무결성 테스터

The Integritest^® 5 delivers a simple and intuitive user experience, while providing optional depth of flexibility to fit your process.

Our IQ/OQ service ensures that the installation and operational qualification of your Integritest® 5 system is fully documented.

Select and manage the spare parts required for your system, our experts have performed a risk assessment to determine which parts to keep in stock.

The Exact-Air™ II System, paired with the Integritest® 5 tester, uses the HydroCorr™ method, a highly sensitive water-based integrity test for hydrophobic membrane filters.

Maintain optimal performance and minimize downtime and manage the spare parts required for your system, our experts have performed a risk assessment to determine which parts to keep in stock.

Investigational New Drug (IND) applications must contain information allowing an assessment of whether or not the product is reasonably safe for initial testing in humans.

Mitigation of bioreactor contamination risk is complex. People can be lulled into a sense of security that serum-free media eliminates that risk. However presence of contaminants such as mycoplasma can be devastating, leading to extensive investigation and downtime.

Sterile filtration is commonly employed for microbial removal and plays a pivotal role in assuring final product sterility.

In aseptic processing of pharmaceutical products, it is critical that drug products are free from bacteria and other microorganisms to ensure patient safety. Sterilizing-grade filters are commonly used to meet this requirement.

Regulations and regulatory guidance for the qualification and validation of sterile filtration processes are specific and well developed.