Biological Indicators Vs Enzyme Indicators
Biological Indicators vs Enzyme Indicators at a glance
Time for results |
Data available |
Compliance |
Variation |
Source |
Biological Indicators |
---|
7 days |
Binary |
Traditional technology |
-50-300% |
Bacterial Spores |
Enzyme Indicators |
---|
60 seconds |
Quantitive values |
Emerging technology |
< 15% |
Enzymes |
Learn how Pfizer use Enzyme Indicators to speed up Biological Indicator validation
The differences between EIs and BIs
Enzyme Indicators (EIs) offer a range of advantages over traditional Biological Indicators (BIs). One of the major benefits is EIs’ ability to provide clear, quantifiable results in seconds rather than days. This means users can have full confidence in the effectiveness of their bio-decontamination processes, which in turn leads to improved efficiency and reduced costs for these critical activities.
Faster Results
Traditional BIs require a seven-day incubation period before they can provide a result as to whether a gaseous bio-decontamination process has failed. By contrast, EIs give answers in just 60 seconds, providing for reduced costs, immediate batch verification and reduced risk that products will have to be destroyed.
Detailed Insight
Because EIs offer detailed, quantifiable data as opposed to the binary pass/fail information BIs deliver, this allows users to create long-term statistical data on their activities. In turn, this can be used to identify areas for improvement through Protak’s bespoke Athena software.
Guaranteed Performance
The use of enzymes means there is a much lower chance of variations in validations that can impact results and give a misleading impression. With EIs, users can have full confidence in the process, regardless of challenge locations or surface types.
Learn more about Protak's work
Where can Enzyme Indicators be deployed?
Pharmaceuticals
Contract manufacturing
Original equipment manufacturing
Engineering
Hospital pharmacies
Universities/research organisations
Faster
Results in 60 seconds
Smarter
Detailed, quantifiable data
Safer
Who are we?
Protak Scientific is the sole provider of Enzyme Indicators for gaseous bio-decontamination validation. As well as manufacturing and supplying this technology to more than half of the world’s 20 largest pharmaceutical companies and medical equipment suppliers, we offer management and consultancy services to improve the validation of facilities, equipment and processes throughout the decontamination lifecycle.
Our bespoke Athena software delivers real-time quantifiable results for cycle efficacy, with advanced reporting capabilities and enhanced audit and review features that ensure all operations meet compliance requirements.
These services help companies design manufacturing facilities, build bespoke equipment or manage quality assurance of pharmaceutical production, providing clients with the most effective method of bio-decontamination validation for any clean room setting or sterile environment.