Monitoring, Traceability & Quality Assurance

CCTV Monitoring

We maintain full CCTV integration across all critical facility infrastructure, including Grade A working zones, provides robust operational oversight, ensures data integrity, and supports strict regulatory compliance.

Microbiology Samples

ITH operates an exceptionally high-capacity infrastructure, processing over 8,000 microbiology samples weekly. To support this massive throughput, our facility utilizes large, dedicated walk-in incubators to manage a continuous rolling inventory of thousands of active culture plates.

Microbiology Samples

  • Refractometry is used to confirm the correct concentration of glucose solutions.
  • Enzyme indicators allow for room and raw material release based on real time results.

Microbiology Samples

  • Electrolyte levels are requalified on each container change using iCAP.
  • Facilities are monitored 24/7 for critical metrics such as pressure and temperature.

MALDI-TOF

MALDI-TOF is a gentle mass spectrometry technique used to analyse intact proteins, peptides, and microorganisms. It is widely applied in proteomics and clinical microbiology.

By integrating MALDI-TOF mass spectrometry into our high-capacity infrastructure, we rapidly process our weekly volume of over 8,000 microbiology samples, accelerating strain identification from days to minutes to ensure immediate operational insight and strict contamination control.

AMPiScreenTM ATP bioluminescence

To ensure rapid final product release, we complement our diagnostic workflow with the AMPiScreenTM ATP bioluminescence-based rapid microbiology system, which quickly screens for the presence or absence of bacteria, yeast, and mould contamination in our aseptically manufactured products.

AMPiScreenTM ATP bioluminescence

It delivers results up to 50% faster than standard ATP assays and 75% faster than traditional 14-day sterility tests.

AMPiScreenTM ATP bioluminescence

Core Benefits:
Faster Release: Cuts product quarantine times.
Inventory Savings: Reduces warehouse storage costs.
Compliance: Meets USP guidelines.
Versatility: Compatible with multiple product types-including viscous, pigmented, or solid materials.

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