In addition to Enzyme Indicator technology, Protak offers expert consultancy services to organisations that require bio-decontamination validation. We provide guidance on what facilities, equipment and processes are required for your bio-decontamination needs, as well as support throughout the entire lifecycle, for businesses with a wide array of unique needs and requirements.
Compliance with Annex 1 requirements
Enzyme Indicator technology is a rapid new method for yielding instant and quantitative feedback on the efficacy of the bio-decontamination process.
The EU Annex 1 Good Manufacturing Process (GMP) updated requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
Aseptic manufacturing poses the highest risk, as the product is not terminally sterilised. The revision of Annex 1 includes a number of new aspects of aseptic manufacturing and focuses on the need to achieve good contamination controls.
Section 4.22 of Annex 1 specifies that “the bio-decontamination process of the interior should be automated, validated and controlled within defined cycle parameters and should include a sporicidal agent in a suitable form (e.g. gaseous or vaporised form). Gloves should be appropriately extended with fingers separated to ensure contact with the agent. Methods used (cleaning and sporicidal bio-decontamination) should render the interior surfaces and critical zone of the isolator free from viable micro-organisms”.
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.
End 2 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.
The 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 product’s adherence from the original specification through to customer requirements. Adherence is ensuring the product or service meets and maintains regulatory compliance.
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 assist in 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 the risks outlined.
Digital data and validation software
Athena® is our bespoke software solution, which delivers real-time, quantifiable results for cycle efficacy with FDA CFR part 11 compliance.
It’s used in tandem with Enzyme Indicators to provide advanced reporting capabilities and we support our clients throughout their entire journey with Athena®.
Protak will verify that the PR2A reader as well as Athena® has been appropriately delivered to your organisation via the use of comprehensive validation documentation covering installation, operational and performance qualification phases.
Protak is able to arrange training to support your employees with their new facility or equipment. To ensure lasting and efficient system operation, a solid starting knowledge base is paramount. Through practical exercises, in-person training and e-learning options, we’ll equip your people with everything they need to maintain your system at optimal levels.