Standard Operating Procedure (SOP)

Here is a complete Standard Operating Procedure (SOP) for the Sanitization of FFS (Form-Fill-Seal) Area, ensuring compliance with GMP standards and maintaining environmental control in sterile and non-sterile manufacturing areas.

1.0 Objective

To establish a procedure for the proper and consistent sanitization of the Form-Fill-Seal (FFS) area to minimize microbial contamination and ensure aseptic/cleanroom conditions.

2.0 Scope

This SOP applies to the sanitization of walls, floors, ceilings, equipment, and accessories within the FFS area in the manufacturing unit at [Company Name].

3.0 Responsibility

4.0 Definitions

• FFS Area: A classified manufacturing zone where product is formed, filled, and sealed in containers.

• Sanitization: The process of applying disinfectants to reduce microbial load on surfaces.

• Disinfectant: A chemical agent used to destroy or inhibit the growth of microorganisms.

5.0 Materials and Equipment Required

• Approved disinfectants (e.g., 70% IPA, 0.2% Bacillocid, 1% Sodium Hypochlorite)

• Mop, mop bucket, wringer

• Lint-free cloths

• Spray bottles

• PPE: gloves, masks, gowns, goggles

• Sanitization logbook

• Fogger machine (if applicable)

6.0 Procedure

6.1 General Precautions

• Ensure personnel wear appropriate PPE before entry.

• Only trained staff should perform sanitization.

• Use freshly prepared disinfectant solutions.

• Record all sanitization activities in the logbook.

6.2 Daily Sanitization

1. Start of Shift:

   • Sanitize all surfaces, equipment, and walls with 70% IPA or an approved disinfectant using a lint-free cloth.

   • Mop the floor using disinfectant solution (alternate between agents as per rotation schedule).

   • Sanitize door handles, control panels, and frequently touched surfaces.

2. During Operation:

   • If spillage or contamination occurs, clean the area immediately and sanitize with 70% IPA.

   • Maintain cleanliness throughout the shift.

3. End of Shift:

   • Repeat complete area sanitization.

   • Mop the entire floor.

   • Sanitize external surfaces of equipment.

6.3 Weekly Sanitization

• Perform deep sanitization using fogger machine (if applicable).

• Disinfect hard-to-reach areas like ceilings, lighting panels, vents.

• Rotate disinfectants to prevent microbial resistance (e.g., use Bacillocid this week, Sodium Hypochlorite next week).

6.4 Monthly Sanitization

• Include walls, ceiling panels, air handling unit grills.

• Use a different validated disinfectant from daily/weekly routines.

• Conduct environmental monitoring (settle plates, swabs) post-sanitization.

7.0 Disinfectant Rotation Policy

• Use at least two to three disinfectants in a rotational schedule to reduce microbial resistance.

• Maintain records of rotation and chemical preparation.

8.0 Documentation

• Maintain a Sanitization Logbook for:

  • Date/time of sanitization

  • Area sanitized

  • Disinfectant used (name, concentration, expiry)

  • Name of personnel and verifier

9.0 Safety and Precautions

• Always wear PPE and avoid direct contact with disinfectants.

• Do not mix different disinfectants.

• Ensure proper ventilation while using chemicals.

• Discard expired or unused solutions safely.

10.0 Abbreviations

• SOP: Standard Operating Procedure

• FFS: Form-Fill-Seal

• PPE: Personal Protective Equipment

• IPA: Isopropyl Alcohol

• QA: Quality Assurance

11.0 Annexures

• Annexure 1: Daily Sanitization Checklist

• Annexure 2: Disinfectant Rotation Log

• Annexure 3: Monthly Deep Cleaning Record

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