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PROCEDURE FOR CONTAMINATION CONTROL
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CHAPTER TOPIC PAGE NO
1. PURPOSE 4
2. SCOPE 4
3. USERS OR RESPONSIBILITY 4
4. DEFINITIONS 5
5. ABBREVATIONS 5
6. REFERENCES 6
7. PROCEDURE 6
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LIST OF ANNEXURES
ANNEXURE
NO. DESCRIPTION
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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1. PURPOSE
To establish and maintain effective contamination control measures for the protection of
the product, personnel, and work environment, particularly in the manufacture of sterile
medical devices, in accordance with ISO 13485:2016.
2. SCOPE
This procedure applies to all production, assembly, storage, and packaging activities
where contamination could impact product safety, performance, or sterility.
3. RESPONSIBILITIES
Quality Assurance Manager: Ensures contamination control protocols are
established, documented, and followed.
Production Manager: Implements contamination control procedures during
manufacturing and assembly.
All Personnel: Comply with contamination control practices and report deviations or
contamination events.
4. DEFINITIONS
Contamination: The presence of an unwanted substance or organism on a product,
equipment, or surface.
Sterile Medical Devices: Devices that are free from viable microorganisms.
Particulate Matter: Microscopic solid or liquid matter suspended in the air that can
contaminate products.
5. PROCEDURE
5.1 PLANNING AND DOCUMENTATION
Establish a contamination control plan for all relevant operations, documented in
the QMS.
Identify contamination risks and define control measures.
Maintain documentation of procedures, inspections, and corrective actions.
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5.2 CONTROL OF CONTAMINATED PRODUCTS
Clearly label and isolate any contaminated or potentially contaminated products.
Assess the risk of contamination spread and document containment actions.
Record incidents and escalate for investigation and corrective action as required.
5.3 CLEANLINESS REQUIREMENTS FOR STERILE DEVICES
Implement particulate and microbial control in cleanrooms used for assembly
or packaging of sterile devices.
Ensure environmental monitoring is performed regularly and results are
documented.
Define gowning procedures, air quality controls, and material handling
protocols.
5.4 PERSONNEL AND WORK ENVIRONMENT HYGIENE
Personnel must follow personal hygiene protocols and wear appropriate PPE.
Restricted access to clean zones must be enforced.
Regular cleaning and sanitization of work areas must be scheduled and
recorded.
5.5 EQUIPMENT AND TOOLING
Clean and disinfect equipment and tools before use in contamination-sensitive
processes.
Maintain calibration and maintenance records to ensure equipment
cleanliness.
6. RECORDS
Contamination control plans.
Environmental monitoring logs.
Incident and deviation reports.
Cleaning and sanitization records.
Training records for contamination control procedures.
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7. REFERENCES
ISO 13485:2016 – Quality Management Systems for Medical Devices.
Internal SOPs for environmental monitoring and cleanroom management.
Regulatory requirements applicable to sterile product manufacturing.
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