OPUS® 5 - 80R Pre-packed Columns
For large-scale GMP manufacturing, OPUS® 5 - 80R Columns are packed in ISO 7 cleanrooms under a best in class ISO 9001 quality system.
Manufactured in ISO Class 7 clean rooms
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。
- Monitored weekly for viable and non-viable particles
- Monitored for viable contaminants during packing operations while dosing chromatography resin into the columns
- Restricted access area dedicated to the production of OPUS® columns only
- Routine cleaning and disinfection schedule
- Monitored room pressure differentials, 100% HEPA filtered air used to maintain air quality
- Required gowning procedures posted in all relevant areas
Complete Regulatory Support File
To support customer filings, the OPUS® Columns Regulatory Support File contains the following sections:
- Product specifications
- Manufacturing procedures
- Extractables and leachables
- Shipping qualification
- User instructions
- Material certificates
- Example Certificates of Analysis
- Product contact materials
Certificate of Analysis for each column configuration
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) | ♦ |