WELCOME!
SANDRA MEDLIN
SANI-TECH WEST
FLUID HANDLING
It’s not where the puck is, it’s where the
puck is going to be.
Wayne Gretzky
SaniSure, Inc. & Sani-Tech West
2 Distinctly Separate, Stand-Alone Businesses
Sani-Tech
West
SaniSure, Inc.
OEM
Buyer
Integrator
Assembler
Reseller
Component
Manufacturer
Stocking Distributor
& Warehouse
End Users
Who is SaniSure, Inc.?
• Founded in 2008, an
OEM, CGMP single use
system provider and
component manufacturer
focused on engineered
solutions….from concept
to prototype to
production.
What is SaniSure’s Goal?
Partner through the 6 stages of a solution provided
system.
– Design
– Develop
– Optimize
– Manufacture
– Assemble
– Sterilize
With strong emphasis on the 1st 3 cycles, focusing on
being ONE RESOURCE customers can go to for their
UNIQUE single use design needs.
FLUID HANDLING - TRADITIONAL OR SUS?
Some basic questions can help you begin to evaluate the
role that SUS can play in your operations
WHERE DO I START?
• How can you integrate SUS into existing clean-in-place
(CIP) for your operations?
• Are you trying to convert a legacy drug or a new drug or
vaccine in development? Because that will be a
different “look” in implementation.
• What are your needs regarding scalability? What are
your options for SUS implementation?
• Do you fully understand your application and what your
product is going to be?
THE BUSINESS QUESTIONS
• How do you ensure business continuity
— managing risks both upstream and
downstream — during the potential
change?
• What factors influence your “make or
buy” decision?
• How Do You Identify, Evaluate, and
Validate Vendors for SUS?
Economic Advantages of SingleUse
• Eliminate cleaning requirements
88.4%
Saving in cleaning costs
• Decrease risk of cross-contamination
82.5%
Reduce leak incidents
• Reduce time to get facility up & running
79.2%
• Reduce capital investment in
facility & equipment
77.8%
BioProcess International
Challenges of Implementation
in Production
•
•
•
•
•
•
No Experience
Concerns About Validation
Extractables/Leachables
Environmental Concerns
Concerns About Integrity
Animal Origins
Who is the BPSA?
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an
industry-led corporate member trade association dedicated to
encouraging and accelerating the adoption of single use manufacturing
technologies used in the production of biopharmaceuticals and
vaccines. BPSA facilitates education, sharing of best practices,
development of consensus guides and business-to-business
networking opportunities among its member company employees.
How will Sani-tech West & SaniSure
meet your fluid handling needs?
• Extensive Knowledge of systems and solutions
• Willingness to build smaller quantities keeping focused,
competitive pricing
• Lead Time Reduction
• Multiple Supplied Products Able to integrate products from a
number of component suppliers Filters, tubing, fittings, connectors, etc.
• Not owned by any one “OEM” Type Supplier
• Able to focus on your specific processes - Not Locked into a turn
key system
SaniSure™ Single Use Systems
THANK YOU FOR COMING!