Biopharmaceutical Services Literature
Process Validation and Equipment Qualification
Process Validation Document Links:
- Extractables and Leachables Validation Services
- Validation and Qualification of Disposable Assemblies in Bioproduction Processes
- Mobius® Validation Services
- Extractables and Leachables for Filters, Bags and Other Components
- When do you need to consider revalidating the performance of your sterilizing-grade filter?
- Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade (0.22 µm) Durapore® Filters
- Mycoplasma Retention Testing for 0.1 μm Sterilizing-Grade Filters
- Bacterial Retention Testing for Validation of Sterilizing-Grade Membrane or Quantification of Bioburden Reduction
- Overcoming Bacterial Retention and Capacity Issues in Adjuvant Filtration
- Techniques for Demonstrating Cleaning effectiveness of UF Membranes
- Particle Shedding Validation Services
- Chemical Compatibility, Evaluation and Qualification Services
- Active and Preservative Pharmaceutical Ingredient Binding Analysis
- Drug Product-Based Integrity Testing: Establishing a Product/Filter Test Minimum Value
- Steam Sterilization & Integrity Testing Procedures
- Principles of Steam-in-Place
- Viral Clearance Validation Services
- Virus Filtration Services for Biopharmaceutical Manufacturing
- Ensuring Compliance: Regulatory Guidance for Virus Clearance Validation
- NovaSeptum® Validation Services
Equipment Qualification and Maintenance Document Links:
- Consulting services for the implementation of single-use systems
- Implementation services for Mobius® FlexReady Solution with Smart Flexware® assemblies for chromatography and TFF
- Mobius® FlexReady Solution qualification protocol and services
- Mobius® Disposable Mixing System qualification protocol and services
- Integritest® 4 System qualification protocol and services
- Chromatography Column Packing Services
- QuikScale® 300 mm – 630 mm Columns qualification protocol and services
- QuikScale® 70 mm – 250 mm Columns qualification protocol and services
- Millistak+® Pod Filter qualification protocol and services
- Isopak® Chromatography Columns qualification protocol and services
- NovAseptic® Mixers qualification protocol and services
- Slurry Transfer Skid qualification protocol and services
Webinars:
- Risk Based Assessment of Extractable and Leachable Substances from Single-Use Systems
Presented by: Ross Acucena Regulatory Consultant,Merck - Implementation and Validation Considerations for a Virus Pre-Filter
Presented by: Navid Khan, Ph.D.
関連リソース
