Contract Development & Manufacturing Organisations (CMO & CDMO)
Rapid validation for bio-decontamination. Enzyme Indicators offer benefits in the following core pharmaceutical disciplines such as Technical (Sterility assurance), Quality Assurance, Engineering / Validation, Production, Research & Development, Medicinal product manufacture including cell and gene therapy, Biotherapeutics and Biosafety.
Advantages and benefits of using Enzyme Indicators for Bio-Decontamination
- Reduced production downtime
- Reduction in the need for quality investigations
- Improved setup & configuration of your bio-decontamination process
- Robust cycle optimisation and validation
- Improved Quality by Design (QbD)
- Shorter validation project execution
Increased Speed of Medicinal Product Changeover
Enzyme Indicators halve typical production facility changeover during the batch manufacture process while significantly reducing risk of cross-contamination between multiple products.
As Enzyme Indicators can be positioned in multiple and often critical locations they offer significant advantages where bio-decontamination is used in complex environments such as cleanrooms, isolators, Restrictive Access Barriers (RABs), transfer chambers and laboratories.
Cycle Efficacy Assurance
When multiple high-value products are handled, the risk of validation failures can lead to expensive and lengthy failure investigations – leading to lost production hours and potential batch rejection.
Enzyme Indicators eliminate the traditional ‘run to fail’ validation approach as data is provided instantly.
The quantifiable results enable optimisation of cycle design based on data.
Controllable Decontamination Performance Verification
With Enzyme Indicators bio-decontamination processes are assessed prior to production starting and product being committed which allows for re-processing if the decontamination were to fail. No product has to be destroyed due to failed decontamination cutting costs and waste.
Enzyme Indicators assure complete, controllable decontamination performance verification for all manufacturing processes. The product is not released without decontamination assurances, there are less product recalls and a full product manufacturing and decontamination history is available.
Proactive Prevention of Decontamination Failure
We’ve developed Athena 2.0 our bespoke software that delivers real-time, quantifiable results for cycle efficacy with FDA CFR part 21, part 11 compliance reporting during continued process verification.
Athena is used alongside Enzyme Indicators to deliver advanced reporting capability, enhanced audit and review features along with data archive facilities during validation cycles. It can act as an early warning system allowing proactive execution and planning to occur.
Verification using Enzyme Indicators can highlight a decline in decontamination performance before it reaches a critical set-point. Preventative maintenance can be carried out before risk to batch processing occurs and the product has to be destroyed.
Our Digital Technology provides Real-Time Data
Athena™, our bespoke software is used alongside Enzyme Indicators to deliver advanced reporting capability, enhanced audit and review features along with data archive facilities during validation cycles and the delivery of “challenge area” design specific reports that can be analysed against the facility design specification during handover testing and shared with your clients to inform future design modifications.