ENTRY PROCEDURE IN MANUFACTURING CORRIDOR [PICTORIAL]

1.0 OBJECTIVE

To define the standard entry procedure for personnel into the manufacturing corridor of the oral solid dosage (OSD) area to prevent contamination, mix-ups and to maintain GMP.

2.0 SCOPE

This procedure is applicable to all personnel (Production, QA, Maintenance, Housekeeping, Visitors) entering the OSD manufacturing corridor and its associated rooms.

3.0 RESPONSIBILITY

• All Personnel – To follow this entry procedure strictly.
• Production / QA – To ensure compliance and perform routine checks.
• HR / Training – To ensure all concerned staff are trained on this SOP.

4.0 GENERAL REQUIREMENTS

4.1 Health & Hygiene

• Do not enter if you have:
  • Open wounds, oozing skin lesions, severe respiratory infection, or diarrhoea.
• Report sickness to supervisor / HR before entering.

4.2 Personal Items (Before Entry)

• No jewellery, watches, bangles, loose chains.
• No cosmetics, strong perfumes, hair oil that may shed/emit vapours.
• No eatables, water bottles, mobile phones, pens with loose caps, etc. inside manufacturing corridor (unless specifically allowed and controlled).

5.0 ENTRY FLOW – MANUFACTURING CORRIDOR (TYPICAL TWO-CHANGE SYSTEM)

Adjust “Room-1, Room-2” names as per your site layout.

5.1 Entry to Primary Change Room (Street to Plant)

1. Enter Change Room–1 (Primary) from external corridor.
2. Verify:
   • Status board / door label – “CHANGE ROOM – CLEAN / IN USE”.
   • Housekeeping and waste bins are clean and not overflowing.
3. Remove:
   • Street footwear, place in designated rack.
   • Personal jackets/outerwear, caps, etc.
4. Wear:
   • Plant slippers / shoes provided in the change room (clearly identified by colour/ID).
   • Hairnet / head cap to fully cover hair.
   • Beard cover (if applicable).

You are now in “plant attire” but not yet ready for manufacturing corridor.

5.2 Entry to Secondary Change Room (Plant to Manufacturing Corridor)

1. Enter Change Room–2 (Secondary / Airlock) from plant side.
2. Ensure differential pressure and temperature are within limits (display / BMS / magnehelic gauge):
   • Temp: NMT ___ °C (e.g. 27 °C)
   • RH: NMT ___ % (e.g. 55%)
   • DP as per layout (corridor > change room > external).
3. Remove plant slippers and wear corridor-designated footwear if system demands separate shoes (ex: blue = corridor, green = core area).
4. Perform hand hygiene:
   • Wash hands with liquid soap and potable water (if hand wash station present).
   • Dry hands with disposable tissue, not cloth towel.
   • Apply hand disinfectant (IPA-based / site approved).
5. Wear corridor gowning as per your site (typical OSD):
   • Clean inner protective clothing, such as:
     • Trouser & shirt / coverall
     • Over-gown / lab coat (if used)
   • Head cover & beard cover (if not already adequate).
   • Disposable mask or reusable mask as per SOP.
   • Powder-free gloves (if required at corridor level; mandatory for entry into rooms where product is exposed).
6. Check gown:
   • No open buttons/zip.
   • Gown not torn, stained or excessively creased.
7. Step on foot bath / sticky mat / shoe sole cleaner (as applicable) at exit of change room.
8. Enter the manufacturing corridor only through the designated personnel door.
   • Do not hold doors open with wedges or bins.
   • Ensure door is properly closed behind you (airlock principle).

6.0 RULES INSIDE MANUFACTURING CORRIDOR

Once inside the corridor:

6.1 Movement & Behaviour

• Walk calmly, do not run or push trolleys aggressively.
• Avoid leaning on walls, doors, equipment windows.
• Do not sit on the floor, pallets, or steps in the corridor.

6.2 Material & Document Handling

• Use designated material doors / pass boxes for materials – never carry materials through personnel airlocks if SOP prohibits.
• Carry BMR / documents in clean document folders; do not place directly on floor.

6.3 Gown Integrity

• Keep gown fully closed at all times.
• If gown gets visibly dirty, torn, or wet, exit via proper route and replace gown before re-entry.

6.4 Food / Drink / Smoking

• No food, chewing gum, tobacco, pan, etc.
• Smoking strictly prohibited anywhere inside production block.

7.0 TEMPORARY EXIT & RE-ENTRY DURING SHIFT

(Example: washroom break, cafeteria, meeting)

7.1 Exit Procedure

• Exit manufacturing corridor via reverse gowning sequence defined in plant SOP (usually back through secondary change, then primary).
• Remove outer gown and corridor footwear in the correct order and store in designated racks/lockers if re-use is allowed for the same shift; else send for washing/disposal.

7.2 Re-Entry

• Re-enter following full entry procedure again:
  • Primary change → Secondary change (hand wash, mask, cap, gown, footwear) → Corridor.
• Do not short-cut steps because it’s a “quick” entry.

Rule of thumb: Each time you cross from non-manufacturing side to manufacturing corridor, perform the full entry sequence.

8.0 EXIT AT END OF SHIFT

1. Exit manufacturing corridor through designated personnel exit.
2. Remove gloves and discard in bio / general waste as per segregation SOP.
3. Remove gown in change room, turn inside out (if reusable), and place in soiled linen bin.
4. Remove mask, cap, beard cover and discard as per waste SOP.
5. Remove corridor footwear and place on rack; change to plant / personal footwear in primary change room.
6. Wash hands before leaving the block.

9.0 QUICK ENTRY CHECKLIST – MANUFACTURING CORRIDOR

You can convert this into a checklist format in your BMR or log book:

S. No.	Check Point	Yes / No / NA	Checked By / Date
1.	Street footwear removed and plant footwear worn
2.	No jewellery, watch, loose items
3.	Head cover / beard cover properly worn
4.	Hands washed / sanitized before entry
5.	Mask properly worn, nose and mouth covered
6.	Corridor gown intact, fully closed (no open buttons/zip)
7.	Correct corridor footwear and sticky mat/foot bath used
8.	Room DP, temp, RH within limit (if displayed at entry)
9.	Door properly closed after entry