Bioprocess Bags For single-use bioprocess systems

Bioprocess Bags

For single-use bioprocess systems

Saint-Gobain is a leading global supplier of 50 mL to 3,000 L single-use bags for the biopharmaceutical industry. Our single-use bags are constructed of a multilayer film optimized for bioprocess production applications. The film materials are consistent throughout the product range, with LLDPE as the fluid contact material and EVOH as the gas barrier layer. All standard products are free of animal derived components.

Saint-Gobain은 바이오제약 산업을 위한 50 mL에서 3,000 L까지의 single-use bags의 선두적인 글로벌 공급업체입니다. 우리의 single-use bags는 바이오 공정 생산 응용 프로그램에 최적화된 다층 필름으로 구성되어 있습니다. 필름 재료는 제품 범위 전반에 걸쳐 일관되게 사용되며, LLDPE는 액체 접촉 재료로, EVOH는 가스 차단층 으로 사용됩니다. 모든 표준 제품은 동물 유래 성분이 포함되어 있지 않습니다.

Saint-Gobain BioProcess Systems are manufactured following cGMP that is QSR and ISO 9001 : 2015 compliant. Bags are manufactured and assembled at our Plymouth, MN facility that operates a certified ISO Class 7 cleanroom. Our standard designs are ready to fit a range of bioprocess functions, or we can deliver custom products to meet your exacting needs.

Saint-Gobain BioProcess Systems은 QSR 및 ISO 9001 : 2015를 준수하는 cGMP에 따라 제조됩니다. single-use bags는 ISO Class 7 클린룸 인증을 받은 Plymouth, MN 시설에서 제조 및 조립됩니다. 우리의 표준 디자인은 다양한 바이오 프로세스 기능에 적합하게 준비되어 있으며, 정확한 요구 사항을 충족시키기 위한 맞춤 제품을 제공할 수 있습니다.

Fluid Contact Layer - Linear Low Density Polyethylene (LLDPE)

Provides outstanding biocompatibility with broad chemical compatibility for safe handling of a wide range of biopharmaceutical liquids.

Gas Barrier Layer- Ethyl Vinyl Alcohol (EVOH)

Provides excellent barrier to the transmission of oxygen and carbon dioxide.

Strength Layer - Nylon

Provides outstanding impact and tear resistance, optimizing overall toughness of the bag.

Tie Structure

Multiple materials provide bonding between layers and add to overall

performance of the bag.

Film Thickness

Liners: 5 mil (side-wall) / 7 mil (bottom)

50 mL to 1 L bags: 7 mil ( = 177.8um)

2 L to 3000 L bags: 12 mil ( = 304.8um)

MATERIAL USED IN SAINT-GOBAIN BIOPROCESS BAGS

Saint-Gobain’s single-use, bioprocess bags are comprised of a 5-layer film (see Figure 2) optimized for bioprocess production applications. The layers of Saint-Gobain’s film, from the outermost to the product-contact layer, are as follows:

1. Nylon – providing impact and tear resistance for toughness while being handled.

2. Tie structure – multiple materials providing bonding between layers and add to the overall performance of the bag.

3. Ethyl Vinyl Alcohol (EVOH) – an excellent gas barrier against the transmission of oxygen and carbon dioxide.

4. Tie structure – another bonding layer.

5. Linear Low Density Polyethylene (LLDPE)

– product contact layer with broad chemical compatibility.

Through testing explained below, the materials and structure of Saint-Gobain’s bioprocess bags are proven to be extremely capable of ensuring that VHP does not permeate through to the bioprocessing fluid where it could contaminate and damage sensitive pharmaceutical products.

생고뱅의 Bioprocess Bag은 바이오제약 분야의 생산 어플리케이션에 최적화된 5겹 필름 구조로 구성되어 있습니다. 이 특별한 구조는 다양한 기능적 특성을 제공하며, 각 층은 특정 장점을 가져 사용자에게 안전하고 효과적인 바이오제약 액체 처리를 보장합니다.

1. 나일론 층: Bag의 전반적인 견고함을 최적화하며, 충격과 찢어짐에 대한 우수한 저항력을 제공합니다.
2. Tie 구조: 다양한 소재들이 층 간의 결합을 제공하며, Bag의 전반적인 성능을 향상시킵니다.
3. EVOH (Ethyl Vinyl Alcohol): 산소와 이산화탄소의 전송을 효과적으로 차단하는 우수한 가스 장벽 역할을 합니다.
4. Tie 구조: 층 간의 추가적인 결합력을 제공합니다.
5. LLDPE (Linear Low Density Polyethylene): 넓은 화학적 호환성을 가진 제품 접촉 층으로, 다양한 바이오제약 액체의 안전한 처리를 보장합니다.

Bag의 두께는 용량에 따라 달라집니다. 50 mL부터 1 L까지의 용량의 bag는 7 mil (약 177.8um)로, 2 L에서 3000 L까지는 12 mil (약 304.8um)입니다. 특히 이 Bag은 VHP가 바이오 처리 액체로 침투하여 민감한 제약 제품을 오염시키거나 손상시키지 않도록 매우 높은 성능을 보여줍니다.

Saint-Gobain의 Bioprocess Bag는 바이오제약 액체의 안전한 처리를 위한 최적의 선택입니다.

Vaporized Hydrogen Peroxide (VHP) is an increasingly common sterilizing agent in pharmaceutical manufacturing processes, particularly in final fill applications. For this reason, it is important that the single-use materials used in final fill processes are able to withstand exposure to VHP. Through rigorous testing, Saint-Gobain has demonstrated that their 5-layer, single-use bioprocess bags are well-suited for use in applications where VHP is employed for decontamination purposes.

제약 생산 공정에서, 특히 최종 충전 작업에서, 증기 상태의 과산화 수소 (VHP)는 점점 더 일반적인 살균제로 사용되고 있습니다. 따라서 최종 충전 공정에서 사용되는 일회용 재료가 VHP에 노출에도 견딜 수 있어야 합니다. 엄격한 테스트를 통해 Saint-Gobain은 그들의 5겹 일회용 바이오프로세스 백이 VHP를 사용하여 제균 목적으로 사용되는 어플리케이션에 적합하다는 것을 입증하였습니다.

CONCLUSION AND SUMMARY

With VHP so commonly used in final fill applications, it is important to select materials that are capable of withstanding exposure to and restricting permeation of hydrogen peroxide. Our testing successfully identified Saint-Gobain’s 5-layer film bioprocess bags as a suitable material for use in final fill applications with VHP exposure.

최종 충전 작업에서 VHP가 자주 사용되기 때문에, 과산화 수소의 노출과 침투를 견뎌낼 수 있는 재료를 선택하는 것이 중요합니다. 우리의 테스트를 통해 Saint-Gobain의 5겹 필름 바이오프로세스 백이 VHP 노출이 있는 최종 충전 작업에 적합한 재료임을 성공적으로 확인하였습니다.

Standard 2D Bags, 3 Ports, 50 mL to 20 L

6" Tubing Length, All Ports

Part #

Description

Tubing

Dimensions

Internal Surface

Port 1

Port 2

Port 3

Qty/

LxW in (cm)

Area in² (cm²)

Box

BP0050M

50 mL Bag,

Clear C-Flex® 374

5.22 x 3.85

26.00

1/4" x 7/16" x 6" (6.35 mm x

11.11 mm x

15.24 cm) MPC Insert, Port Cover, Pinch Clamp

1/4" x 7/16" x 6" (6.35 mm x

11.11 mm x

15.24 cm) MPC Insert, Port Cover, Pinch Clamp

1/8" x 1/4" x 6" (3.175 mm x 6.35 mm

x 15.24 cm)

LL Female + Needle- Free Sampling Port, Luer Cap, Pinch Clamp

STD 3 ports

(13.26 x 9.78)

(167.74)

BP0150M

150 mL Bag,

7.72 x 3.85

43.50

STD 3 ports

(19.61 x 9.78)

(280.64)

BP0250M

250 mL Bag,

9.72 x 3.85

57.00

STD 3 ports

(24.69 x 9.78)

(367.74)

BP0500M

500 mL Bag,

10.22 x 5.35

86.21

STD 3 ports

(25.96 x 13.59)

(556.13)

BP0001L

1 L Bag,

13.50x 6.48"

145.42

STD 3 ports

(34.29 x 16.46)

(935.48)

BP0002L

2 L Bag,

15.55 x 9.35

226.40

1/8" x 1/4" x 6" (3.175 mm x 6.35 mm

x 15.24 cm)

LL Female + Needle-Free Sampling Port, Luer Cap, Pinch Clamp

STD 3 ports

(39.37 x 23.75)

(1458.06)

BP0003L

3 L Bag,

18.05 x 9.35

271.40

STD 3 ports

(45.72 x 23.75)

(1748.38 cm)

BP0005L

5 L Bag,

18.34 x 12.35

364.52

3/8" x 5/8" x 6" (9.53 mm x

15.87 mm x

15.24 cm) MPC Insert, Port Cover,

Pinch Clamp

3/8" x 5/8" x 6" (9.53 mm x

15.87 mm x

15.24 cm) MPC Insert, Port Cover,

Pinch Clamp

STD 3 ports

(46.48 x 31.24)

(2348.38)

BP0010L

10 L Bag,

27.70 x 12.35

587.44

STD 3 ports

(70.36 x 31.24)

(3787.09)

BP0020L

20 L Bag,

28.12 x 18.35

887.98

STD 3 ports

(71.37 x 46.48)

(5722.57)

20" Tubing Length, All Ports

BP0050ML	50 mL Bag,	Clear C-Flex® 374	5.22 x 3.85	26.00	1/4" x 7/16" x 20" (6.35 mm x 11.11 mm x 50.80 cm) MPC Insert, Port Cover, Pinch Clamp	1/4" x 7/16" x 20" (6.35 mm x 11.11 mm x 50.80 cm) MPC Insert, Port Cover, Pinch Clamp	1/8" x 1/4" x 20" (3.175 mm x 6.35 mm x 50.80 cm) LL Female + Needle- Free Sampling Port, Luer Cap, Pinch Clamp	20
	STD 3 ports		(13.26 x 9.78)	(167.74)
BP0150ML	150 mL Bag,		7.72 x 3.85	43.50				20
	STD 3 ports		(19.61 x 9.78)	(280.64)
BP0250ML	250 mL Bag,		9.72 x 3.85	57.00				20
	STD 3 ports		(24.69 x 9.78)	(367.74)
BP0500ML	500 mL Bag,		10.22 x 5.35	86.21				20
	STD 3 ports		(25.96 x 13.59)	(556.13)
BP0001LL	1 L Bag,		13.50x 6.48"	145.42				20
	STD 3 ports		(34.29 x 16.46)	(935.48)
BP0002LL	2 L Bag,		15.55 x 9.35	226.40			1/8" x 1/4" x 20" (3.175 mm x 11.11 mm x 50.80 cm) LL Female + Needle- Free Sampling Port, Luer Cap, Pinch Clamp	20
	STD 3 ports		(39.37 x 23.75)	(1458.06)
BP0003LL	3 L Bag,		18.05 x 9.35	271.40				20
	STD 3 ports		(45.72 x 23.75)	(1748.38 cm)
BP0005LL	5 L Bag,		18.34 x 12.35	364.52	3/8" x 5/8" x 20" (9.53 mm x 15.87 mm x 50.80 cm) MPC Insert, Port Cover, Pinch Clamp	3/8" x 5/8" x 20" (9.53 mm x 15.87 mm x 50.80 cm) MPC Insert, Port Cover, Pinch Clamp		20
	STD 3 ports		(46.48 x 31.24)	(2348.38)
BP0010LL	10 L Bag,		27.70 x 12.35	587.44				10
	STD 3 ports		(70.36 x 31.24)	(3787.09)
BP0020LL	20 L Bag,		28.12 x 18.35	887.98				10
	STD 3 ports		(71.37 x 46.48)	(5722.57)

Standard 2D Bags, 2 Ports, 50 mL to 500 mL

Part #

Description

Tubing

Dimensions

Internal Surface

Port 1

Port 2

Qty/Box

LxW in (cm)

Area in² (cm²)

BP0050MS

50 mL Bag,

STD 2 ports

Clear C-Flex® 374

5.22 x 3.85

(13.26 x 9.78)

26.00

(167.74)

BP0150MS

150 mL Bag,

STD 2 ports

7.72 x 3.85

(19.61 x 9.78)

43.50

(280.64)

1/8" x 1/4" x 12" (30.48 cm)

Male Luer, Luer Cap, Pinch Clamp

1/8" x 1/4" x 12" (30.48 cm)

Female Luer, Needle-Free Site, Luer Thread Cover, Pinch Clamp

BP0250MS

250 mL Bag,

STD 2 ports

9.72 x 3.85

(24.69 x 9.78)

57.00

(367.74)

BP0500MS

500 mL Bag,

STD 2 ports

10.22 x 5.35 (25.96 x 13.59)

86.21

(556.13)

Standard 2D and 3D Bags for Tanks, 200 L to 500 L

Part # Description Dimensions LxWxH in (cm)

Tubing Port 1 & Port 2 Port 3 Port 4 Qty/Box

BP0200LB

200 L 3D Bag,

STD 4 ports

30 x 22 x 22

(76.2 x 55.88

x 55.88)

Clear C-Flex® 374

1/2" x 3/4" x 30" (12.70 mm x 19.05 mm

x 76.20 cm) MPX Insert, MPX Cap,

Pinch Clamp

1/8" x 1/4" x 30" (3.175 mm x 6.35 mm

x 76.20 cm) LL Female +

Needle-Free Sampling Port, Luer Cap, Pinch Clamp

1/2" x 3/4" x 30" (12.70 mm x 19.05 mm

x 76.20 cm) MPX Insert, MPX Cap,

Pinch Clamp

BP0500LB

500 L 3D Bag,

STD 4 ports

45.5 x 30 x 27 (11.56 x 76.2

x 68.58)

BP0050LP	50 L Bag, STD 2 ports	38.5 x 21.75 (97.79 x 55.25)			3/8" x 5/8" x 30" (9.52 mm x 15.87 mm x 76.20 cm) MPC Insert, Port Cover, Pinch Clamp	10
			Clear C-Flex® 374	3/8" x 5/8" x 30" (9.52 mm x 15.87 mm x 76.20 cm) MPC Insert, Port Cover, Pinch Clamp
BP0100LP	100 L Bag, STD 2 ports	45.5 x 29.5 (11.56 x 73.66)				10
BP0200LP	200 L Bag,	58.5 x 35				10
	STD 2 ports	(148.59 x 7.62)

Part #

Description

Dimensions

Tubing

Port 1

Port 2

Port 3

Qty/

LxWxH in (cm)

Box

50 L

11 x 11 x 27.5

Clear C-Flex® 374

1/2" x 3/4" x 30" (12.7 mm x 19.05 mm

x 76.20 cm) MPX Insert, MPX Cap,

Pinch Clamp

1/2" x 3/4" x 30" (12.7 mm x 19.05 mm

x 76.20 cm) MPX Insert, MPX Cap,

Pinch Clamp

1/8" x 1/4" x 30" (3.18 mm x 6.35 mm

x 76.20 cm)

LL Female + Needle-Free Sampling Port, Luer Cap, Pinch Clamp

BP0050LD

3D Bag,

STD 3 ports

(27.94 x 27.94

x 69.85)

100 L

15 x 15 x 30.5

BP0100LD

3D Bag,

STD 3 ports

(38.1 x 38.1

x 77.47 )

200 L

17.5 x 17.5 x 41

BP0200LD

3D Bag,

STD 3 ports

(44.45 x 44.45

x 104.14)

300 L

19 x 19 x 52.5

BP0300LD

3D Bag,

STD 3 ports

(48.26 x 48.26

x 133.35)

BP0500LD

500 L

3D Bag, STD 3 ports

39.25 x 39.25 x 42.25

(99.70 x 99.70

x 107.32)

Standard 3D Liners for Cylindrical Tanks, 20 L to 500 L

When Laid Flat in (cm) Fits Tank with ODxH in (cm) Qty/ Box

LR0020L

20 L Liner, STD 3D

21 x 19.5 x 15.25

(53.34 x 49.53 x 38.43)

11 x 15

(27.9 x 38.1)

LR0050L

50 L Liner, STD 3D

34 x 25 x 27.75

(86.36 x 63.5 x 70.18)

13 x 27

(33 x 68.6)

LR0100L

100 L Liner, STD 3D

36 x 32.5 x 30

(91.44 x 82.55 x 76)

18 x 30

(45.7 x 76.2)

LR0200L

200 L Liner, STD 3D

42 x 38.5 x 36.25

(106.68 x 97.79 x 91.77)

22 x 36

(55.9 x 91.4)

LR0300L

300 L Liner, STD 3D

54 x 41 x 48

(137.16 x 104.14 x 122.10)

24 x 48

(61 x 121.9)

LR0400L

400 L Liner, STD 3D

51 x 48 x 44.25

(129.54 x 121.92 x 112.40)

28 x 44

(71.1 x 111.8)

LR0500L

500 L Liner, STD 3D

68 x 54 x 49.5

(172.72 x 137.16 x 125.25)

31 x 49

(78.7 x 124.5)