IMA VPHP BioIndicator

Advanced Biological Indicators for VPHP Cycle Development & Qualification

IMA VPHP BioIndicator is the new generation of biological indicators designed by IMA Life specifically for VPHP bio-decontamination cycles used in isolators.

IMA VPHP BioIndicator supports Cycle Development, Performance Qualification (PQ), re-qualification and ongoing contamination control strategies, ensuring robust and defendable 6-log sporicidal performance. These biological indicators are based on Geobacillus stearothermophilus spores (ATCC 12980) and packaged in VPHP-permeable packaging.
Biological indicators are inoculated using a qualified manufacturing process and with a controlled spore population range suitable for validation up to a 6-log sporicidal reduction and each production lot is characterised by an independently tested system D-value, determined under representative VPHP exposure conditions.
A combination of controlled population range and verified D-value ensures consistent, reproducible and defendable biological challenge performance across all qualified lots.

Key Features of IMA VPHP BioIndicator

Controlled Spore Population & Distribution
Ideal for Cycle Development & PQ
Reduced Risk of Unexpected Positives

IMA Life – Microbiological Support Services

IMA Life, through its in-house laboratory, the IsoTech Lab, and a network of qualified external facilities, offers a comprehensive portfolio of services supporting commissioning, qualification, and experimental verification activities related to the most critical microbiological aspects of Isolation Technology.

The services are structured into three main areas:
• Services supporting quality assurance and batch validation of biological indicators, ensuring compliance, reliability, and repeatability of results.
• Experimental services aimed at optimising and improving aseptic and decontamination processes, performed at the IsoTech Lab using a scientific, performance-driven approach.
• Services supporting on-site qualification and requalification activities, carried out directly at the customer’s facilities.

All services are performed by highly qualified specialists in sterility assurance and applied microbiology for isolation technology. Activities are carried out in compliance with GLP principles and in accordance with relevant international regulatory guidelines, including EU GMP requirements for laboratory controls and FDA cGMP regulations for finished pharmaceutical products.