唔…啊 手指 出去Reliable gases for strict regulatory standards
Pharmaceutical companies are subject to two main constraints: strict regulations and standards such as Good Manufacturing Practices (GMPs) and Pharmacopoeias, and intense global competition. For example, the rapid development of generic drugs contributes to worldwide pricing pressure.
Air Liquide excels in the delivery of safe and valuable gas solutions to meet the research and manufacturing demands of our pharmaceutical and biotechnology customers. We know that the need for patient safety means that this industry is highly regulated, resulting in strict quality assurance, mandatory traceability and a need for process control.
Serving the entire value chain of the pharmaceutical industry
Thanks to our understanding of international regulatory requirements, we address these complexities through the supply of reliable, high purity gas products and secure gas supply methods. With our advanced expertise in temperature control and blanketing/inerting applications we are able to serve the entire value chain of the pharmaceutical industry, including R&D laboratories, active pharmaceutical ingredients (APIs) producers and pharmaceutical companies.
Nexelia? for Reactor Cooling
Nexelia? for Reactor Cooling provides a best-in-class indirect cooling solution to achieve effective temperature control by circulating a heat-transfer fluid refrigerated with liquid nitrogen.
Some API manufacturing steps—such as exothermic or low-temperature chemical reactions (e.g. chiral synthesis)—require low or very low temperatures to ensure safety and proper operating conditions.
Although mechanical cooling units are frequently used for this purpose, liquid nitrogen offers a highly efficient alternative. It’s an eco-friendly and particularly well-suited cooling source when very low temperatures are required. And its highly available cooling power allows for safe control of exothermic reactions.
CRYO COOLING UNIT-ALSK thermo-regulates reactors and any secondary cooling loop, thanks to the circulation of a heat-transfer fluid refrigerated with liquid nitrogen. The type of heat-transfer fluid varies depending on the exact temperature requirements.
With over 100 units already installed, CRYO COOLING UNIT-ALSK唔…啊 手指 出去 offers a compact, lightweight, noise-free solution to meet the needs of our customers.
Our end-to-end services have enhanced our reputation as a reliable supplier to world-class pharmaceutical and biotechnology companies around the globe. Our dedicated range of pharmaceutical grade gases, PHARGALIS?唔…啊 手指 出去 meets the dual need for high performance and compliance with regulatory standards.
唔…啊 手指 出去Conceived and intended for the manufacture of Active Pharmaceutical Ingredients (APIs) and drug products, our gases are traceable and delivered with certificates of analysis and conformity.
PHARGALIS? gases comply with the three major pharmacopoeias
Produced and delivered according to the Good Manufacturing and Distribution Practices (GMPs and GDPs) for excipients (joint IPEC-PQG GMP and GDP Guides and EXCiPACT? Standard for pharmaceutical excipients*), PHARGALIS? products also comply with the three major pharmacopoeias: USP-NF, Ph. Eur. and JP.
PHARGALIS? 1 is widely used for inerting at various steps in the production and packaging processes. Above all, our solutions help to preserve the quality of active ingredients and drugs, allowing our customers to more easily eliminate oxidation and prevent microbiological contamination of their products.
In addition to our PHARGALIS? products, we have the capacity to provide integral solutions for related applications, such as reactor cooling, cell culture, temperature-controlled?logistics and cryopreservation.
* applies exclusively to countries having an EXCiPACT??certification
Research and quality control
Our customers involved in research, testing, and measurement can rely on our high level of expertise, which is on par with their own. They look for our teams to be proactive in anticipating their needs and developing innovative, smart solutions tailored to their research.
Air Liquide provides a large range of quality analytical gases that include pure gases and mixtures, plus the appropriate gas-handling equipment and services.?ALPHAGAZ? is our worldwide range of specialty mixtures and pure gases for analytical applications.