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E9SU871

NovaSeptum® GO Preloaded System with Bottle, 9-port

sterile; γ-irradiated

Synonym(s):

NovaSeptum® GO Bottle

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About This Item

UNSPSC Code:
41104105
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Quality Level

400

material

316 stainless steel cannula, PETG bottle (fluid contact layer), TPE tubing, polyester body, silicone septum (platinum-cured)

agency

according to ISO 11137 (sterilization), meets ISO 146441
146441, meets ISO 88 biological reactivity (all component materials)

sterility

sterile; γ-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

application(s)

cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pharma/biopharma processes
sterile sampling
viral therapy

storage temp.

room temp

Related Categories

General description

Device configuration: Single Unit Sampling - Pre-loaded system
The NovaSeptum® GO pre-loaded disposable magazine is available with various standard configurations using NovaSeptum® GO high purity bags, autoclavable bags, bottles, transfer tubes or accurate volume (AV) syringe units. Other configurations are available upon request. For an optimal aseptic solution, use the NovaSeptum® GO pre-loaded disposable magazine together with a 1.5" or 2" NovAseptic® connector and NovaSeptum® GO pre-loaded starter kit (5/9 shot stainless steel base). Ideal for sampling from aseptic and sterile processes, the NovaSeptum® GO sterile sampling system provides consistently representative samples, safely and securely.

Application

Endotoxin
Bioburden - Archiving

Packaging

E9SU871-80060 (9x60 ml bottles, 3 units per box)
E9SU871-80125 (9x125 ml bottles, 2 units per box)
E9SU871-80250 (9x250 ml bottles, 1 units per box)

Preparation Note

Units are integrity tested at regular intervals during manufacturing.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.

Other Notes

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: Cap

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

Regulatory Information

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Articles

Risk Mitigation Through Bioburden Control: Closed Sampling

Explore microbial control strategies in drug manufacturing: bioburden management, contamination prevention, and reliable closed sampling.

Regulatory Framework for Sampling in Drug Manufacturing

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Improve Product Quality and Process Control with Sampling Solutions for Pharma and Biopharma

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Bioprocess Sampling Systems: Find the Right Sampling Approach for Your Needs

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Related Content

Global Trade Item Number

SKUGTIN
E9SU871-8012504061841179030
E9SU871-8025004061841179047
E9SU871-8006004061841179023

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