STANDARD OPERATING PROCEDURE (SOP)

1.0 OBJECTIVE

To lay down the procedure for proper cleaning of the Fluidized Bed Dryer (FBD) bag to prevent cross-contamination and ensure compliance with cGMP requirements.

2.0 SCOPE

This SOP applies to all types of FBD bags (standard or anti-static) used in the production department of [Company Name].

3.0 RESPONSIBILITY

• Production Operator: Responsible for performing the cleaning activity.

• Production Supervisor: To ensure adherence to the procedure and proper documentation.

• Quality Assurance (QA): To verify and release cleaned FBD bags for use.

4.0 MATERIALS AND EQUIPMENT REQUIRED

• Clean, soft nylon brush

• Clean potable water and purified water

• Approved detergent (non-corrosive, non-residual)

• 70% Isopropyl Alcohol (IPA) (if applicable)

• Lint-free cloths

• Designated drying rack or drying area

• PPE: gloves, apron, mask, goggles

• FBD bag cleaning logbook/form

• Label tags (“Cleaned” / “To be cleaned”)

5.0 PROCEDURE

5.1 Precautions

• Handle the bag gently to avoid damage to filter mesh.

• Do not use sharp objects or metal brushes.

• Do not machine wash or dry unless validated.

• Wear PPE during the entire cleaning process.

5.2 Removal

1. Switch OFF the FBD and disconnect power supply.

2. Carefully detach the FBD bag from the container.

3. Label it as “To Be Cleaned”.

5.3 Cleaning Process

1. Dry Cleaning:

   • Shake the FBD bag gently in a designated area to remove loose powder.

   • Use a soft nylon brush to remove adhering dust.

2. Wet Cleaning (if applicable and validated):

   • Immerse the bag in a tank containing lukewarm water and approved detergent.

   • Soak for 10–15 minutes.

   • Gently agitate or hand-wash with soft scrubbing.

   • Rinse thoroughly with potable water followed by purified water.

   • Remove excess water by gentle squeezing.

3. Sanitization (if required):

   • Spray or wipe the bag with 70% IPA.

   • Allow to air dry completely.

5.4 Drying

1. Hang the FBD bag on a clean, labeled drying rack in a designated clean area.

2. Ensure full drying before reuse or storage.

3. Do not expose to direct sunlight or high temperatures unless specified.

5.5 Storage

1. After drying, inspect the bag for any damage or residual material.

2. Store in a clean, labeled polybag or stainless steel bin.

3. Affix a “Cleaned” label with date, time, and initials.

4. Maintain records in the FBD Bag Cleaning Logbook.

6.0 CLEANING FREQUENCY

• After each batch or product

• Before and after maintenance

• As per cleaning validation protocol

7.0 RECORDS TO BE MAINTAINED

• FBD Bag Cleaning Logbook

• Visual Inspection Checklist

• Cleaning and Status Tag

8.0 ABBREVIATIONS

• FBD: Fluidized Bed Dryer

• IPA: Isopropyl Alcohol

• PPE: Personal Protective Equipment

• SOP: Standard Operating Procedure

• cGMP: current Good Manufacturing Practice

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