Cap2v8® meets Pharmatainer ™
The Best Home a Drug Can Get®
Our Cap2V8 top is now available with the world’s cleanest, strongest bottle. This is the best solution in the market for the most critical biopharma applications.
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BROCHURE
Pharmatainer ™
Nothing stronger. Nothing cleaner.
Because we control and manufacture the most critical components of bottle assemblies, there is no better solution for the filling, freezing, shipping & storing of biopharmaceutical products.
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Stock & Custom Solutions
Bottles and assemblies in stock!
We keep a comprehensive inventory of presterilized bottles and bottle assemblies, so we can act fast to service your needs.
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Nothing cleaner
The Best Home a Drug Can Get®
Because of our unique manufacturing process with injection-stretch-blow molding, class 5 cleanroom concepts and robotic handling, we produce the cleanest bottles in the world. ISO 9001:2015 CERTIFIED ● ISO CLASS 7 CLEANROOMS ● ISO 11137 STERILITY PROGRAM
Get PharmaTainer™ Test ReportNothing stronger
The Best Home a Drug Can Get®
Because of our design and manufacturing technology, we produce the strongest bottles in the world. There is no better solution for the filling, freezing, shipping & storing of biopharmaceutical products.
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Even Stronger
Cellon, Sanisure, Silicon Altimex, Sani-Tech West and TBL are now part of SaniSure® group
With this merger, SaniSure will be a stronger global leader in the bioprocessing industry. The new combined SANISURE group will deliver custom solutions, innovative products, and faster turnaround times that will ultimately benefit you, our partners.
4 Key Components
To Make the World's Best Bottle and 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.
Bottles
Learn MoreCaps
Learn MoreElastomer & 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.
Custom Fluid Management Solutions
Concept
- Application Specific Consultancy
- Conceptual Design
Design
- SolidWorks
- AutoCAD
- 3-D Printing
- Fabrication
Prototype
- Few weeks to get first Prototype
- Pressure Testing
- Accelerated Aging
- Various Characterization Tools
Produce
- High Quality Standards
- 4 Assembly 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 ReportNothing
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 positive pressure testing with freeze & thaw cycles from 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™
< 1.7% Particles
USP788 limits
Injection stretch blow molding.
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.
Who We Are
SaniSure
SaniSure is a global leader in simplifying single-use systems for sterile drug and vaccine manufacturing and other biotech applications. With the combination of industry-leading single-use technology (SUT) companies (Cellon, Silicone Altimex, TBL Performance Plastics, GL Engineering and Sani-Tech West) in to SaniSure, our resources, capabilities, and ability to create value for customers is greater than ever and unmatched in the industry.
Our core manufacturing capabilities include injection molding, injection-stretch blow molding, cleanroom assembly, tubing extrusion, fabrication, needle manufacturing, and other proprietary technologies. With a global footprint of 6 manufacturing sites, we provide an unrivaled level of vertical integration and supply- chain security. Our founding companies have been at the forefront of SUT innovation for decades and have supported many clients through all phases of drug and vaccine development and production.
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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