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公司簡介
博力安特（上海）潔凈科技有限公司，位于國際化大都市上海嘉定區(qū)。公司主要為生物醫(yī)藥行業(yè)，提供潔凈服及附件清洗滅菌服務(wù)、潔凈室環(huán)境建立、GMP咨詢及驗證，以及醫(yī)藥耗材一站式解決方案。
Brilliant (Shanghai) Lustration Tech Co.,Ltd. is located in Jiading District of Shanghai, an international modern city. We are mainly engaged in providing Cleanroom garment or other cleanroom articles on schedule wash and sterilize service , Cleanroom environment established, GMP consulting and validation and one-stop consumable solutions for the pharmaceutical industry.
其中，潔凈服及附件清洗滅菌服務(wù)，按照歐盟GMP標(biāo)準(zhǔn)，聘請上海醫(yī)藥工業(yè)研究院，高標(biāo)準(zhǔn)設(shè)計2000㎡潔凈廠房，生產(chǎn)區(qū)域為C級背景+A級送風(fēng)保護，生產(chǎn)單元采用MES追溯系統(tǒng)，實現(xiàn)數(shù)據(jù)信息化管理，確保審計追蹤和數(shù)據(jù)完整性。
Among our service , Cleanroom garment or other cleanroom articles on schedule wash and sterilise service We hired the chief designer of Shanghai Pharmaceutical Industry Design and Research Institute to design and build 2000 m2 clean workshop which in accordance with EU GMP standard . The production environment of the workshop is grade C background and grade A unidirectional flow. The MES production traceability system is adopted to achieve data information management, and all operation data are traceable.
潔凈廠房機電安裝，由中國電子第四工程建設(shè)有限公司承接建設(shè)。硬件設(shè)施優(yōu)選行業(yè)一線品牌，包括BWE，Lapauw隔離式雙扉洗烘設(shè)備、YORK空調(diào)系統(tǒng)、Ingersoll Rand無油空壓機、AUSTAR純化水制備及分配系統(tǒng)、Tofflon，SHINVA蒸汽滅菌柜，致力打造一流硬件設(shè)施和軟件服務(wù)，專注cGMP法規(guī)符合性，成為生物醫(yī)藥行業(yè)優(yōu)秀服務(wù)引領(lǐng)者!
The mechanical and electrical facilities in the clean workshop are installed by the Fourth Construction Co., Ltd. of China Electronics System Engineering. The hardware are first-line brands in the industry, including Lapauw, BWE isolated double-leaf washing and drying equipment, York HVAC system, Ingersoll Rand oil-free air compressor, Austar PW preparation and distribution system, Tofflon, SHINVA Autoclave. We commits to creating first-class hardware facilities and software services, Focus on cGMP regulatory compliance, Becoming an outstanding service leader in the biopharmaceutical industry!
聯(lián)系我們
聯(lián)系人：李經(jīng)理
地 址：上海市嘉定區(qū)北和公路1339號一幢A區(qū)
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