Your project: Cleaning Validation
Your deadlines: On short notice
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.
Your dialogue partner: Arno Bayerl, food chemist
Tel: 0049 (0)7251 72484-04
Fax 0049 (0)7251 72484-29
info(Replace this parenthesis with the @ sign)techpharm.de

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