RIM Bio, Inc.
Company Presentation
2013
CONFIDENTIAL 2013 RIM Bio, Inc.
RIM Bio Mission Statement
Our goal is to be recognized by the Bio-Process
Industry as the Low Cost solution for high quality
Single-Use Containers.
CONFIDENTIAL 2013 RIM Bio, Inc.
RIM Bio History
RIM Bio is a privately held US company and
manufacturer of single-use Bio-Process Containers.
RIM Bio was formerly known as RIM Medical which
was established in 2004 as a contract manufacturer
of medical device disposables. The name change
to RIM Bio took place in 2009 in order to
concentrate exclusively on the Bio-Process industry.
Our single-use products are now qualified and used
at many of the largest companies in the
Pharmaceutical and BioTech industries.
CONFIDENTIAL 2013 RIM Bio, Inc.
RIM Bio Locations
• RIM Bio USA - Seattle, WA
– Administration
– Customer Service
– Warehouse
• RIM Bio China – Changzhou, Jiangsu Province
– Production Facility
– R&D
CONFIDENTIAL 2013 RIM Bio, Inc.
Changzhou
Changzhou City (Metro pop. 3.3 million),
Jiangsu Province
Approximately 100 miles northwest of
Shanghai, this city boasts a long-time
industrial heritage. It is one of ten key
cities for the electronics industry. The
related machinery industry in
Changzhou ranks first in Jiangsu
province, while the plastics industry
ranks second in China. The
surrounding area is home to 130
colleges and universities.
CONFIDENTIAL 2013 RIM Bio, Inc.
RIM Bio Production Facility
• The RIM Bio China manufacturing facility in Changzhou,
Jiangsu province, is a wholly owned US factory of RIM
Bio, Inc. USA.
• Our 23,000 sq. ft. facility serves exclusively as our
manufacturing center for the production of Single-Use
Bio-Process Containers.
• We utilize a class 10,000 clean room within this building
for all production activity.
• RIM Bio is GMP compliant and ISO 9001 certified.
CONFIDENTIAL 2013 RIM Bio, Inc.
Changzhou Manufacturing Facility
CONFIDENTIAL 2013 RIM Bio, Inc.
Validation Checklist
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USP<88> Class VI
USP<87> Cytotoxicity
USP<661> Leachable/extractable
Bioburden
LAL
Long Term Sterility, 24 month
Air Leak Testing
Long Term Shelf Life Test
Long Term Gamma Stability
Seal Strength
Horizontal Impact
Drop
CONFIDENTIAL 2013 RIM Bio, Inc.
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Quality Control
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Certified GMP facility, Q1 2013
In Progress
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ISO 9001:2008
Yes
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ISO Class 7 Clean Room
Yes
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FDA Device Master File
In Progress
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Supply Chain Backup:
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Resins
Yes
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Films
Yes
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Converters
Yes
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All products fully traceable
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All products 100% Leak Tested
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All products 100% Light Board Visually Inspected
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All Materials are Animal Derived Component Free (ADCF)
CONFIDENTIAL 2013 RIM Bio, Inc.
Quality Assurance
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RIM Bio production facility is FDA registered
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All drawings and product specifications are reviewed.
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All components and raw materials are inspected before use.
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All manufacturing and inspection standards are validated before production begins.
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All Bio-Process products and components are assembled in the clean room.
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All components have strict lot control and traceability.
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RIM Bio performs extensive component and product reliability testing in-house and
through certified third party laboratories.
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RIM Bio utilizes inspection and test methods to specific industry requirements.
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RIM Bio test methods include but are not limited to:
– Class VI Toxicity
– Cytotoxicity
– Particulate Control
– Mechanical Properties
– Water Vapor Transmission Rate
– Oxygen Transmission Rate
– LAL testing
CONFIDENTIAL 2013 RIM Bio, Inc.
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CONFIDENTIAL 2013 RIM Bio, Inc.
Single-Use Products
We offer a variety of bio-process containers suitable for
cell culture and media storage. All our NxFlex films have
undergone extensive durability testing, meet cytotoxicity
requirements, and are USP Class VI certified by Toxikon,
Boston, MA.
Our products include:
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2-D Bags (100 ml – 100L)
3-D Bags (50L – 1600L)
Bags for Rocking Platforms (10L, 20L, 22L, 50L)
Media & Transfer Bags
Multi-Bag Manifolds
Blood Collection Bags
Tube set assemblies
CONFIDENTIAL 2013 RIM Bio, Inc.
2-D Single Port Bag
EVA Contact Layer
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2D Three Ports Bag
EVA Contact Layer
CONFIDENTIAL 2013 RIM Bio, Inc.
2-D Three Ports Bag
PE Contact Layer
CONFIDENTIAL 2013 RIM Bio, Inc.
3-D Bag
1600L & Test Chamber
CONFIDENTIAL 2013 RIM Bio, Inc.
3-D 1600L Bag
Folded for Packaging
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Bags for Rocking Platforms
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Media Bags
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Multi-Bag Manifolds
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Blood Collection Bags
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Engineering
• Engineering capability in US and China
• Project Management in US and China
• Engineering experience and expertise:
– Review product designs for manufacturability.
– Process and equipment set-up.
– Our engineering team can help in the selection of
Films, Components, and Bag Designs for your
specific applications.
CONFIDENTIAL 2013 RIM Bio, Inc.
Manufacturing
• We utilize the following processes:
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Heat Impulse Sealing
Constant Temperature Sealing
RF Sealing
On Site Gamma Sterilization
Leak Testing
Mechanical and Integrity Testing
Long Term Cycling for Flex Cracking
CONFIDENTIAL 2013 RIM Bio, Inc.
CONFIDENTIAL 2013 RIM Bio, Inc.
CONFIDENTIAL 2013 RIM Bio, Inc.
CONFIDENTIAL 2013 RIM Bio, Inc.
CONFIDENTIAL 2013 RIM Bio, Inc.
CONFIDENTIAL 2013 RIM Bio, Inc.
CONFIDENTIAL 2013 RIM Bio, Inc.
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Cycle Testing Platforms for Rocker Bags
http://vimeo.com/30746318
CONFIDENTIAL 2013 RIM Bio, Inc.
Thank you!
Contact RIM Bio
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Request information
Request a drawing
Request a sample
Please contact:
Isabelle Knoke
PO Box 33595
Seattle, WA 98133
206-362-3992 office phone
206-691-8811 office fax
CONFIDENTIAL 2013 RIM Bio, Inc.