Kleenpak® Presto Sterile Connector product photo Primary L

Kleenpak® Presto Sterile Connector

Genderless sterile connections - Intuitive,
reliable, secure

The Kleenpak Presto sterile connector is the next generation in the Allegro™ range of single-use fluid handling and management devices. This new genderless connection allows for the permanent sterile connection of two fluid streams for a large range of biopharmaceutical applications.

With its intuitive operation, sterile connections can be to be carried out in a simple 3 steps operation, even in an unclassified environment, without compromising the sterility of the fluid paths.

Key design features such as the anti-actuation tabs and tamper resistance protective cap give end users more confidence in operation and security of supply.

The Kleenpak Presto sterile connector brings enhanced levels of quality assurance with 100% inspection at point of manufacture that allows device traceability, as each device has its own serial number. The manufacturing process of Kleenpak Presto sterile connectors brings an enhanced level of quality assurance, with the use of an automatic vision system that ensures the absence of defects in the membrane and membrane welding.

Available in a variety of sizes, 6.35 mm (¼ in.), 9.53 mm (⅜ in.), 12.7 mm (½ in.), 15.8 mm (⅝ in.), 19 mm (¾ in.) hose barb and 12.7 mm (½ in.) sanitary connection – the Kleenpak Presto sterile connector can be used in upstream processing, downstream processing and formulation and filling. Made from Bisphenol-A (BPA) free Polyethersulfone (PES) the Kleenpak Presto sterile connector is compatible with a wide range of process fluids and solvents.

Features and Benefits

Features Benefits
Allows for the sterile connection of 2 fluid paths in an uncontrolled environment Elimination of the need for laminar air flow hoods and glove boxes to carry out sterile connections
Genderless design Reduction of part numbers and simplification of single-use systems
Presto seal technology High pressure operation for up to 90 days
Operating temperature range 2 °C to 60 °C
Storage to -80 °C
Pressure rating from up to 3 barg for 90 days
4 barg for shorter periods
Can be used in a wide variety of applications - including tangential flow filtration (TFF) with pulsated 4 barg range
Operating pH range from 2 – 12
Compatible with Dimethylacetamide (DMA) and Dimethyl sulfoxide (DMSO)
Can be used in a wide range of processes, including antibody drug conjugates
6.35 mm (¼ in.), 9.53 mm (⅜ in.), 12.7mm (½ in.), 15.8 mm (⅝ in.), 19 mm(¾ in.) hose barb and 12.7 mm (½ in.) sanitary connections Wide range of connection sizes allows handling of different volumes – universal face allows for step up and step down connections
Tamper resistant caps on devices Enhance end user confidence between point of manufacturer and point of use
Intuitive operation Error proof operation ensures that end user makes the sterile connection the
correct way 100% of the time
Each size has a different colored cap Clear visual indication for end user on sizes being used
BPA-free PES used as material of construction Eliminates any BPA toxicological concerns
PES material compliant to USP 87, 88, 661, 85, 788 In line with regulatory expectations
Each device individually marked with batch number and serial number Device traceability that is linked to the 100% on-line inspection at point of manufacture
Vision systems on 100% of devices during manufacturing Vision system that is capable of detecting membrane and weld defects to ensure absence of critical defects




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概要

Genderless sterile connections - Intuitive,
reliable, secure

The Kleenpak Presto sterile connector is the next generation in the Allegro™ range of single-use fluid handling and management devices. This new genderless connection allows for the permanent sterile connection of two fluid streams for a large range of biopharmaceutical applications.

With its intuitive operation, sterile connections can be to be carried out in a simple 3 steps operation, even in an unclassified environment, without compromising the sterility of the fluid paths.

Key design features such as the anti-actuation tabs and tamper resistance protective cap give end users more confidence in operation and security of supply.

The Kleenpak Presto sterile connector brings enhanced levels of quality assurance with 100% inspection at point of manufacture that allows device traceability, as each device has its own serial number. The manufacturing process of Kleenpak Presto sterile connectors brings an enhanced level of quality assurance, with the use of an automatic vision system that ensures the absence of defects in the membrane and membrane welding.

Available in a variety of sizes, 6.35 mm (¼ in.), 9.53 mm (⅜ in.), 12.7 mm (½ in.), 15.8 mm (⅝ in.), 19 mm (¾ in.) hose barb and 12.7 mm (½ in.) sanitary connection – the Kleenpak Presto sterile connector can be used in upstream processing, downstream processing and formulation and filling. Made from Bisphenol-A (BPA) free Polyethersulfone (PES) the Kleenpak Presto sterile connector is compatible with a wide range of process fluids and solvents.

Features and Benefits

Features Benefits
Allows for the sterile connection of 2 fluid paths in an uncontrolled environment Elimination of the need for laminar air flow hoods and glove boxes to carry out sterile connections
Genderless design Reduction of part numbers and simplification of single-use systems
Presto seal technology High pressure operation for up to 90 days
Operating temperature range 2 °C to 60 °C
Storage to -80 °C
Pressure rating from up to 3 barg for 90 days
4 barg for shorter periods
Can be used in a wide variety of applications - including tangential flow filtration (TFF) with pulsated 4 barg range
Operating pH range from 2 – 12
Compatible with Dimethylacetamide (DMA) and Dimethyl sulfoxide (DMSO)
Can be used in a wide range of processes, including antibody drug conjugates
6.35 mm (¼ in.), 9.53 mm (⅜ in.), 12.7mm (½ in.), 15.8 mm (⅝ in.), 19 mm(¾ in.) hose barb and 12.7 mm (½ in.) sanitary connections Wide range of connection sizes allows handling of different volumes – universal face allows for step up and step down connections
Tamper resistant caps on devices Enhance end user confidence between point of manufacturer and point of use
Intuitive operation Error proof operation ensures that end user makes the sterile connection the
correct way 100% of the time
Each size has a different colored cap Clear visual indication for end user on sizes being used
BPA-free PES used as material of construction Eliminates any BPA toxicological concerns
PES material compliant to USP 87, 88, 661, 85, 788 In line with regulatory expectations
Each device individually marked with batch number and serial number Device traceability that is linked to the 100% on-line inspection at point of manufacture
Vision systems on 100% of devices during manufacturing Vision system that is capable of detecting membrane and weld defects to ensure absence of critical defects


用途

Applications

  • Media preparation and transfer
  • Buffer preparation and transfer
  • Transfer of inoculum to bioreactor
  • Sampling during fermentation / cell culture
  • Bioreactor harvest
  • Sterile fluid transfer between unit operations
  • Bulk handling of sterile material in non-classified environments
  • Probe insertion into bioreactors, mixers and 3D biocontainers
  • Sterile filtration manifolds
  • Hybrid stainless steel and single-use system connection
  • Connection of bulk sterile material to filling machine
  • Sterile waste removal from process streams

Easy-to-Use Operation

Preparation


Remove the protective cap from both connectors by pulling the tab in the direction shown above

1. Connection of the devices


Connect the two devices together ensuring the membranes are in the same direction and the blue tabs lock together – An audible click is heard.

2. Membrane removal


Remove the tabs by pulling both tabs at 90 degree to the connector assembly

3. Actuation


Actuate the assembly by turning each device into each other as shown above.

The connection is confirmed by the audible click and also the alignment of the colors as seen above.

Quality Standards

  • Manufactured under a quality management system certified to ISO9001
  • Manufactured in a clean room Class 7 in operation
  • Supplied with a certificate of test confirming the quality standards and quality control tests performed by Pall
  • Each connector is individually marked with batch number and serial number
  • Batch release criteria:
    • USP 85 - Endotoxin
    • USP 788 - Particulate test
  • Device release criteria:
    • 100% inspection through vision system for absence of membrane and weld defects.
  • The fluid path materials of construction have been tested and meet the regulatory requirements of:
    • USP 88 - Biological reactivity in vivo for Class VI 121 °C plastics
    • USP 87 - Biological reactivity in vitro
    • USP 661 - Physicochemical tests
  • The fluid path materials of construction do not contain substances derived from animal products (i.e. BSE/TSE risk free)

Validation Tests

  • Mechanical tests
  • Leak (closure integrity); burst; creep rupture and pressure hold test; tensile strength
  • Functional tests
    • Extreme temperature pressure leak test strength and performance testing
    • Water flow characteristics
    • Bacterial challenge (“soiling”) test using Brevundimonas diminuta
    • Autoclave and gamma resistance
    • Shelf life studies
    • Extractables testing
Please refer to product validation guide for further details of the validation tests performed.
仕様

Materials of Construction

Product Contact Parts

 
Connector body Polyethersulfone (PES)
O-ring Platinum cured silicone
 

Product Non-contact Parts

 
Protective cap Thermoplastic elastomer
Cover and tab Polybutylene terephthalate (PBT)
 

Extractables Matrix (NVR)

Post Irradiation and Autoclave

 
  Time
Time 0 (≤ 30 Mins) 24 Hours 7 Days
Test
Order
Solvent Temperature
Ambient (25 ºC)
40 ºC 40 ºC
1 50% Ethanol
2 0.5 N NaOH
3 0.1 M Phosphoric Acid
4 1% PS-80
5 5 M NaCl
6 WFI or Deionized Water
 
Extractables results available on request, please contact Pall.




Sterilization Specifications

 
Gamma irradiation Maximum 50 kGy
Autoclave One 75 minute cycle at 130 ºC
 

Operating Specifications

 
Up to 3 barg at 2 – 60 ºC up to 90 days
Up to 4 barg at 2 – 60 ºC up to 2 days (48 hours)
Storage down to -80 °C
 
Part Number PSC1G07 PSC1G10 PSC1G06 PSC1G11 PSC1G08 PSC1G05
Size 6.35 mm
(¼ in.)
Hose barb
9.53 mm
(⅜ in.)
Hose barb
12.7 mm
(½ in.)
Hose barb
15.88 mm
(⅝ in.)
Hose barb
12.7 mm
(½ in.)
Sanitary
19 mm
(¾ in.)
Hose barb
Internal diameter (A) 6 mm
(0.2 in.)
8 mm
(0.3 in.)
14 mm
(0.6 in.)
14 mm
(0.6 in.)
13 mm
(0.5 in.)
14 mm
(0.6 in.)
Length when actuated (B) 97 mm
(3.8 in.)
97 mm
(3.8 in.)
108 mm
(4.3 in.)
120 mm
(4.7 in.)
99 mm
(3.9 in.)
140 mm
(6 in.)
Connector length with cap (C) 58 mm
(2.3 in.)
58 mm
(2.3 in.)
64 mm
(2.5 in.)
70 mm
(2.8 in.)
59 mm
(2.3 in.)
79 mm
(3 in.)
Maximum diameter of connector with cap (D) 70 mm
(2.8 in.)
70 mm
(2.8 in.)
70 mm
(2.8 in.)
70 mm
(2.8 in.)
70 mm
(2.8 in.)
70 mm
(2.8 in.)
Maximum diameter of connected device (E) 49 mm
(1.9 in.)
49 mm
(1.9 in.)
49 mm
(1.9 in.)
49 mm
(1.9 in.)
49 mm
(1.9 in.)
49 mm
(1.9 in.)
Weight 28 g 30 g 30 g 44 g 30 g 41 g




型式
 
Part Number Description Quantity
PSC1G07 Box of 50 Kleenpak Presto sterile connectors with ¼ in. hose barb connection (Orange Protective Cap) 50 devices per box individually bagged in a large outer bag
PSC1G10 Box of 50 Kleenpak Presto sterile connectors with ⅜ in. hose barb connection (Light Blue Protective Cap) 50 devices per box individually bagged in a large outer bag
PSC1G06 Box of 50 Kleenpak Presto sterile connectors with ½ in. hose barb connection (White Protective Cap) 50 devices per box individually bagged in a large outer bag
PSC1G11 Box of 50 Kleenpak Presto sterile connectors with ⅝ in. hose barb connection (Spearmint Green Protective Cap) 50 devices per box individually bagged in a large outer bag
PSC1G08 Box of 50 Kleenpak Presto sterile connectors with ½ in. mini sanitary clamp connection (Black Protective Cap) 50 devices per box individually bagged in a large outer bag
PSC1G05 Box of 50 Kleenpak Presto sterile connectors with ¾ in. hose barb connection (Purple Protective Cap) 50 devices per box individually bagged in a large outer bag
 




産業分野
Single-Use Solutions