Cleaning Policy of Area & Equipment SOP

Cleaning Policy of Area & Equipment SOP

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

Scope: This Standard Operating Procedure applies to all the departments at the formulation plant.

Responsibility :

The production Operator/ Technician shall be responsible for cleaning.

Production & QA Officer/ Executive shall be responsible for the implementation of SOP.

Accountability: The 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 that is not included in the product processing.
  • SLS: Sodium Lauryl Sulphate

Procedure :

Aspects of cleaning

All the equipment and areas 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 dismantled first and part of the equipment transferred to the 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 parts 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 visual verification by QA if specified in the respective SOP and sent to Quality Control along with a 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 color/ 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 a 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 the ceiling and then to walls from top progressing to downwards.

Clean the door and window glasses using a disinfectant solution with a 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 a dry duster.

If weighing balance is present in the processing room, clean it by using a wet (with disinfectant) followed by a dry duster.

Clean the pallets, trolleys, etc. using a wet (Disinfectant solution) followed by a clean dry duster.

Remove the dust from the switchboards, and utility pendants using the vacuum cleaner and wipe with a clean dry duster.

Clean the SOP stand using a clean dry duster.

Clean the accessories box using the wet (Disinfectant solution) followed by a clean dry duster.

Clean the ceilings of the Air Handling Unit (AHU) supply/return grilles with a pipe brush and vacuum cleaner.

Clean and mop the entire floor twice using a disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required) as per SOP.

Clean the tube light fixtures using a wet (Disinfectant solution) followed by a clean dry duster.

Clean the coving, corners of the entire area using a wet (Disinfectant solution) and followed by a dry duster.

Clean the cameras of the entire area using a wet (Disinfectant solution) followed by a dry duster.

Clean the walls of the entire area using a disinfectant solution) wet mop.

Collect all the waste from the waste bin into a poly bag and send it to the scrap area. Clean the waste bin with a wet (Disinfectant solution) followed by a dry duster.

Clean the drain points using the disinfectant solution.

Enter the cleaning activity details in the Cleaning Record Log Book.

The Type A Cleaning for the area shall be done fortnightly.

SILVER SULPHADIAZINE AND CHLORHEXIDINE CREAM

Type B cleaning:

Clean the door and window glasses using a wet (Disinfectant solution) followed by a 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 a dry duster.

If a weighing balance is present in the processing room, clean it by using a wet duster (with disinfectant) followed by a dry duster.

Clean the pallets, trolleys, etc. using a wet duster (Disinfectant solution) followed by a dry duster.

Clean the ceilings of the 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 it to the scrap area. Clean the waste bin using a wet duster (with disinfectant) followed by a dry duster.

Clean and mop the entire floor twice using a 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 the 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 the Area shall be filled

Forms and Records (Annexures)

Daily Area Cleaning Record

Distribution

Master copy – Quality Assurance

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

Good Documentation Practices SOP

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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