Sterility Testing Pump: Sterisart® Universal | Gen 4

In the highly regulated pharmaceutical and biotechnology industries, maintaining sterility is a fundamental requirement. Sterile products destined for patient use must consistently meet stringent quality and safety standards. Barrier technologies, including isolators and cleanrooms, are critical in creating aseptic environments where the risk of contamination is minimized. However, the complexity of these technologies necessitates sophisticated tools that are both user-friendly and efficient. 

The Sterisart® Universal | Gen 4 pump is engineered for seamless operation within barrier technology environments, offering precise and contamination-free transfer of samples and media into Sterisart® canisters for sterility testing. The integration of cutting-edge hardware with intuitive software facilitates product safety and compliance, with flexible connectivity, remote-enabled operation, enhanced user interface, and paper-free reporting software built for 21 CFR part 11.

Introducing: Sterisart®️ Universal Pump | Gen 4 for Sterility Testing 

Experience our new pump designed to meet all your quality and safety needs in sterility testing with paperless documentation, 21 CFR Part 11 compliance, and flexible connectivity.

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Product Comparison

Sterisart® Universal | Gen 4

Basic

Essential

Advanced

Article Number

16421-B

16421-E

16421-A

Hardware

Sterility testing pump

 

 

 

Display

 

 

Software

Remote operation

 

Workflow configuration

 

Simple report

 

 

Extended report

 

21 CFR Part 11 conformity

 


Sterisart® Sterility Testing Canisters

The Sterisart® System, a single-use membrane filtration device for pharmaceutical sterility testing, offers over 20 types for tailored applications.

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Sterisart® Universal Pump Features

Sterisart Universal Sterility Testing Pump Support Rod product image
Sterisart Universal Sterility Testing Pump Support Rod product image
Product image - Sterility Testing Lab Pump Sterisart in Skan Spectra Isolator - Close Right
Sterisart Universal Sterility Testing Pump Drain Container product image
Sterisart Universal Pump Reporting CFR Part 11 Compliance - shown on laptop screen
Reliable
  • 316L grade mirror finish stainless steel
  • Fail-safe locking mechanism
  • Equal splitting of sample volumes
  • Compatible with VHP and common sterilants
  • Real-time pressure sensor
Flexible
  • One universal pump for all environments
  • Modular design
  • Compatible with most sterility testing canisters
User-Friendly
  • Compact footprint
  • 7-inch touchscreen display with integrated barcode scanner
  • Visual guidance of the workflow
  • Choice of multiple languages: English, French, German, Portuguese, Spanish, Italian Russian, Chinese, Japanese, and Korean
Compliant

Advanced electronic reporting software built for 21 CFR part 11

Related Resources

Videos

Sterisart®️ Universal Pump | Gen 4 Teaser Video

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Sterisart®️ Universal Pump | Gen 4 Unboxing & Integration Video

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Product Resources

eBook

Sterility Testing Playbook

This interactive PDF/playbook helps you to easily identify the right sterility testing canister for your application. The playbook also provides an ov...

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Flyer

Sterisart®️ Universal | Gen 4 - A Universal Pump for Any Space

Where Convenience Meets Compliance

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Data

Product Datasheet - Sterisart®️ Universal | Gen 4 

Where Convenience Meets Compliance

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Brochure

Sterility Testing for a Connected Era - Sterisart®️ Universal | Gen 4

Where Convenience Meets Compliance

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Featured Resources

Flyer

Sterisart® Sterility Testing

PDF | 349.7 KB

Product Datasheet

Sterisart® Family - Consumables for Sterility Testing

PDF | 1.3 MB
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Service Support for the Sterisart® Universal | Gen 4

From installation to regular maintenance, our team ensures smooth setup, IQ/OQ, sensor calibration, and proactive preventive maintenance to secure the operations of your equipment.

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Frequently Asked Questions

Peristaltic pumps operate using a tubing system that transfers a test sample into a closed container, without coming into direct contact with its components, ensuring the integrity of the sterility testing process. Besides ensuring equal splitting of sample volumes, it offers precise control over flow rates and eliminates the generation of particles and aerosols, safeguarding both the process and the operator.

Several considerations should be taken into account to ensure its suitability

  • The design must prioritize contamination control, featuring easy disassembly for thorough cleanability and compatibility with a broad range of sterilants, including Vaporised Hydrogen Peroxide (VHP). 
  • The pump should have a low profile since space is of a premium in closed confined spaces such as isolators, laminar flow hoods (LFH) and Biological safety cabinets (BSCs).
  • Precision in equal volume splitting and flow rate control is key for achieving accurate and reproducible results. 
  • The pump's design should prioritize easy maintenance and robustness to minimize downtime, incorporating fail-safe mechanisms for enhanced reliability. 
  • An open design is preferred to ensure operational continuity, aligning with the best practice of validating a second supplier.
  • In alignment with the digital era, choose a pump that supports electronic reporting, ensuring future-proof capabilities for evolving process automation needs. This covers features like material data capture, versatile connectivity options, and synchronization capabilities.
  • Crucially, verify that the chosen pump complies with relevant regulatory standards for both sterility testing and electronic records maintenance, including adherence to standards like 21 CFR Part 11 and Annex 11.

Compliance with 21 CFR Part 11 and EU Annex 11 is crucial as these regulations set standards for electronic records and signatures in the pharmaceutical and life sciences industries. Adhering to these requirements ensures the integrity, reliability, and security of electronic data, promoting transparency, traceability, and regulatory adherence in critical processes such as sterility testing. 

Non-compliance may lead to regulatory sanctions and organizations can be faced with warning letters from regulatory authorities and potentially a market recall. Ensuring compliance is not only a regulatory requirement but also a strategic approach to maintaining operational excellence and industry credibility.

Best practice recommends that users should utilize manufacturer services, including Instrument Qualification (IQ) and Operational Qualification (OQ), to ensure the proper functioning and compliance with regulatory standards. It is advisable to conduct requalification or include an annex to the IQ/OQ binder when implementing device upgrades.

  • Conduct routine visual inspections to detect signs of wear, damage, or contamination. 
  • Promptly replace worn parts following recommended intervals for part replacement. 
  • Implement a structured cleaning schedule, thoroughly cleaning accessible surfaces using approved sterilants and adhering to decontamination guidelines provided by the isolator manufacturer.
  • Periodically verify and recalibrate sensors on the pump (such as the pressure sensor) for accuracy, a service typically offered by the manufacturer. 
  • Best practice advocates for a bi-annual service interval, with an annual frequency as the minimum recommendation. 
  • Maintain detailed records of qualification, maintenance, calibration, and cleaning activities.
  • Adhere strictly to manufacturer guidelines.
  • Restricting access to the device and ensure that all personnel operating the pump are adequately trained. 
  • Take measures to minimize spillage and exposure to factors that may impact its performance.

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