Sterile production facilities are currently being newly established or ramped up with breathtaking urgency and speed. In such times, it is particularly important that your supplier of sterility testing solutions can offer the expertise, experience, and breadth of products and services needed to devise, deliver, and implement the perfect set-up for your facility, no matter what the settings and circumstances are. As a pioneer of sterility testing by membrane filtration since introducing the Steritest™ system to the market in 1975, we have permanently expanded and perfected our portfolio of filtration devices, culture media & rinsing fluids, pumps, accessories, and services to become a one-stop-shop for sterility testing in pharmaceutical manufacturing. Well thought out device features with attention to detail and a straightforward six-step workflow ensure regulatory compliant and reliable results every time, whether you are testing in a cleanroom, laminar flow hood, biosafety cabinet or isolator.
We offer all necessary components for fully compliant testing according to USP <71>, EU Pharmacopoeia <2.6.1> and JP Pharmacopoeia <4.06>, the key ones being:
Steritest™ NEO Devices: The filtration membranes are thermo sealed onto the base of the units for full integrity of the device and efficient membrane rinsing, while eliminating the risk of by-pass. The ease and convenience of these closed Gamma-sterilized, single or double-packed assemblies increase productivity while maintaining the highest levels of quality and reliability. Available for liquids, soluble powders, creams, and ointments, to be filled into any types of containers such as ampoules, collapsible bags, vials, syringes, or cartridges.
Culture Media & Rinsing Fluids: Manufactured in an ISO 9001, environmentally controlled production center, each lot undergoes a stringent quality control (QC) procedure, including pH, sterility, and growth promotion testing according to USP, EP, and JP methods. Available in multiple configurations and volumes, Gamma-sterilized & double-packed, and with barcodes to ensure traceability.
Steritest™ Symbio Pumps: Complemented by a comprehensive range of smart accessories, these ergonomic, user-friendly pumps can be perfectly integrated into any testing environment. There are several pump variants, depending on where and how they are to be installed and on the available space. A display gives step-by-step online guidance. The dedicated Steritest™ Symbio Software helps to easily create and manage test methods and simplifies synchronization.
Steritest™ Services: We offer a comprehensive portfolio of services to support the Steritest™ family, including method development, validation protocols, validation services, maintenance & service plans, and training—all to reduce your sterility testing workload, so you can focus on critical activities.