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This presentation discuses the general validation requirements for the various elements that are regularly used by Medical Device Manufacturers to control their manufacturing environment.
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Things to Consider when Validating
Environmental Systems
Richard Granquist
Medical Research Manager
NAMSA
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The Purpose of
Environmental
Systems
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For starters,
You can manage
environmental conditions.
Such as:
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For starters,
You can manage
environmental conditions.
Such as:
Temperature
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For starters,
You can manage
environmental conditions.
Such as:
Temperature
Humidity
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For starters,
You can manage
environmental conditions.
Such as:
Temperature
Humidity
pH Levels
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For starters,
You can manage
environmental conditions.
Such as:
Temperature
Humidity
pH Levels
Water Hardness
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You can also control
contamination.
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You can also control
contamination.
Airborne Particulates
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You can also control
contamination.
Airborne Particulates
Chemical Factors
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You can also control
contamination.
Airborne Particulates
Chemical Factors
Microorganisms
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You can also control
contamination.
Airborne Particulates
Chemical Factors
Microorganisms
Endotoxin
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The Big Three
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What are the big three?
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The big three are the main
environmental systems to be
taken into consideration, but not
the only.
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The big three are the main
environmental systems to be
taken into consideration, but not
the only.
HVAC
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The big three are the main
environmental systems to be
taken into consideration, but not
the only.
HVAC
Water
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The big three are the main
environmental systems to be
taken into consideration, but not
the only.
HVAC
Water
Compressed Air or Gasses
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Other systems include:
Vacuum Systems
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Other systems include:
Vacuum Systems
Pressurized Gas Tanks
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Other systems include:
Vacuum Systems
Pressurized Gas Tanks
Laminar Flow Hoods
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Other systems include:
Vacuum Systems
Pressurized Gas Tanks
Laminar Flow Hoods
Biological Safety Cabinets
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Things to consider:
Product Needs
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Things to consider:
Product Needs
Equipment Needs
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Things to consider:
Product Needs
Equipment Needs
Employee Needs
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Things to consider:
Product Needs
Equipment Needs
Employee Needs
Local Factors
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Things to consider for HVAC:
Cleanroom or Controlled Environment
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Things to consider for HVAC:
Cleanroom or Controlled Environment
Employee Concentration
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Things to consider for HVAC:
Cleanroom or Controlled Environment
Employee Concentration
Equipment/Materials
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Things to consider for HVAC:
Cleanroom or Controlled Environment
Employee Concentration
Equipment/Materials
Building Layout and Product Flow
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Things to consider for HVAC:
Cleanroom or Controlled Environment
Employee Concentration
Equipment/Materials
Building Layout and Product Flow
Installment of all HEPA filters
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Things to consider for HVAC:
Cleanroom or Controlled Environment
Employee Concentration
Equipment/Materials
Building Layout and Product Flow
Installment of all HEPA filters
Perform “As Built” testing
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Things to consider for HVAC:
Cleanroom or Controlled Environment
Employee Concentration
Equipment/Materials
Building Layout and Product Flow
Installment of all HEPA filters
Perform “As Built” testing
ISO 14644-1:1999 Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness
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Things to consider for Water Systems:
Water Source
Well or Reservoir?
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Things to consider for Water Systems:
Water Source
Well or Reservoir?
Water Quality
What is the pH level?
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Things to consider for Water Systems:
Water Source
Well or Reservoir?
Water Quality
What is the pH level?
What is the hardness of the water?
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Things to consider for Water Systems:
Water Source
Well or Reservoir?
Water Quality
What is the pH level?
What is the hardness of the water?
Are there other chemical characteristics?
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Things to consider for Water Systems:
Water Source
Well or Reservoir?
Water Quality
What is the pH level?
What is the hardness of the water?
Are there other chemical characteristics?
Water Usage
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Things to consider for Water Systems:
Water Source
Well or Reservoir?
Water Quality
What is the pH level?
What is the hardness of the water?
Are there other chemical characteristics?
Water Usage
Regional Pharmacopeias (e.g. USP)
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A great resource that explains water
system validations can be found at: http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1231.html
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Things to consider for Processed
Compressed Air Systems:
Maximal Usage
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Things to consider for Processed
Compressed Air Systems:
Maximal Usage
Type of Air Compressor
Oil lubricated or oil-less?
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Things to consider for Processed
Compressed Air Systems:
Maximal Usage
Type of Air Compressor
Oil lubricated or oil-less?
End Point Filtration or Inline Filtration?
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Things to consider for Processed
Compressed Air Systems:
Maximal Usage
Type of Air Compressor
Oil lubricated or oil-less?
End Point Filtration or Inline Filtration?
Does this come into contact with your
product?
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Things to consider for Processed Compressed Air Systems:
Maximal Usage
Type of Air Compressor Oil lubricated or oil-less?
End Point Filtration or Inline Filtration?
Does this come into contact with your product?
ISO 8573-1:2010 Compressed air – Part 1: Contaminants and purity classes
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To view the complete Remote Training Series on Things to Consider When Validating Environmental Systems
Check out NAMSA’s Seminars
For information about the services NAMSA can offer you regarding Environmental Systems
Visit our Environmental Monitoringpage
For additional information
Contact us at [email protected].
