Things to Consider When Validating Environmental Systems

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 clientcare@namsa.com.