TBL Media Botles, v.2.1

TM

Performance Plastics

A Q-BioPharma Company

CellgynÂŽ Media Bottles Ensuring Seal Integrity with Over-Molded Fluidics

tblplastics.com

Product Specifications

TBL Performance Plastics

TBL offers Media Bottles in two fluidic path options to meet your unique requirement

TBL Performance Plastics is now part of the growing Q Biopharma family of businesses.

We develop and manufacture non-metallic single-use products targeted to bio-pharmaceutical manufacturing environments. Our novel products are used throughout the world in most major pharmaceutical companies’ clinical supply manufactures, CMO’s, drug development companies and related OEM’s. We offer industry leading expertise in developing non-metallic fluid transfer and storage products with a heavy focus on quality, regulatory compliance, and meeting the application specific needs of our clients.

Our four manufacturing capabilities include tubing, fittings, single-use assembly, and DVS certified plastic fabrication. With the integration of all four divisions, our customers benefit from faster delivery times, less supply chain risk, added variety, innovation, and ultimately lower costs.

TBL specializes in working with many non-metallic materials including silicone, Kynar© (PVDF), ADIF Polypropylene, TPE ‘s, TPV‘s, phthalate-free Vinyl, Hytrel©, Nylon, PTFE, FEP, PFA and many other engineering polymers. In addition, we offer gamma irradiation services, and often work with distributors and OEM’s to private label their concepts.

Manufacturing Environment

All manufacturing and packaging are performed in an ISO Class 7 clean room environment.

All stoppers are over-molded to be homogenous with our tubing using our exclusive molding process. connection to maintain a barrier, greatly reducing any potential for bio-egress.

Materials of Construction

Quality

• Bottles- PETG (Optically Clear) • Closure/ tube plugs- Polypropylene • T SERIES-Stopper/ Tubing Cellgyn ® TPE one- piece molded design • S SERIES -Stopper / Tubing Pharm-A-Clear LH Platinum Cured Silicone • Filter- .2um (absolute) 25MM, PVDF membrane for superior gamma stability • Tube Clamp- ABS for superior mechanical strength and gamma stability • Packaging- Double bagged in easy peal, dual laminate 3 MIL bags polyester/PE for superior shelf life

We certified in accordance to ISO 9001 International Quality Management Systems, where our where our quality system is regularly audited and evaluated for conformance and effectiveness.

Our entire team understands that quality is mission critical and we all strive for continuous improvement.

Reliability

In today’s business environment consistency of supply chain is major concern. Because TBL Performance Plastic has always prided itself on excellent customer service and great deliveries. Now part of the Q BioPharma family, we have an expanded portfolio of products and service and a wider footprint to efficiently serve our customers in both North America and the EU.

Regulatory

All materials pass USP Class VI <88>, non-cytotoxic, non-pyrogenic, and are certified Animal Derived Ingredient Free (ADCF).

Made in the US

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TBL Facility in Sparta, New Jersey

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yETG Square Media / Packaging Bottles

Quality Components Ensure Better Laboratory Results.

Our standard features set us apart from our competition!

C-Series Cellgyn TPE Stopper / Tube Set PETG Square Media / Packaging Bottles 0

One-piece molded stoppers to ensure barrier seal integrity

Cap Specification

SPETG02500202

SPETG05000202

SPETG10000202

20%

Transparent

Yes

Leakproof

Yes

Particle Free

Yes

Pyrogen Free

SPETG00600202

Cellgyn ® Brand TPE Tubing for excellent barrier properties, purity and universal weldability

Overhead Space

SPETG01250202

Bottle Specification

Catalog #

SPETG20000202

C- Series Cellgyn (TPE) Top works

SPETG20000204

C-Series Cellgyn TPE Stopper/ Tube Set

38-430

24-415

125 mL

60 mL

Yes

Non-Cytotoxic / Non- Hemolytic Molded Graduations for Reference Measurements

Yes Yes

Nuclease Free

Yes

Sterile to SAL 10⁻⁶ (Gamma Irradiation)

25 – 40 kGy

Temperature Range

-40°C to +65°C

Size

53B

38-430

38-430

38-430

Standard Color

White

Material

High-Density Polyethylene (HDPE)

25mm .2um absolute for superior gamma stability in a critical area

Bottle Size

2000 mL

1000 mL

500 mL

Tubing Specification

Stopper/Tubing Material

Cap Torque (mm)

Tube ID/OD/Wall Siphon Tube Length

250 mL

Cellgyn (TPE) 38 in lb.

(43 1cmkg) to 53 in lb. (60 1cm-kg) 1/4”ID x 7/16” OD X 3/16” wall 24”

12 in lb. (13.1cmkg) to 17 in lb.

(19 1cm-kg)

27 in lb. (31cm-kg) to 33 in lb. (38 1cm-kg)

1/8” ID x 1/4” OD x 1/16” wall 24”

24”

Vent /Gas Filter

24”

24”

24”

8”

0.2 um absolute 25MM, Hydrophobic, PVDF

Tube Clamp

ABS

Plug

Polypropylene (ADCF)

Case Packed in Double Outer Bags Forked Syphon tubing for maximum drainability

Packaging

ABS tube clamps offer the most mechanically secure and gamma stable choice

Number of Bottles per Tray Number of Trays per Case Total Number of Bottles per Case Case Dimensions (L x W x H inches) Case Dimensions (L x W x H cm) Case Gross Weight

C-Series are supplied standard with a polypropylene plug on outlet of siphon tube

4

6

12

20

30

24

40

2

2

2

3

4

5

12

24

40

90

96

200

14.5 x 10 x 22.5

15.25 x 11.75 x 19.5

15.25 x 12.25 x 15.5

15.25 x 11.75 x 19.5

13.5 x 9.25 x 19.5

13.5 x 9.25 x 19.5

37 x 26 x 57

39 x 30 x 50

39 x 31 x 39

39 x 30 x 50

34 x 24 x 50

34 x 24 x 50

16.3 lb / 7.4 kg

23.6 lb / 10.7 kg

32.1 lb / 14.6 kg

48 lb / 21.8 kg

38 lb / 17.2 kg

52.5 lb / 23.8 kg

Cellgyn® Brand TPE Tubing For excellent barrier properties, purity and universal weldability.

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Silicone Square Media / Packaging Bottles

Quality Components Ensure Better Laboratory Results.

Our standard features set us apart from our competition!

S-Series Silicone Stopper / Tube Set

Silicone Square Media / Packaging Bottles 0

20%

Transparent

Yes

Leakproof

Yes

Particle Free

Yes

Pyrogen Free

Yes

Non-Cytotoxic / Non- Hemolytic Molded Graduations for Reference Measurements

Cap Specification

38-430

24-415

Yes Yes

Nuclease Free

25mm .2um absolute for superior gamma stability in a critical area

SPETG00600202

SPETG02500202

SPETG05000202

SPETG10000202

Overhead Space

SPETG01250202

Bottle Specification

S- Series Silicone Stopper Top works

SPETG20000202

Catalog #

SPETG20000204

S-Series Silicone Stopper/ Tube Set

There are many companies manufacturing media bottle kits today. TBL sets itself apart by using over engineered components to ensure optimum hygienic conditions after you open the bag.

Ask one of our technical representatives how we set ourselves apart from the other.

Yes

Sterile to SAL 10⁻⁶ (Gamma Irradiation)

25 – 40 kGy

Temperature Range

-40°C to +65°C

Size

53B

38-430

38-430

38-430

Standard Color

White

Material

High-Density Polyethylene (HDPE)

Bottle Size

2000 mL

1000 mL

Tubing Specification

Stopper/Tubing Material

Forked Syphon tubing for maximum drainability

Cap Torque (mm)

Tube ID/OD/Wall Siphon Tube Length

500 mL

250 mL

125 mL

60 mL

Pharm-A-Clear LH (Platinum Cured Silicone)

38 in lb. (43 1cmkg) to 53 in lb.

(60 1cm-kg) 1/4” x 7/16” x 3/16” wall 24”

24”

12 in lb. (13.1cmkg) to 17 in lb.

(19 1cm-kg)

27 in lb. (31cm-kg) to 33 in lb. (38 1cm-kg)

1/8” ID x 1/4” OD x 1/16” wall 24”

Vent /Gas Filter

24”

24”

24”

8”

0.2 um absolute 25MM, Hydrophobic, PVDF

Tube Clamp

ABS

Siphon Connector

AQS17002 1/8” Genderless Connector

Case Packed in Double Outer Bags

Packaging

S-Series are supplied standard with a Colder CPC Genderless AseptiQuik S Connector (AQS17002) on outlet of siphon tube

Number of Bottles per Tray Number of Trays per Case Total Number of Bottles per Case Case Dimensions (L x W x H inches) Case Dimensions (L x W x H cm) Case Gross Weight

6

7

6

12

20

30

24

40

2

2

2

3

4

5

12

24

40

90

96

200

14.5 x 10 x 22.5

15.25 x 11.75 x 19.5

15.25 x 12.25 x 15.5

15.25 x 11.75 x 19.5

13.5 x 9.25 x 19.5

13.5 x 9.25 x 19.5

37 x 26 x 57

39 x 30 x 50

39 x 31 x 39

39 x 30 x 50

34 x 24 x 50

34 x 24 x 50

16.3 lb / 7.4 kg

23.6 lb / 10.7 kg

32.1 lb / 14.6 kg

48 lb / 21.8 kg

38 lb / 17.2 kg

52.5 lb / 23.8 kg

Custom Solutions

PET-mechanic structure / gas barrier

If your Project requires customization, TBL can help!

If your project that requires specific a design or configuration, we have the capabilities to provide a turnkey and customized solution to meet your needs.

PE- inert contact barrier

Customers commonly come to us with simple concept sketches, component specification or a functional description. Our design department can take your concept and provide a detailed proposal with approval drawings and a budget.

Dual Laminate Pouch with Easy-Tear Seal • • • •

No Sharps required to open package No particles Superior Oxygen Properties mean extended shelf life Improved Puncture Resistance

3-D Modeling

Pictured: Customized multi-port centrifuge tubes

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TBL offers a wide range of sizes to match your unique requirement.

The Cellgyn® branded media bottle program is offered with two fluidic path options to meet your unique requirement.

Choose from either TPE (Cellgyn) with a pugged siphon tube or If your tubing specification calls for silicone, we offer the option with our LH series platinum cured silicone tubing. The Silicone version is supplied standard with a CPC genderless acetic connector (AQS17002HT)

2000 ml

C Series Cellgyn® TPE Stopper/Tubing

CPETG2000-0202 PETG/2000 ml/53B/CELGYN (TPE)/ 2 – 1/8” ID X 1/4” OD

250 ml

CPETG2000-0204 PETG/2000 ml/53B/CELGYN (TPE) 1/8” ID X 1/4” OD (Vent) X 1/4” ID X 7/16” OD

C Series Cellgyn® TPE Stopper/Tubing CPETG0125-0202 PETG/250 ml/38-430/CELGYN (TPE)/ 2 – 1/8” ID X 1/4” OD

S Series Platinum Cured Stopper / Tubing SPETG2000-0202 PETG/2000 ml/53B/ Silicone / 2 - 1/8” ID X 1/4” OD

S Series Platinum Cured Stopper / Tubing

SPETG2000-0204 PETG/2000 ml/53B/ Silicone / 1/8” ID X 1/4” OD (Vent) 1/4” ID X 7/16” OD

SPETG0125-0202 PETG/250 ml/38-430/ Silicone/ 2 - 1/8” ID X 1/4” OD

1000 ml

125 ml

C Series Cellgyn® TPE Stopper/Tubing

C Series Cellgyn® TPE Stopper/Tubing

CPETG1000-0202 PETG/1000 ml/38-430/CELGYN (TPE)/ 2 – 1/8” ID X 1/4” OD

CPETG0125-0202 PETG/125 ml/38-430/CELGYN (TPE)/ 2 – 1/8” ID X 1/4” OD

S Series Platinum Cured Stopper / Tubing

S Series Platinum Cured Stopper / Tubing

SPETG0125-0202 PETG/125 ml/38-430/ Silicone/ 2 - 1/8” ID X 1/4” OD

SPETG2000-0202 PETG/2000 ml/53B/ Silicone / 2 - 1/8” ID X 1/4” OD

60 ml

500 ml

C Series Cellgyn® TPE Stopper/Tubing

C Series Cellgyn® TPE Stopper/Tubing

CPETG0060-0202 PETG/60 ml/24-415/CELGYN (TPE)/ 2 – 1/8” ID X 1/4” OD

CPETG0500-0202 PETG/500 ml/38-430/CELGYN (TPE)/ 2 – 1/8” ID X 1/4” OD

S Series Platinum Cured Stopper / Tubing

S Series Platinum Cured Stopper / Tubing SPETG0060-0202 PETG/60 ml/24-415/ Silicone/ 2 - 1/8” ID X 1/4” OD

SPETG0500-0202 PETG/500 ml/38-430/Silicone / 2 - 1/8” ID X 1/4” OD

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CellgynÂŽ Media Bottles Ensuring Seal Integrity with Over-Molded Fluidics

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TM

Performance Plastics 12

A Q-BioPharma Company