Sterility testing is a critical step performed before the lot release of sterile parenteral pharmaceuticals, ophthalmic products, and medical devices. It is designed to determine the presence or absence of viable contamination microorganisms in sterile products. Products are filtered through a membrane enclosed within a canister, rinsed, filled with a suitable growth medium, incubated for 14 days, and checked for microbial growth. During this testing process, it is vital to ensure a complete aseptic technique to avoid false positive results, which can delay product release and require additional resources to investigate the root cause of the contamination source.

Sartorius has supplied membrane filtration systems for several decades and has continually updated and improved its offerings. Here, we gain insights from Eric Arakel who heads the product management team for microbiological testing on their most recent innovation—the Sterisart^® Universal | Gen 4—what makes it different and why it should be a vital piece of equipment in any lab that needs to optimise sterility testing.

Q: What exactly is the Sterisart^® Universal | Gen 4?
Eric: It's a next-generation peristaltic pump designed for closed membrane filtration-based sterility testing. Its small, compact size makes it ideal for use in laminar flow cabinets, clean rooms, and isolators. Its mirror-finish 316L stainless steel construction ensures superior cleanability, meeting strict decontamination standards.

Q: So, the pump is paired with a membrane filter?
Eric: Correct! A membrane filter within a closed single-use system - the Sterisart^® sterility testing canisters. We offer an exhaustive range of canisters incorporating a series of innovative features such as an aseptic sampling port and a patented, easy-to-use needle design ensuring consistent, ergonomic operation. But let's circle back to that another time.

Q: Is there a single model, or are there different pump variants available?
Eric: The pump is available in three versions: Basic, Essential, and Advanced. These versions replace the previous generation, namely the 16419 and 16420.

Q: Who is the Sterisart^® Universal | Gen 4 targeted at?
Eric: It is built for use in microbiological QC testing labs within the pharmaceutical industry, including contract testing services. It caters to the needs of lab managers, sterility test operators/technicians, and validation experts.

Q: What sets it apart from other similar devices available on the market?
Eric: Sartorius has been a leading presence in the field of sterility testing for decades and we have listened to the feedback from our extensive global customer base. As a result, this next-generation pump eliminates a lot of pain points in both system operation and data handling.

Some of the new features include:

• It features an integrated barcode scanner, streamlining data entry and ensuring accuracy.
• It supports comprehensive electronic documentation and SOP (Standard Operating Procedure) creation, enhancing efficiency.
• Aligns with 21 CFR Part 11/Annex 11 requirements, ensuring adherence to regulatory standards and facilitating regulatory compliance such as data integrity.
• A universal, open, hygienic, modular and ergonomic design.

Q: Can you provide more detail on the last point regarding the product's design?

Eric: Certainly,

• Universal: Developed both for benchtop use and with the capability to integrate into isolators.
• Open: Our system is compatible with most sterility testing canisters available on the market
• Modular: Allows upward upgradability to new requirements with a reduced ecological footprint.
• Hygienic: Constructed from 316L grade stainless steel to enable cleaning with commonly used sterilants. It is fully compatible for use with corrosive Vaporized Hydrogen Peroxide (VHP). It also features easily detachable components to facilitate thorough cleaning procedures.
• Ergonomic: We've prioritised comfort and usability to reduce user fatigue knowing that tests are performed in constrained spaces.

Q: How can it improve the sterility testing workflow?

Eric:

• The pump records all user interactions, facilitating transparency and traceability.
• By documenting user interactions, the pump enables the creation of SOPs and allows for semi-automation through a workflow configurator.
• The pump provides visual guidance through each stage of the sterility test, step by step..

Q: Is it suitable for globally located sites? How many languages does it support?
Eric: Absolutely! It supports 10 languages - English, French, German, Portuguese, Spanish, Italian, Russian, Chinese, Japanese and Korean

Q: Can you share a real-life example of a lab that has upgraded to this new system? How has it improved its sterility testing (higher throughput, lower false positives)?
Eric: We have worked closely with several early adopters throughout the development phase, and interest has been significant.

Paper-based documentation is often tedious and prone to errors. For example, manually recording material data of reagents and consumables used during sterility tests is cumbersome. Operators typically need to withdraw their hands from isolators to document critical parameters, which impacts throughput.

Additionally, creating Standard Operating Procedures (SOPs) requires exhaustive documentation of each workflow step during the method feasibility and validation phases. These processes are now streamlined and error-free with our integrated barcode scanner and record feature on the pump, which automatically documents every user interaction with the pump in a comprehensive electronic report.

Needless to say, paper-based documentation also demands considerable filing time and storage space. Retrieving records during an audit can be particularly time-consuming. In contrast, we now offer customers the ability to access their records with just a few keystrokes, saving time, costs, and effort.

Q: What is needed for a lab to upgrade or to implement as a new system? What support can Sartorius offer for this?
Eric: Customers can take advantage of our service support, which includes Installation Qualification (IQ) and Operational Qualification (OQ) services, as well as an annual maintenance contract. Our product specialists are also available to assist with any queries during the initial setup.

The pump is designed to fit into any standard round cutout in any isolator, eliminating the need for a refit. It is backward compatible with previous generations of the Sterisart^® pump and compatible with other pumps on the market.

• Watch the product video to learn more.
• Read more about the Sterisart® Universal | Gen 4 here.
• Download the Sterisart® Universal Pump | Gen 4 White Paper here.

About Eric Arakel

Eric Clement Arakel heads the product management team for microbiological testing at Sartorius. Eric is a Molecular Biologist by training and has been with Sartorius for over 5 years supporting customers in their Sterility testing and Environmental Monitoring needs.