Life Science and Pharmaceutical
The exceptionally strict regulations in the life sciences industry call for extremely reliable measurement methods. When used continuously, they ensure that production faults are identified quickly.
The most important element in clean room production is to ensure that no products are contaminated during the manufacturing process. It is also vital that employees are protected from harmful substances and that products or their components are not released into the wastewater.
There are technical solutions for taking regular measurements of the following parameters:
- Airborne particles in the clean room
- Particles in syringes, ophthalmic solutions and ultra-pure water
- TOC (total organic carbon) in ultra-pure water and WFI (water for injection) plants
- Ozone for sanitisation in ultra-pure water plants
- Dissolved oxygen in the production process and in the headspace of semi-finished and finished products
Many of the parameters that need to be monitored form part of the routine quality controls and are monitored both during the manufacturing process and in the finished product. Stringent quality standards need to be observed in the pharmaceutical and biotechnology industry and all relevant directives and standards such as ISO, EU GMP, cGMP and the respective pharmacopoeias need to be met.