Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

CLEANING MEMO TOPIC INDEX

Note: This topic index is valid for Cleaning Memos through April 2017. The monthly

issues are listed as month/year; for example, May 2007 is given as “5/07”. The list below

does not necessarily reflect every time a topic might be mentioned. This topic index is

meant to provide a list of Cleaning Memos where a given topic was covered in a

significant way.

Analytical method validation: 9/07; 2/07; 2/01

Analytical methods: 8/13; 7/13; 5/12; 11/11; 10/11; 9/11; 1/08; 7/06; 6/06; 2/05; 8/04;

1/01

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: 4/17; 6/12; 2/12; 4/08; 1/07; 9/06; 3/06; 2/06; 11/01

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: 4/12; 2/10; 11/09; 8/08; 1/08; 4/01

Clinical trials: 5/01; 4/01

Continuous manufacture: 9/16; 4/14

Dedicated equipment: 5/12; 1/06; 11/00

Design/development of cleaning processes: 12/14; 9/09; 8/06; 1/05

Dirty Hold Time: 4/17; 2/12; 12/06; 1/03; 10/01

Endotoxin issues: 2/04

GRAS: 7/15

Grouping – Equipment: 6/14; 11/12; 8/01

Grouping – Product: 10/04; 7/01

Highly Hazardous Actives: 2/15; 6/12

History (of cleaning validation): 2/08

Indirect product contact surfaces: 10/14; 9/14; 8/14; 10/00

Limits (general): 12/16; 11/16; 7/16; 3/13; 10/12; 9/12; 11/11; 10/11; 9/11; 4/11; 5/09;

3/09; 11/08; 10/08; 1/08; 12/07; 1/06; 6/05; 3/02; 2/02; 1/02

Limits – actives: 10/16; 6/03; 12/01; 5/01

Limits – ADE: See “Risk-MaPP” and “Limits – health-based”

Limits – PDE: See “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: 7/05; 5/02

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: 4/09; 7/02

Protocols: 2/16; 3/11; 8/08; 3/06; 3/04; 7/03

Recovery (general): 6/10; 9/08; 4/08; 7/07; 6/04; 2/03; 12/02; 11/02; 9/01

Recovery – bioburden sampling: 6/02

Recovery – rinse sampling: 10/13; 1/13; 10/02

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: 6/15; 3/11; 12/10; 8/09; 7/08; 3/08; 1/05; 7/03; 3/01

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: 8/16; 5/05; 4/04; 4/03

Sampling – bioburden: 4/08; 5/06

Sampling hold time: 2/12

Sampling – rinse: 10/15; 12/09; 2/09; 1/09; 4/06; 11/05; 11/04; 9/03; 9/02

Sampling – swab: 10/15; 1/10; 10/09; 11/06; 12/05; 11/05; 9/03; 3/03; 8/02

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: 12/15; 1/15; 9/10; 8/10; 7/10; 9/04; 3/03; 4/02

Water activity: 7/12

Water quality: 6/01

White rings (buffer tanks): 11/14