Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

Cleaning Memo Topic Index


Analytical method validation:

Analytical methods:

Analytical methods – TOC:

  • 5/12

  • 10/07

  • 9/07

  • 12/04

  • 6/04

  • 5/04

  • 4/04

  • 11/03

  • 8/03

API manufacture:

  • 1/17

  • 6/16

  • 5/16

  • 4/16

  • 12/07

Biotech issues:

  • 6/09

  • 9/08

  • 4/07

  • 3/07

  • 6/05

  • 5/03

Campaigns:

  • 5/12

  • 1/11

  • 6/07

  • 11/00

Clean Hold Time:

Cleaning agents:

  • 5/12

  • 12/09

  • 6/09

  • 4/08

  • 9/05

  • 8/05

Cleaning procedure:

  • 9/16

  • 1/16

  • 11/15

  • 12/10

  • 8/06

  • 1/05

Cleaning verification:

Clinical trials:

Continuous manufacture:

  • 4/14

Dedicated equipment:

Design/development of cleaning processes:

  • 12/14

  • 9/09

  • 8/06

  • 1/05

Dirty Hold Time:

Endotoxin issues:

  • 2/04

GRAS:

  • 7/15

Grouping – Equipment:

Grouping – Product

Highly Hazardous Actives:

  • 2/15

  • 6/12

History (of cleaning validation):

  • 2/08

Indirect product contact surfaces:

Limits (general):

Limits – actives:

Limits – ADE:

  • “Risk-MaPP”

  • “Limits – health-based”

Limits – PDE:

  • “Limits – health-based”

Limits – bioburden:

  • 2/07

  • 5/05

Limits – biotech:

  • 3/17

  • 2/17

  • 4/07

  • 3/07

Limits – cleaning agents:

  • 1/14

  • 11/07

  • 9/05

  • 8/05

Limits – health-based:

  • 7/16

  • 3/16

  • 9/15

  • 8/15

  • 5/15

  • 4/15

  • 3/15

  • 5/14 addendum;

  • 12/13

  • 11/13

  • 5/13

  • 3/12

Limits – preferential transfer:

  • 7/14

Limits – rinse sampling:

  • 5/13

  • 4/13

  • 2/09

  • 1/09

  • 4/08

  • 10/05

Limits – swab sampling:

  • 11/05

Limits – stratified sampling:

  • 5/10

  • 4/10

  • 3/10

Limits – TTC:

  • 5/07

Lyophilizers:

  • 10/14

  • 9/14

  • 8/14

Manual cleaning issues:

  • 7/11

  • 6/11

Master plans:

  • 8/07

Media fills:

  • 7/04

Medical devices:

Mock Soil/Soiling:

  • 2/14

Monitoring:

  • 8/13

  • 7/13

  • 1/04

Non-product contact surfaces:

  • 6/08

  • 5/08

  • 10/06

Packaging (filling) equipment:

  • 4/05

  • 3/05

Parts washer:

  • 1/12

PAT (continuous process verification):

  • 11/09

  • 10/03

Placebo cleaning:

  • 9/16

Placebo sampling:

  • 8/16

Process validation:

  • 8/12

  • 3/11

  • 11/09

  • 8/09

Protocol worst cases:

Protocols:

  • 2/16

  • 3/11

  • 8/08

  • 3/06

  • 3/04

  • 7/03

Recovery (general):

Recovery – bioburden sampling:

Recovery – rinse sampling:

Recovery – solvent reflux sampling:

  • 12/08

Recovery – swab sampling:

  • 9/13

  • 12/12

  • 8/11

  • 5/11

  • 10/10

  • 6/10

  • 10/09

  • 7/09

Recovery for volatiles:

  • 5/14

Regulatory documents/issues:

Revalidation:

  • 7/08

  • 12/03

Risk MaPP:

  • 2/13

  • 10/12 addendum

  • 3/12

  • 12/11

  • 7/11 addendum

  • 2/11

  • 11/10

  • 5/09

  • 10/08

Sampling:

  • 5/05

  • 4/04

  • 4/03

Sampling – bioburden:

  • 4/08

  • 5/06

Sampling hold time:

  • 2/12

Sampling – rinse:

Sampling – swab:

SIP:

  • 9/06

  • 5/06

Solvents (organic):

  • 11/07

Statistics:

  • 7/10

  • 6/10

  • 11/05

  • 4/03

Test Until Clean:

  • 3/14

Topicals:

  • 11/08

Unknown peaks:

  • 2/05

Validation maintenance:

  • 11/09

Visually clean:

Water activity:

  • 7/12

Water quality:

White rings (buffer tanks):

  • 11/14


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