「英中对照」Piramal Pharma在肯塔基州8500万美元扩建项目中启用内部无菌检测实验室

Piramal Pharma Solutions has opened a new microbiology laboratory at its sterile injectable manufacturing facility in Lexington, Kentucky, as part of an $85m expansion to increase commercial-scale production capabilities.Piramal Pharma Solutions 位于肯塔基州列克星敦的无菌注射剂生产基地新建了一座微生物实验室，这是其 8500 万美元扩建项目的一部分，旨在提升商业化规模生产能力。

The new facility more than triples the site’s existing microbiology testing space and is expected to reduce testing times by up to 50%, helping accelerate batch releases and reduce bottlenecks.新设施使该基地现有的微生物检测空间扩大至原来的三倍以上，预计可将检测时间缩短多达 50%，有助于加快批次放行并减少瓶颈。

Piramal Pharma Solutions is the contract development and manufacturing organisation (CDMO) business of Piramal Pharma, providing pharmaceutical development and manufacturing services across North America, Europe and Asia.Piramal Pharma Solutions 是 Piramal Pharma 旗下的合同开发与生产组织（CDMO）业务，在北美、欧洲和亚洲提供药物开发与生产服务。

The new laboratory includes a dedicated sterility testing suite with a Grade A isolator in a Grade C background environment, upgrading the site’s previous non-classified testing area.新实验室包括一个专用的无菌检测套间，配备置于 C 级背景环境中的 A 级隔离器，取代了该基地此前的非洁净级别检测区域。

The laboratory was released for routine Good Manufacturing Practice (GMP) use on 11 September 2026, with the sterility testing suite conditionally approved shortly afterwards.该实验室于 2026 年 9 月 11 日获准投入常规药品生产质量管理规范（GMP）使用，无菌检测套间随后不久获得有条件批准。

Grade A isolator doubles sterility testing capacityA 级隔离器使无菌检测能力翻倍

The dedicated sterility testing suite features a fully integrated Grade A isolator designed to support both open and closed filtration methods.该专用无菌检测套间配备一台完全集成的 A 级隔离器，可同时支持开放式和封闭式过滤方法。

The isolator doubles the site’s sterility testing capacity and allows multiple samples to be processed simultaneously, providing greater flexibility for different product testing requirements.该隔离器使基地的无菌检测能力翻倍，并可同时处理多个样品，为不同产品的检测需求提供了更大的灵活性。

Built-in pass-throughs enable samples to be transferred directly from manufacturing areas into the laboratory, reducing handling and the potential for contamination.内置传递窗使样品能够直接从生产区域传入实验室，减少了操作环节和潜在的污染风险。

The wider laboratory includes three new biosafety cabinets to support concurrent testing and reduce sample queue times. Incubators previously distributed across the site have also been consolidated within the laboratory to improve workflow, monitoring and accessibility.整个实验室还包括三台新的生物安全柜，以支持并行检测并缩短样品排队时间。此前分布在基地各处的培养箱也已集中整合至实验室内，以改善工作流程、监控和可及性。

The additional capacity is intended to support programmes progressing from clinical development to commercial manufacturing, while strengthening contamination control and sterility assurance.新增产能旨在支持从临床开发推进至商业化生产的项目，同时加强污染控制和无菌保障。

"The new microbiology laboratory represents an important milestone in our Lexington expansion journey," said Nathan Richardson, VP and Site Head, Piramal Pharma Solutions Lexington. "新微生物实验室是我们列克星敦扩建历程中的一个重要里程碑，" Piramal Pharma Solutions 列克星敦基地副总裁兼基地负责人 Nathan Richardson 表示。 

"By enhancing sterility testing and microbiological quality capabilities, we are further strengthening our ability to support clients with high quality, reliable, and responsive services throughout the product life cycle.”"通过提升无菌检测和微生物质量能力，我们进一步增强了在整个产品生命周期内为客户提供高质量、可靠且快速响应服务的能力。"

Full expansion due in late 2027整体扩建预计于 2027 年底完成

The laboratory is one of the first major components of the Lexington expansion to become operational. 该实验室是列克星敦扩建项目中首批投入运营的主要组成部分之一。 

The wider project includes an additional 24,000 sqft of manufacturing space and new equipment to support commercial-scale sterile injectable production.整个项目还包括新增 24,000 平方英尺的生产空间以及支持商业化规模无菌注射剂生产的新设备。

Planned additions include a new filling line, two commercial-scale lyophilisers, a capping machine and an external vial washer.计划新增的设备包括一条新的灌装线、两台商业化规模的冻干机、一台轧盖机和一台外壁洗瓶机。

The expansion is designed to increase annual production capacity from 104 batches to more than 240, according to the company’s original investment announcement.根据公司最初的投资公告，此次扩建旨在将年产能从 104 批提升至 240 批以上。

The full manufacturing expansion, including commercial-scale fill-and-finish operations, is expected to be operational in late 2027.包括商业化规模灌装和成品加工（fill-and-finish）业务在内的整体生产扩建预计将于 2027 年底投入运营。