Single-Use Solutions and Quality Control
Adapted to Your Process and Application Cluster
The growing adoption of SUS in all process steps & applications of commercial production drives the need for more robust PAC based solutions and stronger Quality Assurance.
Single-Use Solutions Increasingly Used in More Critical Process Steps & Applications of Bio Manufacturing
The Challenges
Upstream Processing | Downstream Processing | Form | Fill & Finish |
|---|---|---|
| PAC 1 Media preparation Cell harvest | Buffer preparation Downstream Intermediates | Buffer preparation |
| PAC 2 Purification & Polishing of Drug Substance | PAC 3 Formulation & Filling of Drug Product |
PAC: Process step & Application Clusters
SUS Shifting from Clinical to Commercial Production Leads to More Stringent Requirements
Process & Application Clusters (PACs) | PAC1 Media, Buffer & Intermediates | PAC2 Drug Substances | PAC3 Drug Products |
|---|---|---|---|
Requirements Across all PACs | PAC based Pre Designed Solutions (PDS) & Quality Control Assurance of supply: quality assurance, change control & business continuity Industry-wide consensus standards | ||
PAC-specific Requirements | Biocompatibility Extractables (cell growth) | 100% closure integrity Particle (purity, reactivity) Simulated Leachables | 100% closure integrity Particle (safety, purity) Actual Leachables Lot Release Testing |
We Provide the Best Level of Process Monitoring & Quality Control
Our Solutions
Weekly monitoring on representative samples of our product families in our 4 manufacturing plants
- Bioburden
- Sub-visible particles
- Endotoxins
- Visible particles
We are strengthening our QC to provide
- Better control of visible particles
- Higher assurance of Container Closure Integrity (CCI)
- Lot release testing for critical products
Today QC Test
QC Test Frequency | SSB |
|---|---|
Bioburden | Weekly |
Endotoxin | |
Sub visible particles | |
Visible particles | |
Bag chamber leak test | 100% of 2D bag chambers |
With our PDS We Provide THE Certificate of Release that Meets YOUR Process & Application Requirement
Your Result
Weekly test on representative sample
100% test & inspection on bag chamber
| PDS with | PDS with | PDS with |
PAC 1 | |||
100% production test & inspection on finished products
| PAC 2 Certificate | ||
Laboratory test on finished product samples
| PAC 3 Certificate | ||
We Lead the SU Industry with our Level of Process Monitoring & Quality Control
Value Proposition
For Biomanufacturers who want to benefit of the advantages of SU to accelerate time to market, improve manufacturing efficiency and reduce costs
SSB provide the best level of process monitoring & Quality Control with a weekly control of bioburden, sub-visible particles & endotoxins
We are strengthening our Quality Assurance Levels with
- better control of visible particles
- higher assurance of Container Closure Integrity &
- lot release testing
to provide the Certificate of Release that meets your PAC requirements
