气流粉碎机GMP Demands

GMP Processing for Dry Powders and Ingredients

Expanded service offerings with our new ISO 8 classified processing suite for micronizing Pharmaceuticals, Nutraceuticals and Foodstuffs.

·       FDA Registered

·       ISO 9001:2015 Quality System

·       Self-Identified Generic API Manufacturer (GDUFA)

·       FSSC 22000 Certified

Various processing services are available such as micronization via spiral jet mills, hammer milling and screening at cGMP level protocols. It is capable of safely handling low-potent APIs, excipients and intermediates. Flexible isolation options allow for inert grinding and enhanced containment when necessary.

GMP Processing Facilities

ISO 8 (Class 100,000) classified area that features down draft ventilation, temperature & humidity controls, positive pressure airlocks, and an isolated gowning room.

Resources include Type III DI water for washdown and cleaning equipment, desiccant & HEPA filtered compressed air, carbon filtered & molecular sieve compressed nitrogen, and high purity (99.998%) liquid nitrogen for low temperature milling.

Has developed proprietary procedures for cryogenic milling in our ISO 8 area.  If you need to mill plastics pellets to < 1 mm for your small pharma extruder, while maintaining GMP conditions, we can help.

GMP materials are secured in our dedicated and environmentally controlled storage area.

干粉和配料的GMP加工

我们的气流粉碎机扩大了服务范围，新的ISO 8级别的加工处理适用于微粉化药品，营养药品和食品。

•Fda注册

•Iso9001:2015质量体系

•Self-Identified通用原料药生产商(GDUFA)

•Fssc 22000认证 

可提供各种加工服务，如通过螺旋射流磨粉，锤磨粉和cGMP级协议筛选。喷射气流粉碎机能够安全处理低效力原料药，辅料和中间体。灵活的隔离选项允许惰性研磨和必要时增强的密封。

GMP加工设施

ISO 8(100,000级)级别区域，具有向下通风，温度和湿度控制，正压气闸和隔离的更衣室。

资源包括用于冲洗和清洁设备的III型DI水，干燥剂和HEPA过滤的压缩空气，碳过滤和分子筛压缩氮，以及用于低温磨粉的高纯度(99.998%)液氮。

喷气流粉碎机已经开发了专有程序的低温铣削在我们的ISO 8级别区域。如果您需要为您的小型制药挤出机将塑料颗粒磨成小于1毫米，同时保持GMP条件，我们可以提供帮助。

GMP物料存放在我们的专用和环境控制的存储区域。