Kleenpak® Presto Sterile Connector

 

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

 

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

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.

 

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 data to BPOG guidelines 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