SOP for Cleaning and Maintenance of Nebulizer Component Molds

Standard Operating Procedure for Cleaning and Maintaining Molds Used in Nebulizer Component Manufacturing

1) Purpose

The purpose of this SOP is to outline a standardized procedure for cleaning and maintaining molds used in the manufacturing of nebulizer components, ensuring product quality and extending mold lifespan.

2) Scope

This SOP applies to all molds used in the production of nebulizer components within the manufacturing facility.

3) Responsibilities

Operators: Perform cleaning and inspection of molds as per this SOP.
Maintenance Team: Conduct routine and preventive maintenance of molds.
Quality Assurance (QA): Verify the cleaning and maintenance process and approve related records.

4) Procedure

4.1 Pre-Cleaning Preparation

Inspect the mold for any visible residue, damage, or contamination before cleaning.
Ensure all required cleaning tools and agents, such as brushes, cloths, and cleaning solutions, are available and validated for use.
Wear appropriate personal protective equipment (PPE), including gloves, goggles, and lab coats.

4.2 Cleaning Process

Disassemble the mold, if possible, to clean individual components thoroughly.
Remove loose particles and debris using a soft brush or compressed air.
Prepare the cleaning solution as per the manufacturer’s recommendations and apply it to the mold surfaces.
Scrub the mold surfaces gently using non-abrasive tools to avoid damage.
Rinse the mold

thoroughly with purified water to remove all cleaning agent residues.

Perform a final rinse with deionized or distilled water to ensure no contaminants remain.

4.3 Drying Process

Wipe the mold with a lint-free cloth to remove excess water.
Allow the mold to air dry in a clean, dust-free area or use a drying oven if necessary.
Ensure the mold is completely dry before reassembly or storage to prevent rust or corrosion.

4.4 Maintenance Activities

Inspect the mold for signs of wear, such as cracks, dents, or deformities, during each cleaning cycle.
Lubricate moving parts or contact surfaces using mold-specific lubricants to reduce wear and tear.
Polish mold cavities and surfaces periodically to maintain their integrity and ensure smooth operation.
Document all maintenance activities in the Mold Maintenance Log.

4.5 Post-Cleaning Inspection

Inspect the cleaned and dried mold for residues, damage, or contamination.
Reassemble the mold carefully and perform a test run if applicable.
Label the mold with the cleaning date, next due date, and operator initials.
Record the cleaning process details in the Mold Cleaning Log.

4.6 Frequency of Cleaning and Maintenance

Routine Cleaning: After every production batch.
Deep Cleaning: Weekly or after extended production cycles.
Preventive Maintenance: Monthly or as recommended by the manufacturer.

4.7 Safety Precautions

Handle cleaning agents as per their Material Safety Data Sheets (MSDS).
Ensure all electrical connections are safe when using drying ovens or powered tools.
Follow lockout/tagout (LOTO) procedures during mold maintenance.

5) Abbreviations

QA: Quality Assurance
PPE: Personal Protective Equipment
LOTO: Lockout/Tagout
MSDS: Material Safety Data Sheet

6) Documents

The following documents should be maintained:

Mold Cleaning Log
Mold Maintenance Log
Mold Inspection Report

7) References

Relevant regulatory guidelines and references include:

ISO 13485: Medical Devices Quality Management Systems
Good Manufacturing Practices (GMP) Guidelines
Equipment Manufacturer’s Manual

8) SOP Version

Version: 1.0

Annexure

Annexure Title: Mold Cleaning Log

   Date  Mold ID  Batch No.  Cleaning Agent Used  Operator Initials  Remarks  
  DD/MM/YYYY  Mold Identifier  Batch Identifier  Agent Name  Operator Name  Details of cleaning

Date	Mold ID	Batch No.	Cleaning Agent Used	Operator Initials	Remarks
DD/MM/YYYY	Mold Identifier	Batch Identifier	Agent Name	Operator Name	Details of cleaning

Annexure Title: Mold Maintenance Log

   Date  Mold ID  Maintenance Type  Performed By  QA Approval  Remarks  
  DD/MM/YYYY  Mold Identifier  Routine/Deep/Preventive  Technician Name  QA Name  Details of maintenance

Date	Mold ID	Maintenance Type	Performed By	QA Approval	Remarks
DD/MM/YYYY	Mold Identifier	Routine/Deep/Preventive	Technician Name	QA Name	Details of maintenance

Annexure Title: Mold Inspection Report

   Date  Mold ID  Condition Observed  Corrective Action  Performed By  QA Approval  
  DD/MM/YYYY  Mold Identifier  Condition Description  Action Taken  Technician Name  QA Name

Date	Mold ID	Condition Observed	Corrective Action	Performed By	QA Approval
DD/MM/YYYY	Mold Identifier	Condition Description	Action Taken	Technician Name	QA Name