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Cleanroom Technology 洁净室与高科技制造·· 4 小时前AI 评分42

「英中对照」Particle Measuring Systems 推出用于隔离器的 BioCapt Single-Use STS 无菌微生物监测器

Particle Measuring Systems launches sterile microbial monitor for isolators

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Particle Measuring Systems(PMS)推出 BioCapt Single-Use STS 无菌微生物监测器,无需额外消毒即可将活性空气监测耗材传入隔离器和限制性进入屏障系统(RABS)。

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Particle Measuring Systems (PMS), a global leader in contamination monitoring solutions, today announced the launch of the BioCapt® Single-Use STS Microbial Monitor, a sterile transfer solution that enables the introduction of viable air monitoring consumables into isolators and Restricted Access Barrier Systems (RABS) without requiring additional decontamination activities.

Built on the proven BioCapt® Single-Use Microbial Impactor platform, BioCapt® Single-Use STS (Safe Transfer Solution) combines sterile-ready microbial impactors with validated Getinge DPTE-BetaBag® transfer technology, enabling safe transfer through Rapid Transfer Ports (RTPs) while maintaining isolator integrity. Compared to traditional Petri dish-based monitoring, the BioCapt® Single-Use reduces handling, minimizes contamination risks, supports continuous monitoring, and eliminates cleaning and sterilization requirements.

BioCapt® Single-Use STS allows manufacturers to introduce additional monitoring consumables during production without interrupting operations or initiating additional decontamination cycles. The solution can work for up to four hours at 25 LPM, after validation, to support continuous active air monitoring, helping improve process coverage, manufacturing efficiency, and contamination control while supporting modern contamination control strategies and evolving regulatory expectations, including EU GMP Annex 1.

"Manufacturers are under increasing pressure to strengthen contamination control while maintaining productivity," said Giulia Artali, Global Product Line Manager Micro & Sterility at Particle Measuring Systems. "BioCapt® Single-Use STS gives teams greater flexibility within isolator environments, helping them adapt monitoring strategies as production needs change without adding complexity to their operations."

Designed for pharmaceutical, biotechnology, vaccine, and radiopharmaceutical manufacturing environments, BioCapt® Single-Use STS is supplied in a validated sterile transfer configuration and includes comprehensive validation documentation to support implementation and regulatory compliance.

来源:Cleanroom Technology 洁净室与高科技制造 · cleanroomtechnology.com