4 Key Components

To Make the World's Best Bottle and Assemblies


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


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).



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

Pharmatainer Support Cycle Diagram
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  • Application Specific Consultancy
  • Conceptual Design
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  • SolidWorks
  • AutoCAD
  • 3-D Printing
  • Fabrication
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  • Few weeks to get first Prototype
  • Pressure Testing
  • Accelerated Aging
  • Various Characterization Tools
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  • 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 Report



No Seal

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

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


< 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.



  • 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

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 &

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
Camarillo, CA, Cleanroom Assembly. Camarillo, CA, Headquarters, Cleanroom Assembly, Injection Molding, Fabrication, 3D Printing	, In-House Tool & Die. East Hanover, New Jersey, Needle Manufacturing, Cleanroom Assembly, In House Tool & Die. Sparta, New Jersey, Cleanroom Assembly, Injection Molding, Tubing Extrusion, Fabrication, In-House Tool & Die. Stapleford, UK, Tubing Extrusion, Cleanroom Assembly, LSR Injection Molding, HCR Injection Molding, HCR Compression Molding. Bascharage, Luxembourg, Injection-Stretch-Blow Molding, Injection Molding, ISO Class 5 (Molding), ISO Class 7 (Packaging).

Who We Are


SaniSure Logo

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.

  • Europe
  • ZAE Robert Steichen
  • 16, rue Héierchen
  • L4940 Bascharage
  • Grand Duché du Luxembourg
  • Americas
  • 1020 Flynn Road
  • Camarillo, CA 93012