History of Sterility Testing

History of Sterility Testing

This article will be about the history of sterility testing.

Way back in 1927, Sartorius manufactured membrane filters which for the very first time made the sterilization of heat-sensitive solutions entirely possible. These membranes have now been continually enhanced for a wide range of applications and remain at the core for sterility testing. Back in the late 1960s, identifying a serious need to ensure that pharmaceuticals are free of microbial contamination, Sartorius teamed up with scientific institutes and the German pharmaceutical industry to develop the right methods and tools for sterility testing. Besides sterilizing grade membranes, Sartorius developed membrane filters for usage in the different predecessors of the modern day single-use sterility test system. The “Schiller system” as it was known in Europe, was a part of the Sartorius portfolio and was also the first closed, reusable sterility test that was used across Europe in the 1970s. to learn much more about the history of sterility testing, read on!

Sterility Testing Canisters

Sterisart NF Systems are state-of-the-art closed filtration systems for lot-release sterility testing of sterile pharmaceuticals. The Sterisart NF system is simple to use and ensures the maximum reliability of your sterility test results. Some of the important features and key benefits include:

  • Covers all standard sterility testing applications
  • Compact, ergonomic, closed design
  • Specially constructed needles for easy and safe piercing
  • Guaranteed sterile barrier for aseptic septum sampling
  • Gas-impermeable, color and also bar-coded packaging
  • Adapters for usage of the Sterisart NF system in all of the pumps
  • Meticulously controlled quality testing

Quality Assurance

Routine testing of each lot includes:

  • Incoming Materials Testing: qualification of the membrane filters, tubing, and plastic
  • Rigorous In-Process Controls: physical integrity test of the housing container, venting filter, and tubing
  • Stringent Final Release Testing: Includes a physical integrity test, bacterial challenge test and also growth promotion test

A quality assurance certificate is delivered with each unit for your records. A comprehensive validation or qualification guide is also available on request.

Sterility Testing Pumps

The Sterisart Universal Pump, could be used within isolators, laminar flow hoods, biosafety cabinets or cleanroom benches. Since space is usually at a premium, the pump features a compact architecture with a space-saving type of footprint. We have designed our pump focused on your convenience. Mixed with our Sterisart sterility testing canister, we can offer complete confidence within sterility test results. The testing pump has versatile pump designed for bench-top use or integration into an isolator, as well as it being compact and low-profile for comfortable use.


Lab People Inc. is a trusted provider of laboratory equipment, services, supplies, and rental equipment for you and your laboratory. As an ISO 17025 accredited service organization, we stand behind our services with 100% satisfaction guaranteed for all our customers. We offer on-site and off-site calibration services for balances, pipettes, moisture analyzers, force measurement, test weights, and more. Services include preventative maintenance, SQ-Min, IQOQ, repairs, legal for trace/placed in service, verification, and more.

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This entry was posted on Friday, March 17th, 2023 at 12:24 pm. Both comments and pings are currently closed.

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