– A main focus of Franz Ziel.
Aseptic processing in the pharmaceutical industry requires a sterile environment which can be realized by clean room technology including barrier systems such as like isolators and RABS. But there are many guidelines which make the work even more demanding and present a real challenge. The innovative portfolio of Franz Ziel meets this challenge in many ways.
Product safety with determination of residual concentration
Vaporized hydrogen peroxide (vH2O2) used for bio-decontamination is a potential oxidative risk for sensitive biological products. The residual level of H2O2 residuals absorbed by product/ containers can be quantified to ensure that the residual hydrogen peroxide concentration is below the level of impact for the product. You can leave it to Franz Ziel as in our analytical test lab we perform a very large range of tests, but our FZ laboratory experts can also assist you at your site.
Proving process efficacy with vH2O2 cycle development (GCD)
A safe decontamination cycle is ensured by means of cycle development, where the surface decontamination cycle with vH2O2 is characterized and stable parameters are developed. We offer this service for all our barrier systems with vH2O2 decontamination. But there is more to it – all barrier systems include our own bio-decontamination system (FZ-BDS 12/60), which enables for in-process control l of the decontamination cycle.
Support for Performance Qualification (PQ) of vH2O2 cycles
PQ is used to qualify the developed cycle for being repeatable and robust. PQ support by FZ staff includes assistance with the preparation of GMP- and FDA-compliant documents, performance of a PQ cycle and training and supervision during two further cycles.
Qualification of biological Indicators (BI)
It is recommended to check the quality of the BI used for GCD and PQ, as failure in quality lead to false positive results. FZ offers as part of the qualification the scanning electron microscopy, identification, determination of population and determination of system D-Value in accordance to DIN EN ISO 11138-1 and USP.
Robust from the inside – Smoke studies / CFD / LR
Smoke studies are performed in order to identify unidirectional airflow, using defined acceptance criteria for airflow characteristics and speed. These studies are able to confirm the robustness of the aseptic status. We offer this service for all our barrier systems in combination with complex filling machines.
Good training leads to success
With Franz Ziel, you can do more than position your products and machinery at the forefront of cleanroom technology. We also offer efficient training of your staff who are involved with set-up, validation and operation of barrier systems and associated projects, as quality is not only based on innovation, but also on service.