Transcript What cleaning criteria are used?

Implants,
from cleaning to
sterilization
Dr. Abdess NAJI,
Consultant, Auditor
Medical Devices and Health Biotechnology
[email protected]
June 1st, 2012
IMPLANT-2012-Congress
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What cleaning criteria are used?
How can cleanliness be assessed?
Validating the cleaning processes used
New standards governing final cleaning:
how will the intermediary cleaning stage be affected?
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Definitions
 Cleaning : Action allowing to reach the lower organic
and/or inorganic residues level.
 Cleanliness : Surface quality of product where the organic
and/or inorganic residue level is lowest.
 Note : Do not confuse cleaning and disinfection
micro-organisms elimination or inhibition
Decontamination = cleaning + disinfection
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ISO 13485 : 2003 requirements
§ 7.5.2.1 - The organization shall validate any processes for
production and service provision where the resulting output
cannot be verified by subsequent monitoring or measurement.
This includes any processes where deficiencies become
apparent only after the product is in use or the service has
been delivered.
 Cleaning process validation is depending on its type, its
purpose and its related risks.
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Reference
 No specific standard available in Europe
 Standard published : XP S94-091 (September 2008) related to
“Implants for surgery Validation of the cleaning of orthopaedic implants before final conditioning”
 Guideline/Recommendations for cleaning process validation.
Some published guidance for pharmaceutical companies
 GMP Guidance - Europe
 FDA – 21 CFR 211 – Good Manufacturing Practices
 Document released by Health Canada :
‘’Directive on the validation of the cleaning processes’’
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Cleaning methods
1 - Decontamination = Cleaning + disinfection
2 - Rinsing
3 - Drying
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1- Decontamination : Cleaning + disinfection
Influence of :
• Material surface
• Irregularity, microscopic anfractuosities location
• Chemical composition of material : polymer, plastic, rubber,
metal, teflon
• Capacity of germ adhesion
• Biofilm formation
• Using of chemicals reagents and solvents :
• According to their activity spectrum
• According to their not-aggressiveness and compatibility
• Not containing aldehydes
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Manual cleaning:
• Steeping
• Brushing
• Ultrasounds using
Automatic cleaning:
• Avoid products handling
• Giving regularity in cleaning quality
Decontamination improves biocompatibility (non
toxicity) and sterilization process
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2- Rinsing
 Elimination of residues (organic substances, solvents ….)
• Using of city water
• Using of demineralised water
• Using of ultra filtered water
 The quality of water must be controlled:
• Maintenance of water installation
• Microbiological control/endotoxins
• Control water hardness (presence of limestone)
• TOC control
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3- Draining and drying
• Avoid bacterial development
• Avoid marks and imperfection
• Avoid condensation during sterilization
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Osteoblast attachement on hostile surface
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Cleaning process validation : Purpose
To eliminate organic and/or inorganic residues present on medical
device surface
But also:
To maintain cleaning process effectiveness all time
To guarantee cleaning reproducibility and homogeneity for all
manufactured batches
To apply cleaning procedures easily
To improve sterilization effectiveness
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How to validate?
Documented information :
 Identification of medical device physical and chemical
characteristics
(Geometry, constitution, porosity, used materials …)
 Identification of manufacturing processes
(before the cleaning process)
 Identification of surface state before cleaning
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General approach
Product family
Group of different product that can be
given the same cleaning effectiveness
- Definition of enclosure criteria :
– Raw material
– Surface state and geometric complexity
– Components
– Design and dimension of the product – Manufacturing process
– Manufacturing environment
– Production sites
Taken into account all the variables that impact the cleaning effectiveness.
- Designation of family representative product:
 Master product
 Equivalent product
 Simulated product
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How to validate?
Determination control method:
 Endotoxins rate
 Mineral pollution
 Organic pollution
 Visual aspect
 Residues toxicity
…
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How to validate?
Cleaning process selected :
 Selection of adapted cleaning equipment
 Selection of adapted cleaning method
Selection of active products or cleaning agents
Determination of rinsing condition (to eliminate cleaning
products and/or residues)
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How to validate?
Follow process validation methodology :
 Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance Qualification (PQ)
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How to control products?
Critical parameter measurement :
 Pyrogen test (Endotoxines control)
Soluble and non soluble organic components
TOC Rate (Total Organic Carbon),
 Heavy metal measurement
 Control water hardness (limestone presence) and conductivity
 Mineral residues
 Impact on passivation if needs
 Cytotoxicity tests
…
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How to control the process?
Using adapted procedures to control:
 Equipments and infrastructure maintenance
 Staff qualification and training
 Environmental conditions
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Cleaning process : Modification
Every cleaning process modification should be validated:
could affect process effectiveness and reproducibility
 Raw material changes
 Component or surface state change
 Manufacturing equipment change
 Manufacturing work environment change
 Manufacturing process change
 Cleaning product change
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Cleaning process : Modification
Methodology :
 Evaluation of any possible impact on risk management
 Determination if any new qualification must be done
 All re-qualifications must be documented
 If modification is not followed by any actions, the justification
shall be documented
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Thank you for your attention.
Dr. Abdess NAJI
Auditor / Expert
Consultant
MATIERE & SANTE
4, rue Paul Nizan
33140 VILLENAVE D'ORNON-FRANCE
Tel/Fax : +33 5.56.87.88.91
Mobile : +33 6.16.41.25.01
E-mail : [email protected]
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