Pharma Services for Liquid Pharmaceuticals
Syntegon Pharmalab in Crailsheim
Syntegon Technology in Crailsheim has a longstanding tradition in the pharmaceutical industry as a developer and producer of fill/finish equipment for sterile liquid and powder products.
In 2004 the PharmaLab was established to support investigations, studies and services in process technology, which meet the standards of the pharmaceutical industry in performance, environment and documentation.
Our team of scientists, engineers and lab technicians conducts physical, chemical and microbial testing and analysis based on Syntegon-specific standard operating procedures (SOP) or according to customer-specific ones.
These services are based on state-of-the-art equipment (e.g. two production size isolators), multiple spectroscopical and microscopical techniques, calibrated probes and a clean room lab (ISO grade 8). Syntegon in Crailsheim is a DQS-certified site of Syntegon Technology GmbH.
Our scope includes:
Lab-based tests to support qualification and validation of aseptic fill/finish
- Quality assurance of biological indicators with microbial identification, spore count and D-value determination
- Determination of cleaning efficacy for washers with riboflavine-, sodium chloride-, particle- and endotoxin-tests
- Measurement of depyrogenation results of heat tunnels with thermocouples and endotoxin tests
Fundamental research on bio-decontamination processes in barrier systems
- Material studies on resistance and inactivation efficacy in processes with vaporized or fogged hydrogen peroxide
- Cavity penetration studies
- Determination of residual peroxide in ppb levels applying wet chemical and spectroscopical methods
- Support in determination of product tolerance against residual airborne hydrogen peroxide levels
Services for sterile fill/finish operation in RABS and isolators
- Development of test parameters for glove integrity testing
- Cleaning of H2O2 gas generator evaporators
- Development of loading schemes for material transfer airlocks
- Simulations of bio-decontamination and WIP processes with real size equipment
Pharma Services for Solid Pharmaceuticals
Centers of expertise for your research and development
In our centers of expertise around the world, we provide the fundamentals for further development of your products. We offer ideal conditions to carry out test series for new products or to optimize individual aspects. An extensive inventory of analytical equipment ensures that you always obtain the latest results for monitoring the development process.
The data collected is used as a basis for developing formulations, optimizing processes and for scale-up transfers. On request, our experts can also accompany your entire design and development process and support you in your work, including troubleshooting. In this way we accelerate your research, enabling you to launch your products sooner.
- Shorten the time to market with faster development process (TQE)
- Highest operation efficiency through selection of the right excipients and processes
- Quality by Design through process understanding and knowledge transfer
Leading-edge facilities for optimal solutions
In our center of expertise in Schopfheim/Germany, all process steps are simply and conveniently run through: from the production of solid dosage forms to test series for new or further development of your products. The laboratory is equipped for all process steps – including mixing, granulating, drying, pressing and coating tablets and pellets and filling capsules.
Customer trials and rental machines
Using the extended capabilities of the Hüttlin Pharma Center we provide our customers hands on assistance at any step of its product life cycle state. These could be complete solutions as well as the improvement of special part aspects. Our customers appreciate the freedom to choose whether the trials are processed by Hüttlin pharmacists or by themselves using the entire infrastructure of the Hüttlin Pharma Center.
Our center in Knowsley/United Kingdom specializes in tableting, coating and running test series for tablets and coating processes. With the Xpress 100 and the Solidlab 1 and 2 Serie we are able to provide trials for a realistic solid production .
Waiblingen/Germany focuses on developing capsule filling and micro dosing. With the GKF 702 the production of small batches for research and development or clinical purposes considering realistic production conditions – as machine speed – is possible.
Globally, there are local laboratories available for you to carry out fundamental feasibility studies. The basic equipment from our centers of expertise in Germany and Great Britain is available in Hangzou/China to provide best service close to our customers.