Cytiva List of Products and Services

"CleanPack(TM) Nova" is a disposable filter for pilot-scale and process-scale production of biopharmaceuticals, biological pharmaceuticals, diagnostic drugs, culture media, and eye drops. It incorporates standard cartridge filters of 10 to 30 inches, which were traditionally mounted in stainless steel housings, into capsule-type plastic housings. We offer a wide range of cartridges for various media, including sterilization filters and virus removal filters. 【Features】 ■ Selection from a rich variety of media and grades ■ Significant cost reduction by minimizing cleaning and validation ■ Easy transition from stainless steel products ■ Improved operational safety ■ Sterilized products are also available *For more details, please refer to the PDF document or feel free to contact us.

The "Palltronic AquaWIT IV" is a system developed to perform extremely important integrity tests accurately, reproducibly, and reliably. It involves filling the housing of a hydrophobic filter with water, conducting a water intrusion test, and draining the housing. It features a sanitary design with a removable internal water tank. 【Features】 ■ Fully automated pre-test operations and integrity test cycles for hydrophobic filters ■ Fully automated wetting and testing sequences for hydrophilic filters ■ Automatic control of critical parameters that affect the results of the water intrusion test ■ Designed for use in a GMP environment compliant with electronic record and electronic signature regulations (21 CFR Part 11) *For more details, please refer to the PDF document or feel free to contact us.

The "Enfron® HTPFR Filter Cartridge" is designed for the filtration sterilization of high-temperature gases used in the fields of pharmaceutical manufacturing and biopharmaceutical manufacturing, as well as for tank venting of vented and ozone-treated water, and for filtration sterilization of high-concentration oxygen air. It includes a dual-layer hydrophobic polytetrafluoroethylene (PTFE) membrane manufactured by Paul, which possesses antioxidant properties, and the materials used in the cartridge can be utilized for long-term gas filtration applications up to 100°C. 【Features】 ■ Water intrusion testing is possible ■ Uses PTFE membrane uniquely manufactured by Paul ■ Made with materials that have excellent oxidation resistance ■ Challenges B. diminuta at >10^7 cfu/cm2 and obtains validation data *For more details, please refer to the PDF document or feel free to contact us.

Are you worried that introducing single-use technology will increase manual operations and lead to more human errors? Even with single-use equipment, full automation can be achieved just like with traditional stainless steel lines, and it's easy to do. In traditional automation systems for stainless steel piping and tanks, SIP and CIP were necessary, resulting in a vast number of valves and pipes, making it impossible to realize an automated process without constructing complex sequences. However, with automation systems for single-use processes, SIP and CIP are eliminated, allowing for automation through simple automatic sequences. With the Allegro MVP single-use automation system, sequences can be developed simply by inputting the parameters of unit processes and stacking them up. This enables customers to easily develop sequences on their own. Multiple sequences can be set up. Operators can select the sequence according to the process they are performing, and by simply pressing the Start button, the automated process begins. This eliminates human errors such as mistakenly opening clamps. *For more details, please download the PDF or feel free to contact us.

Enfron® PFR is a hydrophobic filter with sterilizing grade (0.2μm) that achieves high flow characteristics and long filtration life. It demonstrates excellent durability for the filtration and sterilization of pressurized air, various vent applications, and repeated steam sterilization. 【Main Features】 ■ Validated as a sterilizing grade filter through a bacterial challenge test using B. diminuta (ATCC19146) at a concentration of 1x10^7 cfu/square centimeter or more. ■ Also validated through challenge tests using aerosolized B. diminuta and PP7 bacteriophage (25 nm). ■ Improved reverse pressure strength of the filter cartridge during in-line steam sterilization (SIP) to 0.05 MPa (125°C). ■ Integrity tests that correlate with sterilization performance are possible (forward flow test, pressure hold test, water intrusion test).

Do you have any of these concerns? With the increase in the number of manufactured items leading to higher operational rates, and the need to accommodate the expansion of manufacturing lines and diversifying modalities, isn't the type and quantity of buffers required on the rise? The labor required to prepare, store, transport to the process room, and supply buffers to tanks can be reduced. "Innovation in Buffer Supply for Biopharmaceutical Manufacturing" By diluting the necessary amount of buffer inline when needed, buffer preparation can achieve labor savings and space reduction (up to 75%). Furthermore, an increase in productivity per area can be expected!

The Palltronic® Flowstar V is a filter integrity testing device that meets the latest regulatory requirements and can perform reliable integrity tests in the filtration sterilization processes of pharmaceutical manufacturing, where sterility assurance is necessary. Developed based on years of experience and extensive expertise, it retains the features of the previous model while being even more user-friendly, with enhanced data integrity and quality risk management functions. [Compliance with Data Integrity and 21 CFR Part 11 Requirements] It is equipped with performance that complies with guidelines on data integrity and electronic signature security from 21 CFR Part 11 and the UK Medicines and Healthcare products Regulatory Agency (MHRA), addressing each requirement. Therefore, it demonstrates reliable performance in the filtration sterilization processes of pharmaceutical manufacturing, where sterility assurance is required.