sanisure pharmatainer 1

PHARMATAINER

TM

Nothing stronger. Nothing cleaner.

BUILDING THE BEST HOME A DRUG CAN GET.

sanisure.com

WHO WE ARE

SIMPLIFYING STERILE MANUFACTURING SaniSure® is a global leader in the design and manufacturing of singleuse systems and components for drug and vaccine manufacturing and other biotech applications. Our core manufacturing capabilities include injection molding, injection-stretch blow molding, cleanroom assembly, tubing extrusion, fabrication, and other proprietary technologies. We have a global footprint of 5 manufacturing sites worldwide to provide our customers with an unrivaled level of vertical integration and supply-chain security.

SaniSure® is simplifying single-use technologies for sterile manufacturing. single-use bioprocessing industry.

With the combination of Cellon, Silicone Altimex ,TBL Performance Plastics, and Sani-Tech West in to SaniSure®, our resources, capabilities, and ability to create value for our customers is greater than ever and is unmatched in the industry.

WHERE WE ARE

5 MANUFACTURING SITES WORLDWIDE Sparta, New Jersey

Nottingham, United Kingdom

• Cleanroom Assembly • Tubing Extrusion • Injection Molding • Fabrication

• Silicone Tubing Extrusion • Silicone Hose Braiding • Cleanroom Assembly • Injection Molding

Camarillo, CA (Headquarters)

Bascharage, Luxembourg

• Cleanroom Assembly • Injection Molding • Fabrication

• Injection Blow Molding • Injection Stretch Blow Molding •Cleanroom for Inspection & Packaging

Camarillo, CA • Cleanroom Assembly • Fabrication • Injection Molding • Global Distribution Center

Sanisure’s global network of manufacturing plants and administration means that your product is close at hand Lorem ipsum dolor sit amet, iusto nostro omittantur ad pri, quo no reque luptatum scribentur. Mel magna nostrud platonem ea. Id eum voluptaria omittantur,

BUILDING THE BEST HOME A DRUG CAN GET.

sanisure.com

PHARMATAINER

TM

NOTHING CLEANER BOTTLE PARTICLE LOAD COMPARISON

PharmaTainer

Next-Best Competitor

< 1.7% of the USP788 limits

20x more particles than PharmaTainer®

Injection blow molding.

Extrusion blow molding.

The benefits of Sanisure’s injection blow molding vs. traditional blow molding include Lorem ipsum dolor sit amet, iusto nostro omittantur ad pri, quo no reque luptatum scribentur. Mel magna nostrud platonem ea. Id eum voluptaria omittantur, eu his dicunt alterum definitiones. Ad reque animal dissentiunt qui, omittam blandit no pri, te unum mucius maiestatis mel. Ei cum clita vocent ancillae.

Extractables

Control Over Product Contact Material

Extremely Low Particle Load

We have partnered with a leading bioprocessing institute and several fully-accredited, third-party laboratories to provide one of the most extensive extractables pacakges in the industry today.

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

Our injection blow molded bottles are perfectly formed with no cutting needed. They improve on USP 788 limits with <1.7% particles per representative studies. The next cleanest bottle had 20x more particles.

No Detectable Endotoxins Optional endotoxin testing for our bottles is based on a validated assay method using a 5% rinse volume and detection limit of 0.001 EU/ml. The method complies with current USP <85> and EP Bacterial Endotoxin Testing (BET) methodologies.

3 Layers of Poly Packaging

Quality Assured

Bottles are packaged In an ISO 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.

• Bottle Molding/ Capping in ISO Class 5 • ISO 9001 2015 certified • Each bottle inlcudes serial number and expiration date • USP 787, ISO 10993 06, 10, 11, FDA CFR 21 compliant • Animal-Derived-ComponentFree (ADCF) components

BUILDING THE BEST HOME A DRUG CAN GET.

sanisure.com

PHARMATAINER

TM

GETTING THE DRUG THERE

NOTHING STRONGER

SAFETY & SECURITY 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.

No Seal Leakage

Filling & Shipping Kit

Secure & Reliable Connections

PharmaTainer™ bottles are made

Custom shipping solution with

Both over-molding sanitary

with a precision, flash and burr-free

up to 5 bottle filling and sampling

TriClamps and aSURE™ Fittings,

neck, eliminating the primary cause

lines, a rack for the manifold

with their one-piece composite

of seal failure. Our bottles passed

and protective caps for freezing

gasket design, lower the risk of

a positive pressure test – freeze &

provides unrivaled secure delivery.

contaminations and leakages

thaw cycles ambient to -80C.

PHARMATAINER

TM

STRENGTH

THE 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

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

Box Concept

Shipping System

Easy handing of even complex

Our shipping boxes with

manifolds. Boxes come with filling

temperature tracking sensors

line, bottle assembly and sampling.

provide a reliable solution.

tests were performed on the sides, base and closure. All bottles passed the drop test with only minor scratches.

BUILDING THE BEST HOME A DRUG CAN GET.

sanisure.com

PHARMATAINER

TM

BOTTLES & CAPS

COMBINING 4 KEY TECHNOLOGY PLATFORMS AN UNPARALLELED LEVEL OF VERTICAL INTEGRATION

PHARMATAINER

TM

Bottles and Caps

LOREM IPSUM

Mixing

ELASTOMER & SILICONE

NOVEL

Tubing

Fittings

We are one of the leading

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Stocked tubing sizes with eleven

Single-use Sanitary connectivity-

manufacturers of 10ML to 20L

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formulations to meet your specific

aSURE® gendered connections, Bio-

bottles. PET is best gas barrier and

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application. Our portfolio includes

Ease® Clamps, aseptic instrument

PC is ideal for freezing and/or high

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platinum cures silicone, Cellgyn®

fittings. Sanitary Reducers, barbs,

(TPE), and Pharm-A-Line I (TPV).

threaded, fusion, site tubes, over-

temperatures.

Pharma Components

Precision molded closures and necks have robust threads that provide secure engagement between cap and bottle.

Closures seal at two points – inside the neck and on the rim of the neck– to provide a leak-proof seal.

Leading in Traceability

Each container is printed with a unique serial number, lot number, expiration date and machine readable data matrix to provide unrivaled traceability through the production process at Cellon and during use at your facility.

Many Sizes in Stock

10ml, 125ml. 500ml, 1,2,5,10, 20, and 50 liter containers. High clarity for exceptional visibility of contents with easy-to-read printed black graduations, accurate to +/- 2%. 500ml, 1 and 2 liters have indented, ribbed handgrip.

molded hoses.

Standard Caps

For aseptic filling and venting operations we manufacture a range of 2, 3 and 4 port caps in polypropylene (autoclavable*/ irradiation stable). * For best results ported caps should be fitted lose on bottle during the autoclave cycle.

CAP2V8

Overmolded cap system that provides an added level of security due to the composite (one piece) cap design.

BUILDING THE BEST HOME A DRUG CAN GET.

Torque is Key

Contact us to receive the recommended torque values to be applied to ensure a seal between the bottle and closure in both non-freezing and freezing applications.

sanisure.com

P H A R M A TA I N E R ®

PHARMATAINER

PHARMATAINER

TM

TUBING

MIXING

Mixed4Sure Pronto An aseptic, closed mixing system for low shear to vigorous mixing. Compatible with 5,10, 20, or 50 liter carboys, the Mixed4Sure Pronto is a suspended, magnetically coupled mixing system which is driven by a common stir plate. It is essentially a stir bar, suspened inside the container.

TM

Platinum-Cured Silicone Tubing

Cellgyn® TPE Tubing

Molded Sanitary Ends

We stock a full range Cellgyn® TPE sizes.

For the cleanest and most secure sanitary

Our Pharma-Clear® silicone tubing has

Cellgyn® has been qualified to weld with a

connections available, consider our extensive

a trusted reputation as the premier

wide range of competitors, such as C-Flex®.

portfolio of over- molded sanitary hoses.

choice in the industry. We specialize in

We have invested heavily in regulatory

With inhouse tooling capabilities and an

critical pump and transfer tubing for bio-

testing to save you time and money in the

extensive library of tooling, we have the

Gamma Stable Stir Bars and other Custom Solutions

pharma processes. We also manufacture a

validation process. Contact us for more

expertise to meet your needs with industry-

complete line of braided silicone hose for

information.

leading quality and delivery times. Ask about

For applications where mal dissentiunt qui,

SaniSure® has developed a full range

higher pressure applications.

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of gamma-irradiation compatible stir

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bars for bioprocessing and several other

Mixed4Sure Bottom Mounted Mixer

our range of sizes and materials.

solutions for volumes of 50 liters or less.

Our unique stir-bar design outperforms the competition in terms of low particle generation.

BUILDING THE BEST HOME A DRUG CAN GET.

sanisure.com

PHARMATAINER

ADDITIONAL

TM

PHARMATAINER KITS

NOVEL FITTINGS

TM

Bottle Assemblies/Transfer Sets

Asure® Fittings (Patent Pending) Our aSURE® technology enables us to make sanitary fittings with a gasket built in. Ideal for applications where bioburden reduction and seal integrity are critical. No more misalignment + no need to touch the gasket after sterilization = lower risk.

Bio-Pharma nents We manufacture and stock a vast range of single-use fittings and Tri-Clamp adapters.

Vertical integration with in-house tool/die manufacturing and generations of molding experience results in enhanced flexibility and control of supply. As a world-class provider of stock and custom injection-molded components/connectors, let us strengthen your supply chain.

Bioreactor Assembly Kits One bioreactor. One run. One kit.

Bio-Ease+ Clamps Our patented Bio-Ease+ sanitary clamps are suitable for autoclave and gammairradiation sterilization. We stock an extensive inventory of sizes up to 4” TC. Please contact us to learn more about the strongest, most trusted non-metallic sanitary clamp on the market.

Customized Assembly Kits Whatever the application needs, we can consult and collaborate to develop the appropriately tailored custom assembly required. Each assembly is designed and manufactured to meet specific requirements in a three stage process.

BUILDING THE BEST HOME A DRUG CAN GET.

sanisure.com

Sterile Closures, Filling Bells, & Torque Adapters

SIZING CHARTS

Part Number

Description

Units/Carton

STANDARD OFFERINGS

2595-PC28

28mm Torque Adapter

1

2595-PC48

48mm Torque Adapter

1

Bulk Packed Bottles (Sterile)

2595-PC70

70mm Torque Adapter

1

3070C1-01

70mm Cap, HDPE, sterile, for PET carboy

150

Part Number

Description

Units/Carton

3070C2-01

70mm Cap, HDPE, sterile, for PC carboys

150

100125-05

125ml PET Bottle

6

PIP295-10

Filling Bell, PC, NS, 10 units

10

200125-05

125ml Polycarbonate Bottle

6

PIP530-10

Filling Bell, PharmaTainer PC Material, NS, 10 units

10

100500-05

500ml PET Bottle

2

200500-05

500ml Polycarbonate Bottle

2

101000-05

1L PET Bottle

2

201000-05

1L Polycarbonate Bottle

2

Individually Packed Bottles (Sterile)

102000-05

2L PET Bottle

2

Part Number

202000-05

2L Polycarbonate Bottle

2

Carboys (Sterile) Part Number

Description

Units/Carton

105000-01

5L PET Carboy

6

205000-01

5L Polycarbonate Carboy

6

110000-01

10L PET Carboy

2

210000-01

10L Polycarbonate Carboy

2

120000-01

20L PET Carboy

2

220000-01

20L Polycarbonate Carboy

2

Units/Carton

28mm Torque Adapter

1

100500-01

48mm Torque Adapter

1

101000-01

70mm Torque Adapter

1

102000-01

70mm Cap, HDPE, sterile, for PET carboy

150

200125-01

70mm Cap, HDPE, sterile, for PC carboys

150

200500-01

Filling Bell, PC, NS, 10 units

10

201000-01

Filling Bell, PharmaTainer PC Material, NS, 10 units

10

202000-01

2L Polycarbonate Bottle

2

CUSTOM SOLUTIONS

Stability Vials &Tubes Part Number

Description

100125-01

Description

Units/Carton

100S10-49

10mL PET Stability Vial

245

200S10-49

10mL Polycarbonate Stability Vial

245

Sanisure offers works with customers to design and fabricate custom solutions for any application.

BUILDING THE BEST HOME A DRUG CAN GET.

sanisure.com

PHARMATAINER

TM

Nothing stronger. Nothing cleaner.

Europe

ZAE Robert Steichen 16, rue Héierchen L4940 Bascharage Grand Duché du Luxembourg +352.26.33.731

US

1020 Flynn Road Camarillo, CA 93012 United States +1 317.657.4194

sanisure.com