Controlling 3 Key Technology Platforms

Design and Manufacturing of top-quality assemblies

Pharmatainer

Bottles & Caps

We are one of the leading manufacturers of 10ML to 20L bottles. PET is best gas barrier and PC is ideal for freezing and/or high temperatures.

Elastomer & Silicone

Tubing

Stocked tubing sizes with eleven formulations to meet your specific application. Our portfolio includes platinum-cured silicone, Cellgyn® (TPE), and Pharm-A-Line I (TPV).

Bio-Pharm

Fittings

Single-use Sanitary connectivity- aSURE® gendered connections, Bio-Ease® Clamps, aseptic instrument fittings. Sanitary Reducers, barbs, threaded, fusion, site tubes, over-molded hoses.

Watch out COVID-19! The vaccine will arrive safely.

Customized Fluid Management Solutions

Covid-19

and other drugs

As the world races to find a vaccine solution to the COVID-19 pandemic, we want to let our biopharmaceutical partners know that we are here to ensure the safest, strongest and cleanest solution for delivering this vital product to the people who need it most. We have a customer support system implemented to move from the planning stages through production in a timely manner. We are ready!

Pharmatainer Support Cycle Diagram
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Plan

  • Application Specific Consultancy
  • Conceptual Design
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Design

  • SolidWorks
  • AutoCAD
  • 3-D Printing
  • Fabrication
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Prototype

  • ~6 weeks to get first Prototype
  • Autoclave
  • Pressure Testing
  • Accelerated Aging
  • Various Characterization Tools
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Produce

  • High Quality Standards
  • 2 Assemby Sites: US & EU
  • Collaborative Demand Planning
  • Application Support

Believe the Unbelievable

Drop Test

10L PC PharmaTainer gamma irradiated bottles were filled to nominal volume and frozen to -80C for 2 days. The bottles were then dropped two times in a row onto a flat concrete surface from 1,100mm height. After the contents thawed, leak tests were performed on the sides, base and closure. All bottles passed the drop test with only minor scratches.

Get Test Report

Nothing

Stronger

No Seal
Leakage

PharmaTainer bottles are made with a precision, flash and burr free neck, eliminating the primary cause of seal failure. Our bottles passed a positive pressure test – freeze & thaw cycles ambient to -80C.

Filling &
Shipping Kit

Custom shipping solution with up to 5 bottle filling and sampling lines, a rack for the manifold and protective caps for freezing provides unrivaled secure delivery.

Secure & Reliable
Connections

Both over-molding sanitary TriClamps and aSURE Fittings, with their one-piece composite gasket design, lower the risk of contaminations and leakages.

Bottle Particle Load Comparison

Pharmatainer Bottle Graphic

PharmaTainer

< 1.7% Particles

USP788 limits

Injection stretch blow molding.

Next Best Competitor Bottle Graphic

Next-Best Competitor

20X more particles

than PharmaTainer

Extrusion blow molding.

Nothing

Cleaner

 
Quality
  • ISO 9001 2015 certified
  • ISO 14644 Class 7 clean rooms Bottle molding & capping in Class 5
  • Full traceability of serial numbers, batch records & expiration dates
  • Change notification procedure USP class VI 88 & 87, USP 661 USP 85, USP 788, USP 787, ISO 10993 06, 10, 11, FDA CFR 21 compliant
  • Animal ingredient-free components
Control Over
Product Contact Material

All bottles are manufactured from 100% virgin ACDF approved medical grade resins with existing DMF files. This provides lot-to-lot consistency and longtime change control. We also hold safety stocks for resins.

Extremely Low
Particle Load

Our injection blow molded bottles are perfectly formed – no cutting needed. They exceed USP788 limits with <1.7% particles. The next cleanest bottle has 20x more particles.

No Detectable
Endotoxins

Testing for our bottles is based on a validated assay method using a 5% rinse volume and detection limit of 0.001 EU/ml. It complies with current USP <85> and EP Bacterial Endotoxin Testing (BET) methodologies.

3 Layers of
Poly Packaging

Bottles are packaged In a Class 7 clean room for transfers. The innermost layer is vacuum sealed to provide assurance of sterility. The second bag is heat sealed and the third poly layer is taped closed.

Extractables &
Biocompatibility

With comprehensive testing underway in accordance with the newly published USP <665> guidance and more, our goal is to provide the industry’s leading extractables qualification package. The study is being performed by a fully-accredited, third-party laboratory, under the supervision of a leading consulting firm.

Learn More

Getting the Drug There

Safely

Our out of the box custom filling, freezing & shipping kits provide a plug and play solution for our customers. The kits can include a filling line, sampling and protection caps for tubing and vent filter protection during freezing. We also provide shipping systems with temperature tracking. Our unique box concept allows easy handling of complex manifolds.

Pharmatainer Protection Caps
PROTECTION CAPS

They protect tubing and vent filters during freezing and for shipment.

Pharmatainer Box Concept
BOX CONCEPT

Easy handing of even complex manifolds. Boxes come with filling line, bottle assembly and sampling.

Pharmatainer Shippgin System
SHIPPING SYSTEM

Our shipping boxes with temperature tracking sensors provide a reliable solution.

3i Group

Who We Are

Bioprocessing Platform

We have established a single-use bioprocessing platform with superior flexibility, cleanliness and cost advantages over stainless steel equipment to serve the biopharmaceutical sector. With the acquisitions of Cellon, Silicone Altimex ,TBL Performance Plastics, and now SaniSure, 3i is able to deliver flexible solutions, innovative products and faster turnaround times.

The newly established platform will offer industry leading products, such as the PharmaTainer bottles and carboy product line, aSURE fittings, Tri-Clamp™ ends, BioEase clamps, a wide range of tubing solutions such as Cellgyn plus cleanroom bioprocessing assembly capacity in North America and Europe for custom solutions.

These products support the research, development and commercial production of life saving therapies, accelerating production setup times and time to market with lower required capital investment.

Company Logos
Cellon Logo CELLON S.A
Locations
  • Europe
  • ZAE Robert Steichen
  • 16, rue Héierchen
  • L4940 Bascharage
  • Grand Duché du Luxembourg
  • US
  • 1020 Flynn Road
  • Camarillo, CA 93012
  • United States
Phone
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