Pre-Designed Solutions

Simpler, Safer, Faster & Cheaper Supply Chains for SUS

The adoption of SUS in all process steps & applications of commercial production drives the need for reducing complexity, enhancing quality, improving assurance of supply and reducing leadtimes.

The Accelerated Adoption of SU in Commercial Production Calls for...

The Challenge

SUS adopted in clinicals with massive customization & proliferation of SKU’s* (*Stock Keeping Units)

  •     >5.000 components from 100’s of suppliers
  •     >20.000 SKU’s created in the last 20 years
  •     >70% of SKU’s are specific to one customer

SUS growing in all Process & Application Clusters (PACs) of commercial production.

Need to reduce complexity at suppliers & end-users to provide

  •     More robust quality
  •     Stronger assurance of supply and
  •     More cost effective supply chain

SUSCAGR 15-20
Storage & shipping> 15%
Mixing> 20%
Freezing> 30%
Tubes & connectors> 10%
Sampling> 20%
Filling (DDS)> 20%
BioPlan Associates, Inc.

Commercial single-use-based manufacturing, consumes much more equipment than at pre-commercial scales.

PDS Established by 60 Experts Reviewing 4.000 Designs from 20 Years of Experience in Designing SUS

Our Solutions

  •     >1.200 PDS created to meet all functional and quality requirements of all PACs

PDS performance & AOS based on the complete control of our process from the resins to the final product.
 
All outsourced components are:

  •     Covered by quality agreement => consistent quality
  •     Secured by long term supply contracts => change control & business continuity
  •     Available off-the-shelf => best delivery reliability
PDS Bags & ComponentsUSP <87> or USP<88> Class VIBioburden Endotoxin ParticlesTSE-BSE EMA/41001Biphenol A free REACHNotification time
Flexsafe®, Flexboy® & Celsius® bagsYesYesYesConform48 months
TuFlux® TubesYesYesYesConform24 months
Opta® connectorsYesYesYesConform24 months
Sartopore® filtersYesYesYesConform24 months
FittingsYesYesYesConform24 months
ConnectorsYesYesYesConform24 months

Digital Finder Help You Select the Right PDS For Your Process Steps & Applications in 3 Clicks

PDS Provide Best Quality, Change Control, Business Continuity, Delivery Performance & Cost

Your Results

PDS simplify your process design & provide best quality

  •     Digital finder help select a PDS in <5 min
  •     1.200 PDS qualified & QC tested for your PAC

PDS provide best change control & business continuity

  •     48 month change notification for bags
  •     24 month change notification for components

PDS reduce complexity, costs & leadtimes

  •     Reduce proliferation of your SKU’s
  •     Optimize your inventory and costs
  •     Less P|N’s & components on stock for best leadtimes

* currently 8 weeks | ** currently 12 weeks

PDS Offer Safer, Faster, Simpler & More Cost Effective Supply Chain for SUS

Value Proposition

For you to fully benefit of the advantages of our SUS, we provide PDS tailored, proven & quality controlled for each of your PACs.
With quality & supply contracts in place, we guaranty you the best level of quality, change control & business continuity.
 
Using our PDS help you speed up your process design and reduce your number of SKUs, your inventory management complexity and your costs.
 
PDS finally offer best lead times with 2 weeks for MTS and 6 weeks for MTO.

Standard Vs CustomAOSPAC based QCLead timeComplexity & CostsValidation data
PDS++++2–6 weeks++++
CTO++++6 weeks++
Custom Standard+++6–10 weeks++
Custom Specific+O10 weeksOO


Digital Tool Pre-Designed Solutions (PDS)

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