Danish Dansensor CheckMate 4 residual oxygen headspace analyzer drug control nitrogen displacement process

In the field of drug production, nitrogen displacement process is an important link to ensure the stability and safety of drugs. By replacing the air inside the packaging with pure nitrogen, residual oxygen can be effectively reduced, preventing drug oxidation and degradation, and extending the shelf life. Insufficient replacement or sealing defects may cause oxygen infiltration, leading to drug failure and even the production of toxic metabolites. The Danish Dansensor CheckMate 4 desktop headspace gas analyzer, with its high-precision detection and intelligent analysis capabilities, has become the "quality controller" in the nitrogen replacement process for pharmaceuticals.Danish Dansensor CheckMate 4 residual oxygen headspace analyzer drug control nitrogen displacement process

CheckMate 4 adopts a dual system of zirconia sensor and infrared sensor for collaborative detection, with an oxygen resolution of 0.001% (≤ 10% concentration) and an accuracy better than ± 0.01% (≤ 1% concentration), which can accurately capture trace oxygen residues inside the packaging. In the freeze-drying process of penicillin bottles, this equipment can stably control the residual oxygen level below 0.5%, meeting the strict requirements of the Chinese Pharmacopoeia for nitrogen replacement of injections. A certain anti-tumor drug company found through CheckMate 4 testing that the oxygen concentration briefly increased during the 8th second of replacement on the production line. After investigation, it was found that the nitrogen supply was interrupted due to pressure fluctuations in the inflation pipeline. After adjusting the parameters, the replacement time of a single bottle was shortened by 20%, and the residual oxygen level remained stable and met the standard, avoiding batch quality risks.Danish Dansensor CheckMate 4 residual oxygen headspace analyzer drug control nitrogen displacement process

CheckMate 4 supports automatic storage of 1 million sets of data, which can be transmitted in real-time to the PC through USB interface or local area network, and can be used with optional software to achieve multi production line data monitoring and audit tracking. Its electronic audit tracking function complies with FDA 21 CFR Part 11 and EU GMP requirements, providing an immutable data link for drug regulatory audits. A vaccine manufacturer has integrated its equipment into an automated production line, achieving 100% traceability of packaging airtightness, meeting EU GMP standards, and reducing the risk of microbial contamination by over 90%.Danish Dansensor CheckMate 4 residual oxygen headspace analyzer drug control nitrogen displacement process

From dynamic process monitoring to local defect localization, and then to full process data traceability, CheckMate 4 has equipped the drug nitrogen replacement process with a "perspective eye" with its "real-time, accurate, and intelligent" detection capability, continuously driving the industry towards higher quality and efficiency.Danish Dansensor CheckMate 4 residual oxygen headspace analyzer drug control nitrogen displacement process

Denmark's Dansensor CheckMate 4 residual oxygen headspace analyzer drug control nitrogen displacement process, please call Yingxiao Instrument (Shanghai) Co., Ltd. Yingxiao Instrument (Shanghai) Co., Ltd. is the general agent, representative office, and after-sales service guarantee of the imported dew point meter brand Shaw SHAW from the UK.