Sterility testing is used to ensure the absence of contaminants in biologics and medical devices. Sterility testing pumps are used for sterility testing in clean room benchtops, laminar flow hoods, isolators and clean rooms. They usually consist of a bottle holder, drain tray, communication hub (consisting of USB port, fuse holder, ethernet and communication ports etc.), and a user interface. The test units are optimised for open and closed containers. The closed system is used for the sterility testing of pharmaceutical products. The system is based on the membrane filter method. By this means the main risk of a secondary contamination and false positive results is eliminated. Currently available products in the market are Steritest Symbio Pump (Merck), Sterisart Sterility testing pumps (Sartorius) and HTY-APL01, HTY-APL02, HTY-APL01ISO, HTY-APL02ISO, HTY-2000B, HTY-601 (Hangzhou Tailin Bioengineering Equipments),LT-STP-08 (Lotus tech) etc. Steritest Symbio Pumps were launched in August 2014 by Merck Millipore. Sterility testing pumps by Tailin Bioengineering received CE approval in April 2014.
Nearly all kinds of products can be tested with the system, including Large-volume parenteral solutions and small-volume parenteral solutions in plastic or glass bottles, ampoules, collapsible bags, and vials, Pre-filled syringes, Lyophilized and other soluble products in ampoules or vials, Antibiotics in ampoules or vials, Medical devices and Difficult-to-dissolve powders etc.
The global sterility testing pumps market is segmented on the basis of area of use, types of products to be tested and geography. Area of use segment is further sub-segmented into Laminar flow hood (LFH version), Isolator (ISL version), and Multiple configurations (Universal) version. Multiple configurations version is expected to grow in future since it can be adjusted in both isolator and laminar flow hood setting. Also, this version can be used with other types of pumps. Types of products segment can be divided into following types: Microbiology products, where peristaltic pumps are used for sample and media transfer and pharmaceutical products, for which a completely closed system is used for sterility testing or reusable sterility test systems are used for the sterility testing of injection and infusion solutions. Pharmaceutical products segment is expected to hold a major share. As the therapeutic segment oncology and biologics have major focus of the pharmaceutical industries, sterile injectables have become a larger component in pharmaceutical industry’s pipeline, making sterility testing a primary and stringent requirement.
Geographically market is further segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America holds the largest revenue share mainly due to factors such as presence of key pharmaceutical and biotechnology industries involved in active research and development activities, presence of a proactive healthcare system requiring stringent control on quality of drug formulation and strict guidelines by the USFDA regarding environmental monitoring and product qualities in pharmaceutical industries. For Europian Union, Germany is the major contributor in this market owing to the fact that two major players in the market viz. Merck and Sartorius are headqurtered in the country. The Asian market will witness growth primarily due to the increasing expenditure on life science research in the region and growing trend of pharmaceutical outsourcing to Asian countries like India and China, also, Tailin Bioengineering equipments from China being one of the promising sterility testing pump manufacturer.
The market will be driven by increased number of pharmaceutical and biotechnology companies, increased number of newer drugs and formulations, increasing R&D in life sciences and increasing government support.
Market players leading in sterility testing pump manufacturing are Sartorius, Merck, Lotus Tech and Hangzhou Tailin Bioengineering Equipments with strong suppliers in the market like Trafalgar scientific (Sartorius), Fisher scientific (Sartorius) etc.