Quickseal®

Aseptic
Disconnections

Validation Guide
 All third-party trademarks mentioned in this brochure
belong to the following proprietors:
Pumpsil® is a registered trademark of
Watson-Marlow Limited
STHT®-C is a registered trademark of St. Gobain
Performance Plastics Corporation
C-Flex® is a registered trademark of St. Gobain
Performance Plastics Corporation
Pharmed® is a registered trademark of St. Gobain
Performance Plastics Corporation
Bioprene® is a registered trademark of
Watson-Marlow Limited
LpH® is a registered trademark of Steris Corporation
Vesphene® is a registered trademark of Steris Corporation
Spor-Klenz® is a registered trademark of Steris Corporation
Elastosil® is a registered trademark of Wacker Chemie AG
Disclaimer AdvantaSil™ is a trademark of NewAge Industries Inc
The results shown in this Validation Guide are indicative AdvantaFlex® is a registered trademark of NewAge
and do not constitute product specifications. Industries Inc.
Quickseal® is a registered trademark of Allpure
This document, including any attachments, Technologies, LLC
contains confidential and proprietary information Flexboy® is a registered trademark of
of Sartorius. Disclosure, copying or distribution to any third Sartorius Stedim FMT SAS
party of the information included Confidence® is a registered trademark of
in this document is prohibited without the prior written Sartorius Stedim Biotech GmbH
consent of Sartorius. To obtain authorization, please contact Dow Corning® is a registered trademark of
Sartorius through your regular contact person. Dow Corning ­Corporation
2
Table of Contents
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5. Leachables and Extractables . . . . . . . . . . . . . . . . . . . . . . . . 19
1.1 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 Scope Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6. Quickseal® Cutting Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
1.3 Security of Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6.1 Large Diameter Quickseal® Cutting Tool . . . . . . 20
1.4 Manufacturing Resources . . . . . . . . . . . . . . . . . . . . . . 5 6.2 Small Diameter Quickseal® Cutting Tool . . . . . . 20
1.5 cGMP Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . 6
1.6 Gamma Irradiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 7. Quickseal® Protective Caps . . . . . . . . . . . . . . . . . . . . . . . . . 21
1.7 Validation Test Summary . . . . . . . . . . . . . . . . . . . . . . . . 7 7.1 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

2. Production and Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.1 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.3 Supply Chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.3.1 Supplier Evaluation and ­Qualification . . . . . . . . . . 9
2.3.2 Component and Raw Material Qualification . . . . 9
2.3.3 Incoming Quality Controls . . . . . . . . . . . . . . . . . . . . . . 9

3. Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.1 Equipment Qualification . . . . . . . . . . . . . . . . . . . . . . 10
3.2 Production Environment . . . . . . . . . . . . . . . . . . . . . . 10
3.2.1 Viable Organism Control and Monitoring . . . . . 10
3.2.2 Non-Viable Control and Monitoring . . . . . . . . . . . 10
3.3 Material Receipt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.4 Traceability and Batch Control . . . . . . . . . . . . . . . . . 11
3.5 In-Process and Product Release Controls . . . . . . 11

4. Quickseal® Product Properties . . . . . . . . . . . . . . . . . . . . . . 12

4.1 Quickseal® Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.1.1 Silicone Quickseal® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.1.2 TPE Quickseal® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.2 Quickseal® Shelf-Life . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.2.1 Non-Irradiated Quickseal® . . . . . . . . . . . . . . . . . . . . . 12
4.2.2 Gamma Irradiated Quickseal® . . . . . . . . . . . . . . . . . . 12
4.3 Quickseal® Product Sizes . . . . . . . . . . . . . . . . . . . . . . . 13
4.4 Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.4.1 Disconnection Qualification . . . . . . . . . . . . . . . . . . . . 13
4.4.2 Push-Pull Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.4.3 Burst Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.4.4 Tensile Strength Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.4.5 Bacterial Challenge Testing | Container
Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.4.6 Low Temperature Bacterial Challenge
Testing | Container Closure . . . . . . . . . . . . . . . . . . . . . 18

3
1. Introduction
Quickseal® aseptic disconnect is a component of an assembly that may be used in a variety of process areas for and in
support of the discovery, development and clinical or commercial production of drug products such as vaccines,
recombinant proteins and monoclonal antibodies.

Quickseal® aseptic disconnect components are qualified, manufactured and released under a quality control system which
is compliant to the key principles of cGMP.

Validation, as used in these guidelines, comprises the systematic testing of essential production steps and production
equipment, including testing and inspection of final products with the goal of ensuring that the finished products can
be reliably and reproducibly manufactured, in respect with the established production and quality control procedures.

We have compiled this Validation Guide so that users of Quickseal® aseptic disconnect can plan, implement and
document their own validation procedures.

4
1.1 Product Description This Validation Guide is applicable for both Quickseal®
aseptic disconnect sold as a standalone product
Quickseal® reduces operating times and improves and pre-assembled on Sartorius fluid management
reliability for biopharmaceutical and other high-purity systems. Wherever possible, Sartorius refers to our
fluid handling industries. supplier’s product validation documentation. Supplier
documentation is available on request or by contacting the
The Quickseal® aseptic disconnect are used after supplier directly.
fluid transfer to disconnect single-use transfer lines
and bag assemblies used in biopharmaceutical
applications. Quickseal® aseptic disconnect provide
aseptic disconnection in non-classified and classified 1.3 Security of Supply
environments, while maintaining product sterility.
Assurance and security of supply is a significant
Quickseal can be included as a component on single-
®
market requirement for Quickseal® aseptic disconnect.
use tube, bag or bottle assemblies, sampling manifolds, The robustness of our supply chain relies on effective
single-use bioreactors and more. supplier management, multiple manufacturing sites
with consistent industrial and quality processes, process
Quickseal® can be installed on a variety of tube materials automation, application of lean manufacturing practices,
across a range of tube sizes. The tubing runs continuously expertise for designing fluid management systems, close
through the collar for an uninterrupted fluid path. collaborative relationships with customers and senior
management’s strong commitment to continuous
and dynamic improvement.

1.2 Scope Statement

The validation contained in this guide applies, unless 1.4 Manufacturing Resources
otherwise noted, to the following tubing materials:
Sartorius’ manufacturing resources for Quickseal® aseptic
Platinum-Cured Silicone disconnect operate under strictly controlled manufacturing
Watson-Marlow Pumpsil®
procedures and quality system.

Dow Corning Dow Pharma-50

New Oxford, Pennsylvania –
St. Gobain STHT®-C United States of America
AdvantaPure AdvantaSil™ 80 Progress Avenue
New Oxford, PA 19460

Thermoplastic Elastomer Total Facility Size:

St. Gobain C-Flex®
ƒ 17,000 ft²
ƒ ISO 7 Manufacturing and Raw Materials: 3,100 ft²
AdvantaPure AdvantaFlex®

St. Gobain Pharmed® Manufacturing Competencies

Watson-Marlow Bioprene ® ƒ Quickseal® manufacturing
ƒ Subcomponent assembly
Please contact us for an evaluation or confirmation of ƒ Final assembly
alternative tubings. ƒ Packaging and labeling

5
1.5 cGMP Quality Assurance
Our documented quality system is consistent with industry-
recognized quality standards including the following:

The FDA current Good Manufacturing Practices (cGMPs)

Note:
Sartorius is not a manufacturer of finished pharmaceuticals
or finished medical devices, yet we have chosen to align our
quality system clauses of 21 CFR parts 210, 211 and 820 that
apply to our processes and products.

These quality system processes direct and inform our entire

quality system and all the procedures, work instructions,
forms, etc., contained therein:

ƒ Management responsibility and review

ƒ Document control
ƒ Records control and retention
ƒ Corrective and preventive action internal auditing
ƒ Personnel training and competency
ƒ Customer notification and recall

1.6 Gamma Irradiation

Quickseal® aseptic disconnect is suitable for gamma
irradiation up to 50 kGy.

Quickseal® aseptic disconnect is a component included on

multi-component assemblies which have been validated to
sterility assurance level (SAL) 10-⁶ per ISO 11137.

6
1.7 Validation Test Summary

Qualification Tests Monitoring Tests Lot Release Tests

ƒ Disconnection (0 – 2 bar) ƒ Particulate control ƒ 100% Visual inspection

ƒ ISO 14644-1: clean-rooms ƒ Visible particulate
ƒ Push-Pull Test (after disconnect) and associated controlled ƒ Component defects
environments
ƒ Burst Test (after disconnect) ƒ Classification of air cleanliness ƒ Compliance to technical
by particle concentration drawing | specification
ƒ Tensile Pull Test (after disconnect)
ƒ Bioburden and sterility ƒ Packaging and labeling
ƒ Microbial Ingress (after disconnect) ƒ ISO 14698: clean-rooms
and associated
ƒ Material Tests (tubing dependent) controlled environments –
ƒ USP 87 biocontamination control
ƒ USP 88
ƒ USP 85
ƒ USP 661
ƒ USP 381
ƒ USP 788
ƒ 21CFR177.2600
ƒ TSE | BSE risk
ƒ Reach
ƒ Melamine
ƒ Bisphenol A

7
Quickseal® aseptic disconnect does not introduce a new fluid contact surface, so many validation properties are
carried over from validation testing performed on the tubing, by the tubing manufacturer. Some material validation
information from our tubing suppliers is confidential – Sartorius suggests contacting the tubing supplier directly for tubing
material information.

Tubing Supplier Tubing Brand USP 87 USP 88 USP 85 USP 661 USP 381 21CFR177.2600 USP 788

Watson-Marlow Pumpsil ®
Yes Yes Yes Yes Yes Yes Yes

Dow Corning Dow Pharma-50 Yes Yes - Yes Yes Yes Yes

St. Gobain STHT-C ®

Yes Yes Yes Yes Yes Yes Yes

AdvantaPure AdvantaSil™ Yes Yes Yes Yes Yes Yes -

Tubing Supplier Tubing Brand USP 87 USP 88 USP 85 USP 661 USP 381 21CFR177.2600

St. Gobain C-Flex ®

Yes Yes Yes Yes Yes Yes

AdvantaPure AdvantaFlex ®
Yes Yes Yes Yes Yes Yes

St. Gobain Pharmed ®

- Yes Yes - Yes Yes

Watson-Marlow Bioprene ®
Yes Yes Yes Yes Yes Yes

8
2. Production and Quality
2.1 Personnel 2.3.2 Component and Raw
Material Qualification
Sartorius recognizes that human resources and personnel
competency are of utmost importance and have therefore
established a comprehensive human resources Each raw material and | or component is qualified. This
management program. Stringent selection, motivation, qualification includes a list of required statements from
initial and continuous training and qualification of the supplier that is dependent on the final use of the
personnel at all levels of the company ensure that every component and | or raw material. Typical requirements for
employee is at his or her best at all times for each step of components that are in contact with the product flow are
the manufacturing and control processes. Comprehensive the following (non-exhaustive list):
training records are kept for all employees. ƒ USP Class VI and | or ISO 10993 conformity
ƒ TSE | BSE statement
ƒ EP conformity (if applicable)
ƒ Change notification statement
2.2 Facilities ƒ Reach compliance
ƒ Bisphenol A free
The buildings, equipment and work environment at
Sartorius have been designed to maximize employee Beyond these requirements, Sartorius may perform
comfort and safety, while complying with the key principles qualification of the proposed component and | or raw
of GMP for the manufacture of Quickseal® aseptic material internally.
disconnect destined to the pharmaceutical industry. All
infrastructure (equipment, utilities, etc.) For raw materials, the internal qualification will include
that has an impact on the product quality is inventoried physical performance of the component made with this
and undergoes an appropriate qualification, calibration raw material.
and maintenance.
For components, the qualification will be centered on the
testing of the assembly of the new component with other
components that will be attached.
2.3 Supply Chain

2.3.1 Supplier Evaluation 2.3.3 Incoming Quality Controls

and ­Qualification
All raw materials, components and sub-contracted products
Suppliers are carefully selected according to internal are inspected on arrival at Sartorius against approved
standards and applicable regulations. Typical requirements control specifications. Typical testing requirements applied
for suppliers are the following (non-exhaustive list): at incoming quality inspection
ƒ Quality control system are (non-exhaustive list):
ƒ Quality assurance system ƒ Supplier documentation controls (certificates)
ƒ Facility and clean-room controls ƒ Packaging identification and integrity
ƒ Product | component lot traceability system ƒ Visual inspection
ƒ Change notification procedures ƒ Dimensional check

Suppliers are evaluated and approved according to Only approved materials will be allowed to be used in
internal standards. production of Quickseal® aseptic disconnect. Approved
materials are recorded in Sartorius’ inventory and quality
management system, labeled
with an internal lot number and designated internal part
number and released for use.

9
3. Production
3.1 Equipment Qualification 3.2.2 Non-Viable Control
and Monitoring
All equipment used in production goes through
qualification that includes installation qualification,
operational qualification and performance qualification. Line clearance, weekly cleaning of equipment and work
This qualification effort is carried out by a multidisciplinary surfaces and monthly cleaning of the clean-room reduces
team and follows the rules described in the corresponding and controls non-viable particles.
procedure in our quality system.
Non-viable readings are recorded weekly to ensure
Equipment undergoes its applicable calibration 0.5 μm/m³ and 5.0 μm/m³ particles are within the
schedule, according to the calibration plan described ISO Class 7 acceptance criteria, per ISO 14644-1.
in our quality system.

3.3 Material Receipt

3.2 Production Environment
Components received at New Oxford arrive in two forms;
Product manufacturing occurs in an ISO 7 (Class 100,000 double-bagged and clean or bulk-packed. Double-bagged
clean-room) per ISO 14644-1 and in accordance with the and clean materials (e.g. tubing) are received into our
key principles of cGMPs. Class 7 clean-room per incoming inspection and
testing procedures.
Contact us for further details or precise questions about
our quality and operating systems or to schedule an Bulk-packed items are cleaned and transferred into the
on-site audit. clean-room per incoming inspection and testing procedures.

3.2.1 Viable Organism Control

and Monitoring

In addition to line clearance and weekly cleaning of

equipment and work surfaces, monthly cleaning of the
clean-room with a schedule of LpH®, Vesphene® and
Spor-Klenz® takes place as per our clean-room
management and cleaning procedures.

Viable organisms are measured quarterly to monitor

the effectiveness of the clean-room management and
cleaning procedures and to be compliant to EU GMPs
and ISO 14698. As of the drafting of this document,
viable monitoring is up to date:

Air Viables < 100 CFU

Surface Viables < 25 CFU
Wall Viables < 5 CFU

10
3.4 Traceability and Batch Control 3.5 In-Process and Product
Release Controls
Sartorius has a process and maintains
an effective traceability system which can be used in the
event of product, component or manufacturing issue to Quality controls are performed at various stages during
alert impacted customers. the manufacturing process. Some of these controls are
listed below. Other specific controls, dependent on the
Generally, all finished assemblies are composed of specific application of the products, may be performed
components and sub-assemblies. Sub-assemblies are but are not listed.
built from components or sub-assemblies. Components ƒ Product conformity against technical drawing
are parts that are purchased or manufactured by or specifications
Sartorius. Each component and sub-assembly has a unique ƒ Visual inspection (particles or contamination,
part number. All components correctness assembly, etc.)
and sub-assemblies are assigned a unique lot number ƒ Product packaging controls
on receipt or manufacture | assembly. The lot number ƒ Product labeling controls
is recorded in batch records and maintained in our
traceability system. After production, every batch of finished products is
released by quality assurance before it can be shipped.
Batch records provide the operators all the necessary The release will be documented in the batch record and
instructions and component and sub-assembly list to in the traceability system.
execute the designated procedure. Operators fill in batch
records including recording lot numbers of components The system for product release is constructed in such a way
and sub-assemblies. This data is also entered into the that only batches that have been released by quality can
traceability system. have the corresponding shipping and billing documents.

The traceability system and batch record system links all A certificate of release is issued for each batch of finished
manufacturing steps, components and sub-assemblies to product that is shipped from Sartorius.
the final assembly, allowing for complete backward and
forward traceability of every assembled product.

11
4. Quickseal® Product Properties
4.1 Quickseal® Structure 4.1.2 TPE Quickseal®
Quickseal® aseptic disconnect is an aluminum (3003) The Quickseal® collar is bonded to the TPE tubing
collar bonded to a length of elastomeric tubing. The tubing using a thermoplastic tie layer. The tie layer has block
runs continuously through the Quickseal® collar for an copolymer composition which microphase separates into
uninterrupted fluid-pathway. A Quickseal® cutting tool functional domains:
cuts and compresses the collar, squeezing the walls of the ƒ For adhesion with the backbone of the block copolymer
tubing together to create a mechanical seal. The cut collar of the TPE (eg. Styrene isobutylene styrene)
maintains compression of the tubing to retain the closure. ƒ For adhesion to the oxide functionality of the aluminum
Quickseal® collar
Quickseal® aseptic disconnect is commercially available
on a variety of platinum-cured silicone and thermoplastic The heat cycle applied during Quickseal® manufacture
elastomer (TPE) tubing. melts the tie layer to fuse together the TPE tubing and the
aluminum collar, creating a durable bond without solvent
based adhesives.

4.1.1 Silicone Quickseal®

The Quickseal® collar is bonded to the tubing using 4.2 Quickseal® Shelf-Life
a platinum-curable liquid silicone. The liquid silicone
undergoes a crosslinking or vulcanization reaction which
produces a three dimensional network of silicone chains 4.2.1 Non-Irradiated Quickseal®
which are rendered insoluble, intractable and infusible.
A heat cycle accelerates curing between the collar and Section 4.1 describes the structure of Quickseal® and
the tubing, as is the case of silicone. demonstrates that the addition of the Quickseal® collar
makes no ­significant change to the tubing material.
The composition of the liquid silicone adhesive is:
ƒ 99.95 wt % Elastosil® LR3003/50 A,B platinum- As such, the Quickseal® assembly carries the remaining
cured silicone shelf-life of the tubing material. Tube materials described in
ƒ 0.05 wt % multifunctional silane coupling agent this Validation Guide arrive at Sartorius’ site with five year
shelf-life. Sartorius’ inventory management procedures
The silane coupling agent achieves adhesion between the ensure the tubing is converted into Quickseal® assembly
silicone tubing and the aluminum collar. This compound within two years of receipt.
has dual functionality: silanol groups and vinyl groups.
Thus, non-irradiated Quickseal® assemblies have a
The methoxy groups hydrolyze to form silanol groups which shelf-life of three years.
react with hydroxyl groups on the surface of the aluminum,
thus attaching the adhesive to the aluminum, as well as
hydroxyl groups on the silicone tubing, therefore covalently
attaching to the tubing. This hydrolysis reaction occurs 4.2.2 Gamma Irradiated Quickseal®
above 125 °C and occurs when the aluminum collar is
attached to the silicone tubing. Section 4.4 describes the validation testing of critical
performance ­attributes of Quickseal® after gamma
The second functionality of the silane coupling agent is that irradiation (50 kGy) and aging to three years.
of a double bond which hydrosilylates into the vulcanizing
adhesive, along with the vinyl groups which are on the ends All critical attributes were met. Shelf-life of Quickseal®
of the base polymer. Thus, the silane coupling agent reacts assemblies after irradiation to 50 kGy is three years.
to all three materials: the aluminum collar, the silicone
tubing and to the adhesive itself.

12
4.3 Quickseal® Product Sizes
Tube Size Inches ⅛ 3⁄16 ¼ ⅜ 7⁄16 ½ ⅝ ¾ 1 1⅛
(outer diameter)
mm ≈ 3.2 ≈ 4.8 ≈ 6.4 ≈ 9.6 ≈ 11.1 ≈ 12.7 ≈ 15.9 ≈ 19.0 ≈ 25.4 ≈ 28.6

4.4 Properties

4.4.1 Disconnection Qualification

Sartorius performed an evaluation of the disconnection of Quickseal® under various conditions. All assemblies were filled
with water and installed to a rig so that pressure in the tubing could be controlled. The cut collar
was inspected for water leaks during disconnection and blotted on absorbent paper after disconnection.

Passing results achieved if no leaks are noted and no moisture is observed on absorbent paper.

Aging Gamma Autoclave Pressure at Disconnection Pass | Fail

Irradiation (2 × 134 °C, 30 min) [bar]

Platinum-cured silicone No No No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

Platinum-cured silicone No 50 kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass

Platinum-cured silicone 12 months 50 kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass

Platinum-cured silicone 18 months 50kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass

C-Flex® TPE No No No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

C-Flex® TPE No 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

C-Flex® TPE 12 months 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

C-Flex TPE
®
18 months 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

13
4.4.2 Push-Pull Test
Sartorius performed an evaluation of the disconnection of Quickseal® under various conditions.
All assemblies were filled with water and disconnection was performed. The tubing assembly with cut collar was
manipulated by hand including bending the tubing and pushing and pulling at the cut collar. Pressure was increased
and manipulations repeated.

Passing results achieved if no leaks were observed.

Aging Gamma Autoclave Pressure at Push | Pull Pass | Fail

Irradiation (2 × 134 °C, 30 min) [bar]

Platinum-cured silicone No No No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

Platinum-cured silicone No 50 kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass

Platinum-cured silicone Six months 50 kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass
(after disconnect)
ambient temp

Platinum-cured silicone Six months 50 kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass
(after disconnect)
5.7 °C

Platinum-cured silicone 12 months uncut + 50 kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass
six months after
disconnect
(accelerated)

Platinum-cured silicone 36 months uncut + 50 kGy Yes Ambient, 0.5, 1.0, 1.5, 2.0 Pass
six months after
disconnect
(accelerated)

C-Flex® TPE No No No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

C-Flex TPE
®
No 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass

C-Flex TPE
®
Six months 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass
(after disconnect)
ambient temp

C-Flex® TPE Six months 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass
(after disconnect)
5.7 °C

C-Flex® TPE 12 months uncut + 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass
six months after
disconnect
(accelerated)

C-Flex® TPE 36 months uncut + 50 kGy No Ambient, 0.5, 1.0, 1.5, 2.0 Pass
six months after
disconnect
(accelerated)

14
4.4.3 Burst Testing
Sartorius performed burst testing on Quickseal® aseptic disconnect after certain conditions.
All assemblies were filled with water and disconnection was performed. Pressure in the tubing assembly with cut
collar was increased by 0.5 bar increments until failure.

Aging Gamma Autoclave Burst Pressure

Irradiation (2 × 134 °C, 30 min) [bar]

Platinum-cured silicone No No No 5.5

Platinum-cured silicone No 50 kGy Yes 5.5

Platinum-cured silicone Six months 50 kGy Yes 5.5

(after disconnect)
ambient temp

Platinum-cured silicone Six months 50 kGy Yes 5.5

(after disconnect)
5.7 °C

Platinum-cured silicone 12 months uncut + 50 kGy Yes 5.5

six months after
disconnect
(accelerated)

Platinum-cured silicone 36 months uncut + 50 kGy Yes 5.5

six months after
disconnect
(accelerated)

C-Flex® TPE No No No 5.5

C-Flex TPE
®
No 50 kGy No 4.0

C-Flex TPE
®
Six months 50 kGy No 3.5
(after disconnect)
ambient temp

C-Flex® TPE Six months 50 kGy No 4.0

(after disconnect)
5.7 °C

C-Flex® TPE 12 months uncut + 50 kGy No 4.0

six months after
disconnect
(accelerated)

C-Flex® TPE 36 months uncut + 50 kGy No 4.0

six months after
disconnect
(accelerated)

15
4.4.4 Tensile Strength Test
Sartorius performed tensile strength test on Quickseal® aseptic disconnect after certain conditions.
The force to pull the collar off the tubing was measured. Traction speed was 500 mm/min. Passing results achived
when force > 40N.

Aging Gamma Autoclave Average Force

Irradiation (2 × 134 °C, 30 min) [N]

Platinum-cured silicone No No No 134.5

Platinum-cured silicone No 50 kGy Yes 124.6

Platinum-cured silicone Six months 50 kGy Yes 109.3

(after disconnect)
ambient temp

Platinum-cured silicone Six months 50 kGy Yes 132.4

(after disconnect)
5.7 °C

Platinum-cured silicone 12 months uncut + 50 kGy Yes 100.6

Six months after
disconnect
(accelerated)

Platinum-cured silicone 36 months uncut + 50 kGy Yes 118.0

six months after
disconnect
(accelerated)

C-Flex® TPE No No No 87.6

C-Flex TPE
®
No 50 kGy No 69.0

C-Flex TPE
®
Six months 50 kGy No 73.6
(after disconnect)
ambient temp

C-Flex® TPE Six months 50 kGy No 74.9

(after disconnect)
5.7 °C

C-Flex® TPE 12 months uncut + 50 kGy No 75.6

six months after
disconnect
(accelerated)

C-Flex® TPE 36 months uncut + 50 kGy No 62.1

six months after
disconnect
(accelerated)

16
4.4.5 Bacterial Challenge Testing | Container Closure
Sartorius performed bacterial challenge test on Quickseal® aseptic disconnect after certain conditions.

Quickseal® test articles were assembled to connect two Flexboy® bags to each other and gamma irradiated to 50 kGy.
The assemblies were filled with casein peptone soybean digest broth and incubated for seven days at 32 °C ± 2 °C. All
assemblies showed no signs of contamination so the Quickseal® collars were cut.

Bacteria used in the tests was bacillus atrophaeus (ATCC 9372). Tests for inhibition demonstrated that the Quickseal®
assembly does not inhibit growth of bacillus atrophaeus.

Aging Bacterial Challenge Observation After Incubation

Seven Days at 32 °C ± 2 °C

Platinum-cured silicone No None No growth

Negative control pass

Platinum-cured silicone No Bacteria injected into assemblies Positive growth

(concentration 6.4 × 10³) Positive control pass

Platinum-cured silicone No Immersed into bacterial solution No growth

(concentration 6.4 × 10⁹) Test passed

Platinum-cured silicone Six months None No growth

Negative control pass

Platinum-cured silicone Six months Bacteria injected into assemblies Positive growth
(concentration 6.4 × 10³) Positive control pass

Platinum-cured silicone Six months Immersed into bacterial solution No growth

(concentration 6.4 × 10⁹) Test passed

C-Flex® TPE No None No growth

Negative Control pass

C-Flex® TPE No Bacteria injected into assemblies Positive growth

(concentration 6.4 × 10³) Positive control pass

C-Flex® TPE No Immersed into bacterial solution No growth

(concentration 6.4 × 10⁹) Test passed

C-Flex® TPE Six months None No growth

Negative control pass

C-Flex® TPE Six months Bacteria injected into assemblies Positive growth
(concentration 6.4 × 10³) Positive control pass

C-Flex® TPE Six months Immersed into bacterial solution No growth

(concentration 6.4 × 10⁹) Test passed

17
4.4.6 Low Temperature Bacterial Challenge
Testing | Container Closure

Sartorius performed bacterial challenge Test on Quickseal®

aseptic disconnect with a freeze | thaw cycle.

Platinum-cured silicone and C-Flex® tubes with Quickseal®

collars were filled with sterile medium supportive of
bacterial growth. The collars were cut and the samples were
placed in a freezer at -60 °C to -100 °C for 48 hours. The
samples were thawed and then immersed the tubes into
a bacterial solution (brevundimonas diminuta). During
immersion the system is cycled between positive 15 psig
and negative 10 psig.

Fluid from the sealed tubing is plated, in triplicate, on

soybean casein digest agar (SCDA) and incubated for
seven days at 30 °C ± 2 °C and observed for growth of
organisms as indicated by colony forming units (CFU).

All test articles were negative for growth indicating

the cut Quickseal® may be frozen. Care should be taken
when handling components at or below their glass
transition temperatures.

Positive controls were positive for growth.

Negative controls were negative for growth.

18
5. Leachables and Extractables
Leachables and extractables are compounds that have
the potential to or will actually leach from the materials of
the fluid handling system into the solution.

A risk assessment is advised to determine the extent

of leachable and extractable studies are required.
Considerations should include; the production stage,
exposure time and temperature, exposure surface area,
material familiarity and the process fluid pH and polarity.

Testing requirements for items of low risk may be

adequately met by USP <87> and USP <88>, which are
extractable studies. These studies do not identify or
quantify compounds leaching the materials. Instead,
these studies measure biologic and cytotoxic effects
of leachables from the materials under the defined
extraction parameters.

The fluid contact surface of Quickseal® assemblies is

the tubing to which it is attached. All tubing materials
offered with Quickseal® pass USP <87> and USP
<88> testing. Confidential information about leachable
and extractable studies may be available from our
component manufacturers.

Sartorius’ Confidence® Services is available to perform

customized and confidential extractable and leachable
studies on polymer-based process components.

19
6. Quickseal® Cutting Tools
Sartorius offers two cutting tools to complete the disconnection and create the seal with Quickseal®.

6.1 Large Diameter Quickseal®

Cutting Tool

Large Diameter Cutting Tool

Tube size | Quickseal® cut range ≤ 1.125" (≈ 28.6 mm)

outer diameter

Materials of construction (cutting head) 304 stainless steel

Weight 4 lbs
2.2 kg

Width 2"
60 mm

Depth 4.25"
108 mm

Length 14.75"
375 mm

Sound < 80 dB at one meter

Vibration < 2.5 m/s²

Cutting time Four seconds

Closing speed 6 mm/second

Cuts per charge ≈ 300

Battery voltage 18 V, lithium ion

Charging time 20 minutes

6.2 Small Diameter Quickseal®

Cutting Tool

Small Diameter Cutting Tool

Tube size | Quickseal® cut range ≤ 0.25" (≈ 6.4 mm)

outer diameter

Materials of construction (cutting head) 304 stainless steel

Weight 4 lbs
2.2 kg

Width 0.5"
13 mm

Depth 1.125"
27 mm

Length 8.125"
206 mm

20
7. Quickseal® Protective Caps
The Quickseal® protective caps can be installed after collars are cut. The caps are made from silicone so are very
flexible, durable and have a wide temperature range.

7.1 Installation
Installation is simple:
ƒ Grasp the cap near the open end between index
finger and thumb
ƒ Squeeze the cap until the opening is wide enough
for the cut Quickseal® collar
ƒ Insert the Quickseal® collar and release

21
Germany USA
Sartorius Stedim Biotech GmbH Sartorius Stedim North America Inc.
August-Spindler-Strasse 11 565 Johnson Avenue
37079 Goettingen Bohemia, NY 11716
Phone +49 551 308 0 Toll-Free +1 800 368 7178

F
 or further contacts, visit
www.sartorius.com

Specifications subject to change without notice.

© 2021 Sartorius Stedim FMT S.A.S., Avenue de Jouques - Zone Industrielle Les Paluds - C.S. 91051, 13781 Aubagne Cedex, France

Publication No.: SPK-5706-e | Order No.: 85037-560-19 | Status: 10 | 15 | 2021