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Procedure_for_Contamination_Control

The document outlines the procedure for contamination control in the manufacture of sterile medical devices, ensuring product safety and compliance with ISO 13485:2016. It details responsibilities, definitions, and specific control measures for contamination risks, including planning, cleanliness requirements, personnel hygiene, and equipment maintenance. Additionally, it emphasizes the importance of documentation and record-keeping for effective contamination management.

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28 views8 pages

Procedure_for_Contamination_Control

The document outlines the procedure for contamination control in the manufacture of sterile medical devices, ensuring product safety and compliance with ISO 13485:2016. It details responsibilities, definitions, and specific control measures for contamination risks, including planning, cleanliness requirements, personnel hygiene, and equipment maintenance. Additionally, it emphasizes the importance of documentation and record-keeping for effective contamination management.

Uploaded by

rengasri13953
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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(Company Name) No
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PROCEDURE FOR Eff DD-MM-
CONTAMINATION Date YYYY
CONTROL Page 1 of 8

(Company logo)

PROCEDURE FOR CONTAMINATION CONTROL


(Company Name)

(Address)

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(Name and Designation) (Name and Designation) (Name and Designation)


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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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(Name and Designation) (Name and Designation) (Name and Designation)


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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.

Prepared By: Issued By: Approved By:

(Name and Designation) (Name and Designation) (Name and Designation)


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PROCEDURE FOR Eff DD-MM-
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CONTROL Page 5 of 8

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(Name and Designation) (Name and Designation) (Name and Designation)


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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.
Prepared By: Issued By: Approved By:

(Name and Designation) (Name and Designation) (Name and Designation)


FUNC MR
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(Company Name) No
Rev
(Company Logo) 00 Issue 01
PROCEDURE FOR Eff DD-MM-
CONTAMINATION Date YYYY
CONTROL Page 7 of 8

Prepared By: Issued By: Approved By:

(Name and Designation) (Name and Designation) (Name and Designation)


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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.

Prepared By: Issued By: Approved By:

(Name and Designation) (Name and Designation) (Name and Designation)

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