Techniconsult
Contained. Monitored. Safe.
Techniconsult’s corporate organisation includes a specific Business Unit for Containment Test & monitoring which verifies containment performance in the production of active substances, intermediates and preparations, to guarantee the safety and protection of staff, products (cross-contamination) and the environment.
During recent years the worldwide pharmaceutical industry has increasingly tended to develop highly potent molecules (HPAPIs): the global API market grew constantly by 5.1% from 2007 to 2020 and annual expansion of 8.7% is forecast from 2022 to 2027.
This places even more focus not only on GMP quality requirements but also on occupational safety and environmental protection regulations.
Containment Test activities
The purpose of containment tests on pharmaceutical activities is to assess their efficacy in containing the particulate material processed inside them, operating in real, representative conditions in a worst-case scenario.
The ISPE Good Practice Guides: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (SMEPAC).
The main activities involved in the containment test are:
- Assessment & Planning
- On field monitoring
- Laboratory Analysis
- Data Analysis & reporting
The outcomes of containment test activities are essential for raising companies’ internal awareness regarding the containment of their processes, comparing the various technological and procedural solutions applied on the basis of real, measured data and supporting decision-making processes which aim to improve performance.
Containment tests are a fundamental tool, systematically used by pharmaceutical companies, CDMOs and equipment vendors.
Monitoring activities
Techniconsult supplies monitoring and analysis services to chemical and pharmaceutical companies for the assessment of occupational exposure to APIs /HPAPIs, Isolated Process Intermediates (IPIs), process chemicals and solvents.
The main monitoring activities are:
- Analytical method validation
- Sampling method validation
- On field monitoring
- Laboratory Analysis
- Data Analysis & reporting
The outcomes of industrial hygiene monitoring are a key reference in the assessment of chemical and carcinogen risks in workplaces for chemical and pharmaceutical companies, CMOs & CDMOs.