Pharma & Biotech
Pharmaceutical and biotechnological processes place high demands on stable gas quality, controlled process conditions and verifiable documentation. GASYCO supplies digital gas mixing and analysis systems for precise process gas control, continuous monitoring and flexible integration – from laboratory and pilot plants to the industrial production environment.
Defined gas mixtures for gassing, inerting, reactors and customer-specific process atmospheres are provided precisely and reproducibly and documented automatically.
The GAN monitors gas composition, oxygen and moisture continuously. Automatic calibration and data recording support verifiable and regulated processes.
Controlled gas processes for sensitive production environments
In pharma, biotechnology and life sciences, process gases can have a direct influence on product quality, process stability and reproducibility. GASYCO systems enable the precise mixing, analysis and monitoring of gases – matched to the application, interfaces, documentation needs and installation situation. They help operators to make critical gas parameters visible, automatically detect the smallest pressure or flow fluctuations in the supply and record quality-relevant data verifiably.
Individually definable alarm limits increase the safety of the overall process and make deviations manageable early. Applications for CO₂-based control of reactor processes, for example, have already been implemented. In addition, solutions are possible for inerting, gassing, moisture and oxygen monitoring and customer-specific process gas supply.
Developed for the requirements of regulated processes
In regulated production environments, it is not only technical function that counts, but also the transparency of the system. GASYCO systems can be designed to support GMP-oriented requirements for documentation, calibration, alarms, qualification and data availability.
Depending on the application, EU GMP / EudraLex Volume 4, Annex 11 for computerised systems, Annex 15 for qualification and validation, ICH Q9/Q10 for quality risk management and pharmaceutical quality systems and, for cleanroom applications, ISO 14644 may be relevant. Where 21 CFR Part 11 for electronic records and signatures plays a role in US-regulated applications, our systems can also be adapted to these requirements on a project basis.
Precise gas control for regulated production environments
Precise process gas control
Digital gas mixers enable stable and reproducible gas mixtures for applications such as gassing, inerting, reactor supply, test benches or customer-specific process atmospheres. Depending on the application, control can be based on different target parameters – for example pressure, flow, concentration or process-specific variables such as pH value.
Continuous analysis and monitoring
Gas composition, residual oxygen and residual or process moisture can be measured continuously, so that critical deviations do not first become visible through spot checks or downstream quality control. Oxygen and moisture in particular are often relevant disturbance variables in pharmaceutical applications, as they can promote oxidative or hydrolytic degradation processes.
Documentation and traceability
Measured values, process data, calibration information and alarm events are recorded automatically and prepared for quality assurance, internal evidence or audits.
Integration into regulated environments
The systems can be adapted, according to the project, to controllers, data exports, operating concepts, alarm logic and qualification requirements.
Hygienic version
For production areas, the systems can be built according to common principles of hygienic design – with easy-to-clean surfaces, a suitable housing and a construction adapted to the installation situation.
Automatic calibration and easy-to-maintain design
Calibration, data recording and system monitoring can take place automatically, depending on the version. At the same time, the devices are designed so that maintenance or calibration on site can be carried out with minimal intervention and only a brief interruption to the process.
Which regulations apply here.
From our projects we know that these standards and guidelines come up again and again in the industry – at acceptance, in audits or during qualification. Gasyco systems provide the measured values, calibration data and records you need as evidence.
The right questions. The right answers.
Do the systems support GMP requirements such as Annex 11?
The systems can be designed to support GMP-oriented requirements for documentation, calibration, alarms, qualification and data availability. Measured values, calibration information and alarm events are recorded automatically; for US-regulated applications we can also adapt the systems to 21 CFR Part 11 for each project.
Why measure oxygen and moisture continuously?
Both promote oxidative or hydrolytic degradation. The Gas Analyser GAN measures residual oxygen and residual moisture continuously – so deviations become visible immediately, not only in spot checks or downstream quality control.
What can the gas mixer control to?
Depending on the application, to pressure, flow, concentration or process-specific variables such as the pH value. CO₂-based control of reactor processes, for example, has already been implemented. For production areas, the systems are also available in hygienic design.
The devices from the system overview.
These devices are used.
Let’s talk about your system.
From design to commissioning – we plan your gas supply as a connected complete system.