Cleaning Validation Technologies
Destin A. LeBlanc-Technical Consulting Services
CLEANING MEMO TOPIC INDEX Note: This topic index is valid for Cleaning Memos through December 2019. 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: 12/18; 6/17; 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: 3/19; 9/17; 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: 10/19; 9/18; 10/17; 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 Equipment – new and used: 4/18 GRAS: 7/15 Grouping – Equipment: 6/14; 11/12; 8/01 Grouping – Product: 7/19; 11/17; 5/17; 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): 4/19; 3/18; 12/17; 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: 8/18; 7/18; 6/18; 2/18; 01/18; 12/17; 8/17; 7/17; 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: 1/19; 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: 1/19; 5/18; 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: 12/19; 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: 01/18; 12/17; 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: 12/19; 11/19; 10/15; 12/09; 2/09; 1/09; 4/06; 11/05; 11/04; 9/03; 9/02 Sampling – swab: 10/18; 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 Terminology usage: 7/19, 6/19, 5/19, 12/18/, 9/12 Test Until Clean: 3/14 Topicals: 11/08 Unknown peaks: 2/05 Validation maintenance: 11/09 Visually clean: 9/19; 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 |