Laboratory Investigations

Bactimm carries out method development and validation studies according to international guidelines, using standard validation packages in conformity with ICH guidance.

A validation project, executed as per GLP guidelines, comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report.

Validation studies are performed by dedicated staff with special training on study handling, in accordance with international guidelines, such as PhEur, USP and ICH.

Standard Throughput times are between 6-8 weeks. Please contact us for sample reports and more information.

Stability Studies are performed in temperature/humidity controlled and monitored cabinets in compliance with ICH or ASTM guidelines. Standard chamber conditions include:

• 25°C ± 2°C / 60% RH ± 5&#37
• 30°C ± 2°C / 65&#37 RH ± 5&#37
• 40°C ± 2°C / 75&#37 RH ± 5&#37