Product Datasheet Sterisart  Family Sterility Testing Made Easy and Reliable Benefits Compact, ergonomic design to cover all standard sterility testing applications Specially engineered needles for safe and easy piercing of stoppers and containers Anti-foaming inlet Raised sterile venting Tethered, large, grip-optimized filter caps Septum port that guarantees aseptic sampling and supplementation Recess in packaging that houses directly accessible outlet plugs Product Information The development and manufacturing of injectable, sterile medical products under GMP conditions is one of the most challenging and sensitive issues in the (bio-)pharmaceutical industry. Before a batch of the parenterals concerned can be released by the quality control department (QC), proof of sterility must be provided by performing the sterility test according to USP <71>, Ph. Eur. 2.6.1 and JP 4.06.

International Guidelines and Requirements Quality Control According to international pharmacopeias, parenterals (such as vaccines, mAbs, intravenous infusions, antibiotics, diabetes medication) that are injected into the human or animal body are subject to sterility testing. However, other products must be tested for sterility as well, for example: Ophthalmics Immunodiagnostics (urine | blood, etc.) Intermediates | APIs Cell culture media Cell banks Virus banks Medical instruments (e.g., scalpels) Ointments Creams As Sartorius is a recognized supplier of products and services for the pharmaceutical...

Technical Specifications Basic Structure of Sterisart ® RC Units with a Regenerated Cellulose Membrane Standard configuration, order no. ending in GBD Configuration with septum, order no. ending in GSD Sample Type Product Container Order Number Closed glass bottles with a septum Closed glass bottles with a septum LVPs, SVPs Open containers e.g. glass ampoules, glass bottles, collapsible plastic bags According to the United States Pharmacopeia: *LVPs: Large Volume Parenterals > 100 mL *SVPs: Small Volume Parenterals < 100

Basic Structure of Sterisart® RC Units with a Regenerated Cellulose Membrane Sample Type Product Container LVPs, SVPs Open containers e.g. glass ampoules, glass bottles, collapsible plastic bags Prefilled syringes with or without a spike Prefilled syringes with or without a spike Lyophilisates, soluble powders, liquid antibiotics Closed glass bottles with a septum Lyophilisates, soluble powders, liquid antibiotics Closed glass bottles with a septum Closed glass bottles with a septum Closed glass bottles with a septum According to the United States Pharmacopeia: *LVPs: Large Volume Parenterals...

Basic Structure of Sterisart ® RC Units with a Regenerated Cellulose Membrane Sample Type Product Container Order Number LVPs, SVPs, eye drops Closed containers; plastic containers with blow-fill seals; e.g. bottles, ampoules One-connector system for testing tube assemblies and bags. Fits product containers with male Luer lock or female Luer slip connectors Two-connector system for testing product containers with a male Luer lock; double-needle spike for simultaneous transfer of rinsing liquid According to the United States Pharmacopeia: *LVPs: Large Volume Parenterals > 100 mL *SVPs: Small Volume...

Standard configuration, order no. ending in GBD Basic Structure of Sterisart® CA Units with a Cellulose Acetate Membrane Sample Type Product Container Closed glass bottles with septum LVPs, SVPs Open containers; e.g., glass ampoules, glass bottles, collapsible plastic bags According to the United States Pharmacopeia: *LVPs: Large Volume Parenterals > 100 mL *SVPs: Small Volume Parenterals < 100 mL

Products for Direct Aseptic Transfer of Liquid Samples to Each Required Culture Medium Sample Type Product Container Order Number Liquids difficult to filter; medical materials Closed glass bottles with a septum Liquids difficult to filter; medical materials Closed glass bottles with a septum | open glass bottles Sample Preparation Sample Type Product Container Powder with low solubility in closed glass bottles with a septum Tube assembly with metal double needles of two different lengths Optional Accessories Sample Type Product Container Sterile venting of containers filled with rinsing solutions...

Applications Applications for Different Membranes and Systems Overview of the Sterisart ® Systems Sterisart ® RC with a regenerated cellulose membrane is particularly suitable for testing aggressive, aqueous products and antibiotics. Sterisart ® CA with a cellulose acetate membrane has been specially designed to analyze the sterility of difficult-to-filter, viscous substances, such as emulsions, using membrane filtration. Transfer sets: If the membrane filtration method cannot be used for sterility testing of liquid products, the Sartorius sterile transfer sets can be used for aseptic transfer...

Sterisart ® Universal Pumps for Transfer of Liquids to the Sterisart ® Units 16420 with a display and an integrated barcode scanner 16419 Basic version Order number Order number Sterisart Easy Configuration Software Drag & drop software, designed to increase process reliability for sterility testing Stainless steel cover for the rotor External barcode scanner Drainage container cover for competitor’s sterility test consumables Adapter for Sterisart ® systems in Equinox pumps; pkg. of 2 Drainage container for Sterisart ® pump 16419 | 16420 Drainage container cover for Sterisart ® sterility test...

General Technical System Details and Regulatory Requirements The Sterisart ® systems comply with GMP requirements with respect to sterility testing as well as to Regulation (EC) No. 1907/2006 (REACH) with particular reference to the plasticizer DEHP; ED/108/2014, ED/ 67/2008. Sterilization Gamma-sterilized at 25 kGy in compliance with DIN EN 552 and ISO 11137 Sterilization indicator on each carton; color change: from orange to red Shelf Life Gamma-sterilized units: Sterile for up to 3 years after the date of manufacture; guaranteed for a minimum of 6 months after delivery Dimensions and Weight...