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

我們的氣流粉碎機(jī)擴(kuò)大了服務(wù)范圍，新的ISO 8級(jí)別的加工處理適用于微粉化藥品，營(yíng)養(yǎng)藥品和食品。

?Fda注冊(cè)

?Iso9001:2015質(zhì)量體系

?Self-Identified通用原料藥生產(chǎn)商(GDUFA)

?Fssc 22000認(rèn)證 

可提供各種加工服務(wù)，如通過(guò)螺旋射流磨粉，錘磨粉和cGMP級(jí)協(xié)議篩選。噴射氣流粉碎機(jī)能夠安全處理低效力原料藥，輔料和中間體。靈活的隔離選項(xiàng)允許惰性研磨和必要時(shí)增強(qiáng)的密封。

GMP加工設(shè)施

ISO 8(100,000級(jí))級(jí)別區(qū)域，具有向下通風(fēng)，溫度和濕度控制，正壓氣閘和隔離的更衣室。

資源包括用于沖洗和清潔設(shè)備的III型DI水，干燥劑和HEPA過(guò)濾的壓縮空氣，碳過(guò)濾和分子篩壓縮氮，以及用于低溫磨粉的高純度(99.998%)液氮。

噴氣流粉碎機(jī)已經(jīng)開(kāi)發(fā)了專有程序的低溫銑削在我們的ISO 8級(jí)別區(qū)域。如果您需要為您的小型制藥擠出機(jī)將塑料顆粒磨成小于1毫米，同時(shí)保持GMP條件，我們可以提供幫助。

GMP物料存放在我們的專用和環(huán)境控制的存儲(chǔ)區(qū)域。