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 ProductionLeads 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 RequirementsBiocompatibility
Extractables
(cell growth)
100% closure integrity
Particle (purity, reactivity)
Simulated leachable
100% closure integrity
Particle (safety, purity)
Actual Leachables
Lot Release Testing


We Provide the Best Level of Process Monitoring & Quality Control for Our SUS

Our Solutions

Weekly monitoring on representative samples of our 6 product families in our 4 manufacturing plants

  • Bioburden
  • Sub-visible particles
  • Endotoxins 

We are strengthening our QC to provide

  • Better control of visible particles
  • Higher assurance of Container Closure Integrity (CCI)
  • Lot release testing

Today QC Test

QC Test Frequency

SSB
Bioburden

Weekly
Representative
Sample

Endotoxin

Sub visible particle

Bag 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

  • Bioburden
  • Endotoxin

 Sub-visible particle

  • Visible Particle

100% test & inspection on bag chamber

  • 2D Bag Leak Test
  • 3D Bag Leak Test
  • Visible Defect Inspection
PDS
with
PDS
with
PDS
​​​​​​​with

PAC 1
Certificate

100% production test & inspection on finished products

  • Supplier Integrity Test
  • Extended Visible Particle Inspection
PAC 2
​​​​​​​Certificate

Laboratory test on finished product samples

  • Lot Release Test (LRT)
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