®

NovaSeptum Sterile
Sampling System
Put your process
under control.

The life science business of Merck

operates as MilliporeSigma in the
U.S. and Canada.
The challenge
Speed and compliance are very important throughout the industry. There is
always a constant risk of contamination, not only threatening a process delay,
but also impacting the integrity of the sample and the physical safety of your
operators. Traditional sampling methods that require SIP between sampling
events add time and complexity to your process.

The solution
From media preparation to final formulation and fill, the NovaSeptum®
sampling system provides a comprehensive solution, enabling the collection
of representative samples where you need them, without cleaning, welding
or steaming between samples.
The ready-to-use system is both sterile and closed, as well as user
configurable, delivering outstanding quality and performance. With
flexible formats and volumes, our sampling solution gives you
versatility without liability. Our experts will work with you
to design and define a highly efficient sampling plan
that meets regulatory requirements, providing
you with everything required for
successful implementation.

NovaSeptum® system compared to other sampling methods

NovaSeptum® Other single use Traditional
systems sampling methods Sample valves Tube welding
Closed and pre-sterilized

User configurable
Ready to use/
Pre-assembled
Sample anywhere:
Ingold, In line and
custom holders
Representative sample:
No dead leg, flush or
sample dilution
Patented accurate
volume closed syringes
Single use system
compatible
Autoclavable N/A N/A
Implementation made easy

Certification for each lot Other tests *

Claim Conformity Test Post Sterilization
(Beta) 25-70 kGy VHP Tightness
Sterilization
(Gamma) 25-40 kGy Cytotoxicity USP <87>
Dose auditing:
Validation of Sterilization Bioburden Recovery
SAL 10-6 - ISO 11137‑
Endotoxin Recovery
USP <88> for
Biological Reactivity Tests Extractable USP <661>
Class VI plastics
< 2.15EU/device - Integrity Test on Crimped Tubes
Bacterial Endotoxin Test
USP <85> Sterility Testing
0.50 bar (7,25 psi) at Crimped Tubing Pull Test
25°C (77°F): 50-100-
250ml High Purity bags, Burst Test
Bottles, single and Low Temperature Storage Test
Manifold Syringes High Temperature Storage Test
Test Pressure
0.30 bar (4,35 psi) at Transportation Test
25°C (77°F) : 1L High * Applicability may vary
Purity bags, Manifolds
and Autoclavable units
From 2 to 3 years,
Shelf Life depending on the
disposable unit
Clean Room for Assembly ISO®8 - ISO® 14644-1
 Your sampling plan, our solution

Sampling requirements

Pick your
connector
TC Ingold® In-line Custom Single-use

Pick your
sampling
module:
Single or Syringe Bottle HP Bag / Autoclave Bag Single-use pre-assembled
manifold

Install

Collect sample

DID YOU KNOW? Dispose

Many custom connectors have been created.
If the one you need does not exist yet,
we will design one for you.
 Anatomy of a sampling plan
Ingold® connectors
• Available in any length
•2
 independent points
of access

In-line connectors
• I deal to collect
numerous samples
between equipment
•Y
 ields a representative
sample from your
process stream

TC connectors
Bottles
•1
 /2” to 2” size with up to
10 independent access points •B
 io-neutral plastic
bottles ideal for
•A
 lso available in single-use all tests
format, pre-assembled with
the containers of your choice • Offered in multiple sizes

Disposable needle
free valve
• I deal for sampling from
disposable bags
• Welded any place needed

Sterile Syringes
•C
 ontamination free
Autoclave containers with patented design
•B
 ags and syringes ideal • I deal to save and store
for small portable tanks high value product
that are fully autoclaved
•V
 ented to withstand
the most aggressive
autoclave cycles

Accessories

Hanging rack NovaSealTM Tool Protective case Protective caps

NovaSeal™ Technology
Simple and safe disconnection
Our patented technology securely seals the tubing and separates
the flow path as the pinch pipe is crimped and cut, enabling sterile
sampling. The NovaSeal™ crimp and cut technology enables a leak
free disconnection while ensuring sterility is maintained and that the
fluid is securely protected from the outside environment at all times.
The crimping tool demonstrates robust and tight disconnections,
free from bacteria and virus. STEP 1

Place the tubing with

metallic pinch-pipe
into the die of the tool.

STEP 2

Actuate the crimper by

squeezing the handle of
the tool to complete the
crimp and cut cycle.

STEP 3

Remove the clean

cut sealed tube
from jaw set.
Peace of mind made easy
Our global network of experts are equipped
with a tremendous amount of experience and
can provide you with the support you need to
get your product to market faster.
Our Provantage® services include the
development of a robust validation plan to
help ensure your NovaSeptum® sampling
system performs within your predefined
process conditions.
To see how easy it is to use NovaSeptum® Sampling Solutions, visit: merckmillipore.com/Novaseptum
Provantage® services are available to facilitate
the most demanding qualification plans including:
• Post-use integrity testing
• Extractable & leachables
• Decontaminating agent compatability
Nevertheless, the comprehensive documentation
and training we provide ensure your qualification
process goes smoothly.
DID YOU KNOW?
With quality near 6(σ)
you get peace of mind. Using
10 NovaSeptum® systems daily,
an operator has only 50% chance
to observe a defect after 13 years*
* Data on file
NovaSeptum® Sterile Sampling System
because your drug is worth it
To find out more about NovaSeptum® Sampling visit
merckmillipore.com/Novaseptum

To place an order or receive

technical assistance
In Europe, please call Customer Service:
France: 0825 045 645
Germany: 069 86798021
Italy: 848 845 645
Spain: 901 516 645 Option 1
Switzerland: 0848 645 645
United Kingdom: 0870 900 4645

For other countries across Europe, 

please call: +44 (0) 115 943 0840

Or visit: merckmillipore.com/offices

For Technical Service visit:

merckmillipore.com/techservice

merckmillipore.com

Copyright © 2017 Merck KGaA. All Rights Reserved. Merck, Millipore, the vibrant M, NovaSeal, Provantage and NovaSeptum are Lit. No. PB1261EN00 Ver. 4.0
trademarks of Merck. All marks are the property of their respective owners. More information on our branded products and 2016 - 00673
services on www.merckmillipore.com. 02/2017