Cleaning Policy of Area and Equipment in Pharma Industry

Cleaning Policy of Area and Equipment in Pharma Industry

• Objective

          To lay down the procedure for Cleaning Policy of Area & Equipment in Pharma Industry.

• Scope

This Standard Operating Procedure is applicable to all the departments at the formulation plant in Pharma Industry.

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

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

• Abbreviations and Definitions

SOP: Standard Operating Procedure

QA: Quality Assurance

Critical Equipment’s : Equipments that comes directly in contact of product.

Area: Include Floors, walls, ceilings.

ml : milliliters

Contaminants : Anything which is not included in the product processing.

SLS: Sodium Lauryl Sulphate

• Procedure in Pharma Industry
  • Aspects of cleaning in Pharma Industry
    • All the equipments and area used during manufacturing shall be cleaned and sanitized at appropriate intervals.

• Cleaning of equipment in Pharma Industry:
  • There are two types of cleaning procedure for equipment used in manufacturing.
• Type A Cleaning Procedure
• Type B Cleaning Procedure

• Type A cleaning procedure in Pharma Industry:
  • The equipment shall be dismantle first and dismantle part of equipment transfer to washing area.
  • In washing area the dismantled parts of equipment shall be cleaned with cleansing agent i.e.0.5% w/w SLS or other cleaning aids (if required) as per 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:

Cleaning Type	Description
Type A Cleaning	Product to product changes over.
	Batch to batch changeover of same product but from higher strength to lower strength.
	Batch to batch changeover of same product but change in colour/ flavor.
	After completion of five consecutive batches or completion of 108 hrs (i.e. validity of “Type – A” cleaning), whichever is earlier.
	After any major break down where product contact parts are contaminated.
	After completion of preventive maintenance work If product contact parts are disturbed / contaminated.

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

Cleaning  Type	Description
Type B Cleaning	Batch to batch change over of the same product having same strength, same color and same flavor
	Batch to batch change 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 done after 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’s in Pharma Industry:
  • All the equipment’s shall be cleaned as per respective SOPs of cleaning of equipment’s using nylon brush and cleansing agent and then removing the cleansing agent with potable/Raw water and later rinse with de-mineralized water.
  • Use clean dry lint free cloth or compressed air to dry the equipment.
  • After completion of cleaning activity, the “CLEANED” status labels shall be filled by production personnel and attached on equipment after that the QA personnel shall verified 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’s shall be not more than 72 hours and for cleaned Equipments 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 agent shall be ensured by applying suitable analytical methodologies.

• Cleaning of Area in Pharma Industry:

The area shall be cleaned according to the following types:

• Type A cleaning in Pharma Industry:
  • 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/QA-037.
  • 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 in Pharma Industry:
  • 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/QA-037.
  • 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.

• History 

Date	Revision Number	Reason for Revision
–	–	New SOP

Annexure-I

Daily Area Cleaning Record

S.No.	Date	Time		Section	Area	Done  By	Checked By	Remarks
		Morning	Evening