OPUS® 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。
To support customer filings, the OPUS® Columns Regulatory Support File contains the following sections:
Configuration Options
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.
Certificate component | Manufacturing Pre-GMP OPUS® 5 - 80R |
Manufacturing GMP Run Ready OPUS® 5 - 80R |
---|---|---|
分析证书 | ♦ | ♦ |
Catalog number | ♦ | ♦ |
Lot number | ♦ | ♦ |
Serial number | ♦ | ♦ |
Actual column diameter | ♦ | ♦ |
Actual bed height | ♦ | ♦ |
Resin type | ♦ | ♦ |
Resin lot number | ♦ | ♦ |
Shipping/Storage buffer | ♦ | ♦ |
Packing date | ♦ | ♦ |
Asymmetry result | ♦ | ♦ |
Theoretical plate count (N/m) result | ♦ | ♦ |
TSO 9001 Compliance Statement | ♦ | ♦ |
Product Contact Materials Compliance Statement (animal-free, EMEA 410/01, USP Class VI) |
♦ | ♦ |
Copy of Resin Certificate of Analysis | ♦ | ♦ |
Packing environment | ♦ | ♦ |
QC chromatogram | ♦ | ♦ |
Chromatography resin control statement | ♦ | |
Resin sample for QC analysis | ♦ | |
Endotoxin test result <0.25 Eu/ml (pass/fail) | ♦ | |
Bioburden test result <10 CFU/ml (pass/fail) | ♦ |