Standard Operating Procedure (SOP)

Here is a detailed Standard Operating Procedure (SOP) for Entry and Exit into the Form Fill Seal (FFS) Area, commonly required in aseptic and controlled environments like pharmaceutical manufacturing:

1. Purpose

To define the procedure for controlled and contamination-free entry and exit of personnel in the Form Fill Seal (FFS) area to ensure product integrity and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel required to enter or exit the FFS area in the sterile manufacturing facility.

3. Responsibility

• Operators/Staff: Comply with entry/exit procedures strictly.

• Area Supervisor: Monitor adherence and ensure documentation.

• QA Personnel: Perform periodic checks and audits.

4. Materials and Accessories Required

• Clean room garments (gown, hood, mask, gloves, shoe covers, goggles)

• Hand sanitizer/disinfectant

• Mirror for gowning check

• Air shower (if applicable)

• Sterile gloves (for aseptic processing area)

5. Procedure

5.1 Entry Procedure

1. Initial Preparation:

   • Ensure you are not suffering from any contagious illness.

   • Remove personal items (jewelry, watch, phone, etc.).

   • Wear basic uniform and footwear provided in the change room.

2. Primary Change Room:

   • Remove footwear and change into clean area shoes.

   • Wear clean room garments (overall/scrubs, hair cover, mask, goggles, and shoe covers).

   • Sanitize hands with an approved hand disinfectant.

3. Secondary Gowning Area (Air Lock or Entry Vestibule):

   • Wear sterile gown (if required), sterile gloves, and over-shoes (boot covers).

   • Ensure proper gowning using the mirror (no skin exposure).

   • Step into the air shower (if available) and undergo the full cycle.

4. Entry into FFS Area:

   • Enter by pushing the door with the elbow or shoulder (avoid hand contact).

   • Maintain hygiene and avoid touching unnecessary surfaces.

5.2 Behavior Inside FFS Area

• Maintain silence and avoid unnecessary movement.

• Follow unidirectional flow and aseptic techniques.

• Report any garment damage or contamination immediately.

• Do not sit on the floor or lean against the walls.

5.3 Exit Procedure

1. Exit to Secondary Change Room:

   • Remove outer gloves and over-shoes inside the FFS area.

   • Sanitize gloves if re-entering multiple times during the shift.

   • Exit to the gown removal area and discard gown appropriately in the bin.

2. Primary Change Room:

   • Remove clean room garments and place in designated bins.

   • Change back into general factory attire.

3. Final Exit:

   • Exit the change room and sanitize hands.

   • Document exit time if required by facility protocol.

6. Precautions

• Do not enter the FFS area if suffering from cold, flu, or open wounds.

• Follow the sequence strictly to prevent contamination.

• Dispose of damaged garments/gloves immediately.

• Report any deviation to the supervisor or QA.

7. Documentation

• Entry/Exit Logbook

• Deviation Report (if applicable)

• Gowning Checklist (optional)

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