An introduction to Protak Scientific and Enzyme Indicators
Protak Scientific manufacture ‘Enzyme Indicators’ – the unique, advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
In addition to Enzyme Indicator technology we provide expert consultancy services for organisations requiring bio-decontamination validation of facilities, equipment, processes – offering validation lifecycle support for a range of unique needs and requirements.
Meeting the challenges of Annex 1 with Innovation in Rapid H₂O₂ Validation.
Processes that utilise Hydrogen Peroxide (H₂O₂) for decontamination (e.g. Isolators, pass-through chambers, room decontamination, etc.) have relied on initial validation and periodic revalidation to check the efficacy of the process with traditional methods.
Enzyme Indicators and Annex 1
Enzyme Indicators (EIs) are an innovative rapid tool for providing instant and quantitative feedback, of H₂O₂ efficacy by providing real time quantifiable data when applied to cycle optimisation, qualification and trouble-shooting.
With the revision of EU guidelines for GMP manufacture of Sterile Medicinal product, Annex 1 now complete, learn how the EIs ability to aid, clarify and provide additional confidence in the process of bio decontamination leads to an increased confidence in Quality Assurance and compliance to requirements.
Recent updates to Annex 1 of the European Good Manufacturing Practice (GMP) for sterile products have indicated that organisations must have a Contamination Control Strategy (CCS) in place to assess the factors that could potentially be introduced into a facility that may affect the quality of the product as well as its assurance of control on the manufacturing of its product.
End to End Validation Lifecycle Testing
Our technical team are able to assist with your validation lifecycle testing process. We’ll deliver the necessary equipment documentation while providing support through validation development and continuation in use.
End to end (E2E) is a testing methodology that is used to ensure the asset behaves as it is intended to do so. It involves testing the workflow from beginning to end.
Validation lifecycle is an approach towards the product that identifies elements at the concept stage through to customer end use. It also involves a continuous feedback loop which confirms the products adherence from the original specification through to customer requirements. Adherence is ensuring the product or service meets and maintains regulatory compliance.
Planning and Design phase – Validation Documentation
Before introducing our advanced Enzyme Indicator validation tool into your bio-decontamination processes we’ll provide a detailed assessment to determine how we effectively deliver your business requirements – and those of your customers. This documentation will include the verification, validation and design activities that are required.
User Requirements Specification
Protak offers comprehensive technical support. We’ll produce a user requirements specification (URS) that covers all of the technical and functional aspects of your product or process and we’ll make sure that your URS matches your requirements. Sometimes, things change and there may be a need to provide a specialised unique solution.
An effective URS would include:
- Your objectives
- Detailed technical specifications
- Design data
- Validation process documentation
- Installation, operational and performance qualification
- Training details
Protak provide the technical support enabling your full User Requirements Specification to be drafted and approved before the review to establish whether the requirements match the specification or if there may be a need to provide a specialised bespoke solution. Our subject matter experts deliver a unique mapping procedure identifying and prioritising your requirements before preparing user requirements for review.
Functional Design Specification
We provide Functional Design Specifications (FDS) to ensure your project is clearly defined and includes requirements for standards, associated documentation and regulatory requirements as well as detail of any control involved. A completed FDS ensures that all departments are aware of what is to be delivered at the end of the project.
We’ll manage your required Design Qualification (DQ) to ensure verification that your proposed facility or equipment design is suitable for its intended purpose. This often includes vendor documentation such as user and operational manuals as this can aid the verification.
A gaseous decontaminant, such as Hydrogen Peroxide (H2O2), acts as a surface decontaminant and will not penetrate any occluded surfaces to achieve effective decontamination which is why our Enzyme Indicators offer significant advantages over traditional methods.
Our Enzyme Indicators provide 100% performance assurance and quantifiable results to ensure optimisation of cycle design for multiple surface types and challenge points simultaneously.
Enzyme Indicators reduce risk of routine cycle failures, eliminating false positives and providing safer bio-decontamination.
We’ll advise on how enclosures and chambers should be set up to ensure adequate distribution and space to allow surface contact decontamination and prevent any spaces where H2O2 cannot contact.
Impact of the decontamination cycle is analysed by several factors such as surface area of the items within the load configuration and its compatibility and permeability of H2O2 on the material used.
Our technical team will advise on the setting of loading configurations to ensure efficacy is reached and consistent results are obtained. If required, a cycle load configuration can be optimised to ensure effective decontamination is reached.
Our Real-Time Digital Data and Validation Software
Protak Athena™, our bespoke software delivers real-time quantifiable results for cycle efficacy with FDA CFR part 21, part 11 compliance reporting.
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.
Installation Qualification (IQ) verifies the asset has been properly delivered, installed and configured according to the manufacturer’s specification. IQ also checks for energy supply and environmental conditions are acceptable as well as verifying the documentation received and software included.
Operational Qualification (OQ) involves testing the installed asset and making sure it performs as intended to within its operational ranges and as listed by the manufacturer. All aspects of the asset are tested and appropriate documentation notes the operations and parameters tested for quality assurance.
Performance Qualification (PQ) aims to prove that the asset is working within its accepted range and consistently performs under real-time conditions. The asset will be tested against a detailed test plan and aims to generate reproducible results every single time.
Protak can arrange staff training to aid with your new facility or equipment installation.
Ensuring lasting and efficient system operation requires a solid starting knowledge base. Through practical exercises, in-person training and e-learning options, we equip you with the skills you need to run and maintain your system at optimal levels. Our technical team also supports you as needed after you have finished your training.
Our technical team can aid in the investigation of bio-decontamination challenges such as Biological Indicator failures, long cycle durations or load configuration set-up.
From as little as one Enzyme Indicator distribution cycle we can carry out contamination control analysis to aid in investigations and visualising potential causes of a problem.
Once identified, our team will provide a technical report summary of findings for review and assisting on setting Corrective Actions and Preventative Actions (CAPA).
We’re able to review technical risk assessments and provide feedback on areas to improve to ensure full coverage of risks outlined.
We use Failure Mode and Effects Analysis (FMEA) to prioritise potential defects based on their severity and impact. We map out your process from start to finish with then impact, frequency and detectability scored based on historical data provided on the facility and equipment.
An FMEA can be performed on an existing facility where the data is verified and also is beneficial to a new process in order to identify the gaps and improvements. Recommendations can also be made based on those identified.