SOP on Cleaning Policy of Area & Equipment

SOP on Cleaning Policy of Area & Equipment

Objective: To lay down the procedure for the Cleaning Policy of the Area & Equipment.

Scope: This Standard Operating Procedure is applicable to all the departments at the formulation plant of (Pharmaceutical Company Name).

Responsibility

  • The production Operator/ Technician shall be responsible for cleaning.
  • Production & QA Officer/ Executive shall be responsible for the implementation of SOP.

Accountability: QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • Critical Equipment: Equipment that comes directly in contact with the product.
  • ml: milliliters
  • Contaminants: Anything which is not included in the product processing.
  • SLS: Sodium Lauryl Sulphate

Procedure

Aspects of cleaning

All the equipment and area used during manufacturing shall be cleaned and sanitized at appropriate intervals. 

Cleaning of equipment:

There are two types of cleaning procedures for equipment used in manufacturing.

  • Type A Cleaning Procedure
  • Type B Cleaning Procedure

Type A cleaning procedure:

  • The equipment shall be dismantle first and dismantle part of equipment transfer to washing area.
  • In the washing area, the dismantled parts of equipment shall be cleaned with a cleansing agent i.e.0.5% w/w SLS or other cleaning aids (if required) as per the procedure mentioned in their respective SOPs for cleaning of equipment.
  • Non-dismantle part of equipment shall be cleaned in place as per their respective SOPs for cleaning of equipment.
  • A wash/Rinse water sample can be collected after visually verification by QA if specified in the respective SOP and sent to Quality Control along with sample request for determination of residual drug and cleansing agent.
  • Type A cleaning is applicable in the following conditions or cases:

Type A Cleaning

  • Product-to-product changes over.
  • Batch-to-batch changeover of the same product but from higher strength to lower strength.
  • Batch-to-batch changeover of the same product but a change in colour/ flavor.
  • After completion of five consecutive batches or completion of 120 hrs (i.e. validity of “Type – A” cleaning), whichever is earlier.
  • After any major breakdown where product contact parts are contaminated.
  • After completion of preventive maintenance work If product contact parts are disturbed/contaminated.

Type B cleaning procedure:

    • The equipment shall be cleaned without dismantling the equipment with a vacuum cleaner.
    • The equipment shall be mopped with clean moist lint-free cloth (moist with de-mineralized water) and later with a clean dry cloth.
    • Type B cleaning is applicable in the following conditions or cases.

Type B Cleaning

  • Batch-to-batch changeover of the same product having the same strength, same color, and same flavor
  • Batch to batch changes over but from lower strength to higher strength.
  • After completion of the batch.
  • After any minor breakdown, where product contact parts are not disturbed or contaminated as applicable.
  • Cleaning is done after the completion of preventive maintenance work. If product contact parts are not touched /disturbed/ contaminated clean as per “Type- B” cleaning.

General Instructions for cleaning of equipment:

  • All the equipment shall be cleaned as per respective SOPs of cleaning of equipment using a nylon brush and cleansing agent and then removing the cleansing agent with potable/Raw water and later rinsing with de-mineralized water.
  • Use a clean dry lint-free cloth or compressed air to dry the equipment.
  • After completion of the cleaning activity, the “CLEANED” status labels shall be filled by production personnel and attached to the equipment after that the QA personnel shall verify only after inspecting the equipment visually for cleanliness.
  • During Line clearance of equipment or before using the equipment, visually examine the equipment if found satisfactory then use it otherwise cleaning of the same shall be planned.
  • Hold Time for uncleaned equipment shall be not more than 72 hours and for cleaned equipment, the Hold time shall be 5 days from the date of cleaning of that equipment.

Note: For new equipment:

  • Equipment shall be passivated (if stainless steel material) as per the passivation protocols/ procedures, (if already not passivated by the vendor).
  • Removal of residual passivation agents shall be ensured by applying suitable analytical methodologies.
  • Cleaning of Area:

The area shall be cleaned according to the following types:

  • Type A cleaning:
  • Start the cleaning operation of ceiling and then to walls from top progressing to downwards.
  • Clean the door and window glasses using disinfectant solution with wet duster.
  • Clean the doors, door closures, handles and all the hinges of the door using dry followed by wet (with disinfectant) and again with dry duster.
  • If weighing balance is present in the processing room, clean it by using wet (with disinfectant) followed by dry duster.
  • Clean the pallets, trolleys, etc. using a wet (Disinfectant solution) followed by a clean dry duster.
  • Remove the dust from the switchboards, utility pendants using the vacuum cleaner and wipe with clean dry duster.
  • Clean the SOP stand using clean dry duster.
  • Clean the accessories box using the wet (Disinfectant solution) followed by clean dry duster.
  • Clean the ceilings of Air Handling Unit (AHU) supply/return grilles with a pipe brush and vacuum cleaner.
  • Clean and mop the entire floor twice using disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required) as per SOP.
  • Clean the tube light fixtures using wet (Disinfectant solution) followed by a clean dry duster.
  • Clean the coving, corners of the entire area using wet (Disinfectant solution) and followed by dry duster.
  • Clean the cameras of the entire area using wet (Disinfectant solution) followed by dry duster.
  • Clean the walls of the entire area using (Disinfectant solution) wet mop.
  • Collect all the waste from the waste bin into a poly bag and send to the scrap area. Clean the waste bin with wet (Disinfectant solution) followed by dry duster.
  • Clean the drain points using disinfectant solution.
  • Enter the cleaning activity details in the Cleaning Record Log Book.
  • The Type A Cleaning for area shall be done fortnightly.

Type B cleaning:

  • Clean the door and window glasses using wet (Disinfectant solution) and followed by dry duster.
  • Clean the doors, door closures, handles and all the hinges of the door using dry followed by wet (with disinfectant) and again with dry duster.
  • If weighing balance is present in the processing room, clean it by using wet duster (with disinfectant) followed by dry duster.
  • Clean the pallets, trolleys etc. using a wet duster (Disinfectant solution) followed by dry duster.
  • Clean the ceilings of Air Handling Unit (AHU) supply/return grilles with a pipe brush and vacuum cleaner.
  • Collect all the waste from the waste bin into a poly bag and send to scrap area. Clean the waste bin using wet duster (with disinfectant) followed by dry duster.
  • Clean and mop the entire floor twice using disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required) as per SOP.
  • Enter the cleaning activity details in the Cleaning Record Log Book.
  • The Type B Cleaning for area shall be done either at the end of the batch or at the end of the day whichever is earlier.
  • Daily cleaning  details of Area shall be filled as per Annexure – I

Forms and Records (Annexures)

Daily Area Cleaning Record – Annexure I

Distribution

    • Master copy – Quality Assurance
    • Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering & Human Resources.
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