For those working in biological product manufacturing/aseptic process filling: you can greatly benefit from support by Franz Ziel GmbH (FZ) with many years’ experience in scientific testing/residual studies and skills we have acquired while working with other clients. We are happy to adapt our extensive services to special wishes. Imprint AP-brochure, date of issue: 2018-06

residual studies Vaporized Hydrogen Peroxide (vH2O2) used for bio-decontamination is a potential oxidative risk to sensitive biological products and may impact efficacy and stability. Less than 50 ng/ml (50 ppb) H2O2 residuals can cause significant protein oxidation. During project planning phases H2O2 residual studies via Amplex® Red assay (Limit of quantification 15 ppb) are used to define data based limits for H2O2 end point concentration, to ensure that the residual level is below level of impact for the product as it quantifies the level of H2O2 residuals absorbed by product containers/...

Conversion of Amplex® Red into Resorufin

All documents supporting the GCD are GMP and FDA compliant

Gassing cycle development - vH2O2 During gassing cycle development (GCD) the decontamination process of surfaces via vH2O2 is characterized and robust parameters are determined. The iterative GCD study steps result in a decontamination cycle with proven and confirmed cycle efficacy and security. We offer GCD as a standard service for all our enclosures with vH2O2 decontamination including all materials needed. This includes also the Factory testing GCD (FT-GCD) on FZ site. During FT-GCD and GCD the cycle is challenged with a microorganism known to be highly resistant to the effect of vH2O2 which...

Performance Qualification (PQ) Support vH2O2 cycles vH2O2 PQ support is provided by team members of the FZ Aseptic Processing Technologies department. It is used to qualify the developed cycle for being repeatable and robust, including the defined security margin. Typically triplicate BI challenges in three cycle runs are used to verify cycle efficacy and repeatability. We offer PQ support on request. This includes support in GMP/FDA compliant documents, the execution of one PQ cycle and training and supervision of the other two cycles to prepare operators and QA for Requalification (RQ). Materials...

Biological Indicator pre-use Qualification (BPQ) Biological Indicators (BIs) based on Geobacillus stearothermophilus are standard efficacy challenges for qualification of the vH2O2 bio-decontamination processes as they provide direct evidence of inactivation/kill. However, variances in the performance characteristics of BIs require careful analysis of each individual BI Lot. BIs can be subject to spore clumping in manufacture leading to false positive and variable efficacy because of BI quality issues. Also transport and storage conditions can influence the population and resistance of a BI Lot....

Smoke studies / CFD / LR According to the revised GMP Annex 1 Air flow patterns should be visualized in grade A/B areas. At the beginning of the project, the airflow can be visualized via CFD (Computational Fluid Dynamics) by our experts including the creation of detailed reports (demonstration, suggestions for improvement). Smoke studies using a smoke generator are performed to confirm unidirectional airflow everywhere inside the enclosure with defined acceptance criteria for airflow characteristics and velocity. They are also used to confirm the airflow along pressure cascades. By testing at...

The method for limitation of risk (LR-Method) provides reliable procedure for assessing potential microbiological risk of airborne contamination in clean zones in a systematic way. The LR-Method, which relies upon particle count analysis of particles in air movements, particle transfer testing and calculation of the Risk Factor presents an effective way for limitation of potential risks. It can be used for tracing the dispersion routes of airborne contamination risks, for identification of risk situations, for evaluating risks connected to single process steps, for immediate evaluation of changes,...

Environmental Monitoring (EM) Risk based environmental classification and monitoring are requirements from FDA and GMP Annex 1 and this topic is increasing due to the revision of the Annex 1. The program should include particle counts and microbiological monitoring. The EM concept has to be considered in the early project phase (Design review) to avoid space limitations that make efficient risk based concepts impossible. We provide support in Risk assessments for Environmental control and EM sample location positioning considering current best practice with the preparation of rationales for Environmental...

Active Air Head und Particle counter

Training Regulatory requirements on using Barrier Separation technology and the usage of those technologies are increasing in the last years. Our training program delivers the required understanding of aseptic production, Barrier Separation technology, contamination control and prepares for Filling line operational readiness with operator hands-on training. It also provides understanding Barrier technology maintenance under the scope of GMP/cGMP Compliance. This training addresses those employees involved in barrier technology projects; engineering, validation and operation of these systems.

 Expanding laboratory area

Assessing contamination control of pre-sterilised container tub transfers into an aseptic manufacturing filling isolator via a de-bagging/no-touch-transfer process step Ueogt LMWv*5i'. Bert Ratrmoiar**. Cornna Ma*r: ar-3 Am-Cainere Hocn’ 1 l.~l»)rw« ihnmwh a f«diutapr UMcrg Umam' 'A»e&f**x***w !*:**<*>$**turn Zitt&n+i Alwteak. Otane^ Through our participation in national and international standardization committees, non-profit societies and as speakers at different exhibitions and conferences, we keep a finger on the pulse and use our knowledge to develop the actual state of the art technology....