OPUS® GMP Manufacturing Process
对于大规模 GMP 生产,OPUS® 2.5 - 80R 层析柱在遵从同类最佳 ISO 9001 质量体系的ISO 7级洁净室内装填。
Manufactured in ISO class 7 clean rooms
OPUS 2.5 - 80R Columns are packed in controlled classified clean rooms which meet ISO Class 7 non-viable particulate (NVP) standards. Buffer preparation occurs in a room which meets ISO Class 8 NVP standards.
Repligen在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。
- 每周监测活性和无活性颗粒
- 在将层析填料添加到层析柱内时,装柱操作过程监测活性污染物
- 专用于OPUS® 层析柱生产的限制进入区域
- 例行清洁和消毒时间表
- 监控房间压差, 100% HEPA过滤空气,以维持空气质量
- 在所有相关区域张贴要求的更衣程序
Complete regulatory support file
To support customer filings, the OPUS Columns Regulatory Support File contains the following sections:
- 产品规格
- 生产程序
- 溶出性和析出性
- 出厂质量
- 用户指南
- 材料认证
- 分析证书示例
- 产品接触材料
Certificate of analysis for each column configuration
配置选项
In order to provide the most flexibility, OPUS Pre-packed Columns are available for non-GMP and GMP applications. In general, OPUS non-GMP and GMP Columns are identical except as noted in the table. Resin samples are not provided with OPUS non-GMP Columns. OPUS GMP Columns come with a resin sample for incoming resin identity testing at the end-user's facility.
证书内容 | Manufacturing Pre-GMP OPUS 2.5 - 80R |
Manufacturing GMP Run Ready OPUS 2.5 - 80R |
---|---|---|
分析证书 | ♦ | ♦ |
产品编号 | ♦ | ♦ |
批号 | ♦ | ♦ |
序列号 | ♦ | ♦ |
实际层析柱直径 | ♦ | ♦ |
实际柱床高度 | ♦ | ♦ |
填料类型 | ♦ | ♦ |
填料批号 | ♦ | ♦ |
运输/储存缓冲液 | ♦ | ♦ |
装柱日期 | ♦ | ♦ |
不对称性结果 | ♦ | ♦ |
理论塔板数(N/m)结果 | ♦ | ♦ |
ISO 9001 合规声明 | ♦ | ♦ |
产品接触材料合规声明 (无动物源性、EMEA 410 / 01 、USP VI级) |
♦ | ♦ |
填料分析证书复印件 | ♦ | ♦ |
装柱环境 | ♦ | ♦ |
QC色谱图 | ♦ | ♦ |
层析填料控制声明 | ♦ | |
用于QC分析的填料样品 | ♦ | |
内毒素检测结果 <0.25 Eu/ml (通过/失败) | ♦ | |
生物负荷检测结果< 10 CFU/ml(通过/失败) | ♦ |