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.

Kleenpak® Presto Sterile Connector

Product images are a representation of product family for illustration purposes only. Actual products may vary.

Kleenpak® Presto sterile connector, ¼ in. hose barb connection, box of 50

Product ID: PSC1G07
Unit of Measure
1/BOX
Min Order Qty
1
Internal Diameter (Metric)
6 mm
Connection
¼ in hose barb
O-Ring Material
Platinum-cured silicone (in fluid path)
Connector Body Material
Polyethersulfone (PES) (in fluid path)
Minimum Operating Temperature
2 °C
Maximum Operating Temperature
60 °C
See All Attributes
$ 2,183.00

Kleenpak® Presto sterile connector, ½ in. hose barb connection, box of 50

Product ID: PSC1G06
Unit of Measure
1/BOX
Min Order Qty
1
Internal Diameter (Metric)
14 mm
Connection
½ in hose barb
O-Ring Material
Platinum-cured silicone (in fluid path)
Connector Body Material
Polyethersulfone (PES) (in fluid path)
Minimum Operating Temperature
2 °C
Maximum Operating Temperature
60 °C
See All Attributes
$ 2,183.00

Kleenpak® Presto sterile connector, ½ in. mini sanitary clamp connection, box of 50

Product ID: PSC1G08
Unit of Measure
1/BOX
Min Order Qty
1
Internal Diameter (Metric)
13 mm
Connection
½ in mini sanitary clamp
O-Ring Material
Platinum-cured silicone (in fluid path)
Connector Body Material
Polyethersulfone (PES) (in fluid path)
Minimum Operating Temperature
2 °C
Maximum Operating Temperature
60 °C
See All Attributes
$ 2,183.00

Kleenpak® Presto sterile connector, ¾ in. hose barb connection, box of 50

Product ID: PSC1G05
Unit of Measure
1/BOX
Min Order Qty
1
Internal Diameter (Metric)
14 mm
Connection
¾ in hose barb
O-Ring Material
Platinum-cured silicone (in fluid path)
Connector Body Material
Polyethersulfone (PES) (in fluid path)
Minimum Operating Temperature
2 °C
Maximum Operating Temperature
60 °C
See All Attributes
$ 2,183.00

Kleenpak® Presto sterile connector, ⅜ in. hose barb connection, box of 50

Product ID: PSC1G10
Unit of Measure
1/BOX
Min Order Qty
1
Internal Diameter (Metric)
8 mm
Connection
⅜ in hose barb
O-Ring Material
Platinum-cured silicone (in fluid path)
Connector Body Material
Polyethersulfone (PES) (in fluid path)
Minimum Operating Temperature
2 °C
Maximum Operating Temperature
60 °C
See All Attributes
$ 2,183.00

Kleenpak® Presto sterile connector, ⅝ in. hose barb connection, box of 50

Product ID: PSC1G11
Unit of Measure
1/BOX
Min Order Qty
1
Internal Diameter (Metric)
14 mm
Connection
⅝ in hose barb
O-Ring Material
Platinum-cured silicone (in fluid path)
Connector Body Material
Polyethersulfone (PES) (in fluid path)
Minimum Operating Temperature
2 °C
Maximum Operating Temperature
60 °C
See All Attributes
$ 2,183.00

Description

Kleenpak Presto Connector

With its intuitive operation, sterile connections can be to be carried out in a simple three-step 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-resistant 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 Benefits
Allows for the sterile connection of two 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.), 12.7 mm (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

 

Testimonials

The Pall Kleenpak Presto sterile connector is a welcome addition to the space of aseptic connections in the bio-pharmaceutical industry. It overcomes some of the major downsides of other connection technologies with unique attributes and error-proofing designs.

 

  • The tamper-proof cover ensures that the critical membrane surface is not disturbed, unlike alternative devices with covers which can be removed and replaced.
  • The pull tabs include a rigid “guide track” which ensures the operator pulls the tabs perpendicular to the device. This avoids many possible failure modes that are present with competitor’s devices.
  • The twist-to-lock mechanism provides visual indication of a successful connection, but also reduces the force required to pull the membranes because the full compressive force between the two halves is not engaged until after membrane removal and twisting. The twisting mechanism is intuitive and does not add significant complexity to the connection.

 

The Kleenpak Presto sterile connector is my first recommendation for connection of single-use systems because none of the other devices on the market combine all of these attributes with a compact form-factor. The extensive validation data provided by Pall reduced the resources needed to implement these devices and provides assurance of their ability to maintain aseptic fluid pathways in our manufacturing processes.

 

- Single-Use Design Engineer, Major Pharmaceutical company

Applications

Kleenpak® Presto Sterile Connector
  • 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

Kleenpak® Presto Sterile Connector

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

 

1. Connection of the devices

Kleenpak® Presto Sterile Connector

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

Kleenpak® Presto Sterile Connector

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

 

3. Actuation

Kleenpak® Presto Sterile Connector

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.

Document

Datasheet

  • Kleenpak® Presto Sterile Connector

    Select Language :

Specifications

 

Materials of Construction

 
Product Contact Parts Material of Construction
Connector body Polyethersulfone (PES)
O-ring Platinum-cured silicone

 

Product Non-Contact Parts Material of Construction
Protective cap Thermoplastic elastomer
Cover and tab Polybutylene terephthalate (PBT)

 

Extractables Matrix (NVR)

 

Post Irradiation and Autoclave

 

  Time 0 (≤ 30 Mins) 24 Hours 7 Days
Test Order
Solvent Temperature Ambient (25 ºC) 40 ºC 40 ºC
1 50% Ethanol Yes
Yes Yes
2 0.5 N NaOH Yes Yes Yes
3 0.1 M Phosphoric Acid Yes Yes Yes
4 1% PS-80 Yes Yes Yes
5 5 M NaCl Yes Yes Yes
6 WFI or Deionized Water Yes Yes Yes

Extractables results available on request. Please contact Pall.

 

 

Sterilization Specifications

 

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

 

Operating Specifications

 

Parameter Value
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

 

Nominal Dimensions

 

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 33 g 33 g 34 g 36 g 36 g 41 g

Additional Information