Your project: | Cleaning Validation |
Specifications: | German Drug Law, AMWHV, EU-guideline, PIC, ICH-Q2A, DIN 32645, 1994-05 |
Subject: | Risk analysis evaluation of worst-case products consideration of residues down to the ppbs and ppts acceptance criteria analytical support on-going monitoring |
Methods: | HPLC, Ph. Eur. 2.2.29 UV, Ph. Eur. 2.2.25 TOC, Ph. Eur. 2.2.44 among others. pH-value and Conductivity, Ph. Eur. 2.2.3/2.2.38 |
Our competence: | Cleaning validation master plan, standard operation procedure “swabbing” standard operation procedure “rinsing” standard operation procedure “method validation” know-how regarding TOC know-how regarding detergents method validation: HPLC, UV, TOC among others trace analysis application of special analysis techniques training of the samplers logistics around sampling interpretation of results consultancy in the whole area. |