Enzyme Indicators: A Smarter Response to the Global BI Shortage

The Challenge: A Global Shortage of Biological Indicators

Across the pharmaceutical and life sciences industries, manufacturers and validation teams are facing a critical problem: a worldwide shortage of Biological Indicators (BIs). This shortage is causing delays, disrupting supply chains, and adding uncertainty to bio-decontamination validation processes.

If your manufacturing processes depend heavily on BIs, you’ve likely already felt the impact. Limited supply means longer lead times, increased costs, and increased uncertainty in validation planning.

The Solution: Enzyme Indicators

Enzyme Indicators (EIs) are a rapid and proven solution to reduce dependency on traditional Biological Indicators. They are a complementary diagnostic tool that can:

Reduce the number of BIs needed in your validation process
Lower dependency on BI supply chains, minimising risk from shortages
Deliver a quantitative data set with cycle efficacy insight within hours instead of days

This makes EIs a powerful tool for building a more robust, efficient, and resilient validation process.

While Biological Indicators remain important, the global shortage has made it clear: relying on BIs alone is no longer sustainable. Enzyme Indicators provide the flexibility and resilience modern manufacturing requires.

Discover how Enzyme Indicators can help you maintain compliance, protect your timelines, and secure your supply chain.

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Trusted by Global Leaders

80% of the top 20 Major pharmaceutical companies – including Pfizer, AstraZeneca, Roche, and Sanofi – are already integrating Enzyme Indicators into their validation workflows. These organisations are using EIs to safeguard against BI supply chain challenges while improving speed and reliability in their processes.

Latest Case Studies

Pfizer

How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation

Roche

Enzyme Indicators in Aseptic Production Environment

AstraZeneca

Champions Enzyme Indicators

Where can Enzyme Indicators be deployed?

EIs can be used in many applications where users need to validate the performance of bio-decontamination cycles. EIs are especially suitable where fast, accurate results are required.

Pharmaceuticals
Contract manufacturing
Original equipment manufacturing
Engineering
Hospital pharmacies
Universities/research organisations

Faster

Bio-decontamination results in 60 seconds

Smarter

Immediate Quantifiable Results

Safer

Increased or Enhanced Performance Assurance

Who are we?

Protak Scientific manufactures Enzyme Indicator technology (EIs), a rapid validation tool for gaseous bio-decontamination. EIs were originally developed in collaboration with Public Health England (now the UK Health Security Agency).

One of our largest sectors is Pharmaceutical Manufacturing, where we partner with over 80% of the largest global companies. 

We also provide validation consultancy to multiple sectors where bio-decontamination is critical to ensure safety and efficacy. Part of the technology is a specially developed software, ATHENA®, that delivers real-time quantifiable results for cycle efficacy. This offers enhanced reporting and review features that support compliance requirements.

The technology can help companies in various sectors design manufacturing facilities, build bespoke equipment or manage quality assurance of pharmaceutical production, providing customers with the most effective method of bio-decontamination validation.