires at least regloving and redisinfection, sometimes partial regowning.
• Long break / washroom use / major gown disturbance
  • Complete re-gowning from Stage 1 is usually required.
• Damaged/soiled garment or glove
  • Leave area via proper exit route.
  • Replace garment/gloves with fresh sterile ones.
  • Perform full hand disinfection steps again.

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8. Common Non-compliances (to use as “Don’t” list on a poster)

• Entering with:
  • Illness or visible skin issues
  • Cosmetics, perfume, jewellery
• Stepping from dirty side directly to clean side.
• Wearing mask below nose or exposing hair/beard.
• Walking too fast, waving arms, leaning over open products.
• Touching doors, walls, or floor and then touching sterile items.
• Reusing torn / dropped gloves or garments.
• Talking over open vials/containers.