「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 (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.全球污染监测解决方案领导者 Particle Measuring Systems (PMS) 今日宣布推出 BioCapt^® Single-Use STS 微生物监测仪，这是一种无菌传递解决方案，可在无需额外去污操作的情况下，将浮游菌活性空气监测耗材引入隔离器和限制进出屏障系统 (RABS)。

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（安全传递解决方案）基于经过验证的 BioCapt^® Single-Use 微生物撞击器平台，将可直接用于无菌环境的微生物撞击器与经过验证的 Getinge DPTE-BetaBag^® 传递技术相结合，可在保持隔离器完整性的同时，通过快速传递端口 (RTP) 实现安全传递。与传统的基于培养皿的监测相比，BioCapt^® Single-Use 减少了操作处理，最大限度地降低了污染风险，支持连续监测，并省去了清洁和灭菌要求。

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.BioCapt^® Single-Use STS 使制造商能够在生产过程中引入额外的监测耗材，而无需中断操作或启动额外的去污循环。该解决方案经过验证后，可在 25 LPM 下连续工作长达四小时，以支持连续主动空气监测，帮助提高工艺覆盖率、生产效率和污染控制水平，同时支持现代污染控制策略和不断演变的法规要求，包括欧盟 GMP 附录 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."“制造商面临着越来越大的压力，需要在保持生产效率的同时加强污染控制，”Particle Measuring Systems 微生物与无菌全球产品线经理 Giulia Artali 表示。“BioCapt^® Single-Use STS 为团队在隔离器环境中提供了更大的灵活性，帮助他们根据生产需求的变化调整监测策略，而不会增加操作的复杂性。”

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.BioCapt^® Single-Use STS 专为制药、生物技术、疫苗和放射性药物生产环境设计，以经过验证的无菌传递配置供货，并附带全面的验证文档，以支持实施和法规合规。