Pharmaceutical Autoclaves - 16 Pages

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Pharmaceutical Autoclaves
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Catalog excerpts

Your Sterilization & Infection Control Partners Pharmaceutical Autoclaves

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Pharmaceutical Autoclaves Tuttnauer pharmaceutical autoclaves have been engineered and manufactured in compliance with the cGMP regulations to meet the technical challenges of the pharmaceutical and biotech industries. Your products will be reliably and consistently sterilized according to the highest international standards with every cycle when using a Tuttnauer pharmaceutical autoclave. Tuttnauer provides high quality & safe autoclaves made from reliable long lasting components, and designed to conform to end-user requirements (URS) for production and quality assurance processes. For over 87...

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Pharma Line Adherence to the cGMP Guidance Specification, Documentation & Acceptance Testing In general, Tuttnauer adheres to the cGMP in order to satisfy your requirements for documentation and qualification of pharmaceutical autoclaves. In order to give our customers the confidence that they are using safe high quality cGMP pharmaceutical autoclaves, Tuttnauer comprehensively documents the design specifications, components, software, manufacturing process, and acceptance testing in order to prove that the autoclaves meet the customer’s requirements. GAMP In order to ensure quality manufacturing,...

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Production Sterile Processing Bulk capacity autoclaves are ideal for pharmaceutical and biotech production lines where they are easily integrated with cleaning and sterilization systems used in pharmaceutical production. Tuttnauer autoclave sterilization cycles will preserve the integrity of your products, packaging and instruments, while killing all micro-organisms. The pharmaceutical autoclaves have been developed to be used for many common applications in the pharmaceutical industry Pharmaceutical Production Facility Preparation Area A1. Tuttnauer Autoclave A2. Tuttnauer Autoclave Production...

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Pharma Line QA Laboratory Sterile Processing Tuttnauer's small capacity autoclaves are well suited for R&D departments and QA laboratories where they integrate with quality management processes and conform with QA policies that required accurate monitoring and documentation, and precise control. Pharmaceutical Quality Assurance Facility Preparation Area 1. Laboratory Washer Disinfector A1. Tuttnauer Autoclave A2. Tuttnauer Autoclave Sterile Area 2. Laminar Hood Supporting Products for Production and QA Tuttnauer also provides: • Steam generators • Clean steam generators Loading Equipment: • Pull-out...

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Design and Construction The pharmaceutical autoclave line is designed and constructed for sanitary pharmaceutical applications which require strict compliance with cGMP. All machine components exposed to steam are made from 316L stainless steel. Diaphragm Valves Specialized Piping Diaphragm valves and gauges are used to allow maximal drainability and minimise the risk of contamination. To meet the high sanitary requirements of the cGMP the pharmaceutical-grade sanitary line (primary piping) to the chamber steam inlet is orbital welded. Sanitary Air Filter A 0.2 μm air filter ensures that bacteria...

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Pharma Line Chamber and Jacket Construction The 316L Stainless Steal chamber inner walls have a mirror like surface level polish less than 0.4 μm (specific polishing values are available upon request). The chamber is constructed to be drainable with smooth, rounded and sloped surfaces to enable proper drainage and cleaning. The jacket is constructed from 316L stainless steel. The chamber is cooled through jacket water cooling.

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Advanced Control System Take advantage of Tuttnauer’s sophisticated user-friendly PLC control system based on the advanced Allen-Bradley platform in all pharmaceutical autoclaves. Standard Features • 7" Multi-color touch screen for easy access to controls and information via the panel • Stores the last 200 cycles in built-in memory • 4 access levels and 11 user passwords to control access/operation of the autoclave • In/Out test (enables technician to check each system component separately) • Sterilization Temperature range 110°C to 137°C • Ethernet connection for remote monitoring, remote maintenance,...

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Pharma Line Standard Optional Ethernet Network Independent Supervisory System Standard Printer Barcode Touch Screen 2 (for two doors) Touch Screen Chart Recorder External remote access for technical support SCADA Software & Hardware SCADA software (optional) allows for control and monitoring of up to 16 sterilizers on an external PC. The software retrieves data, creates graphs, tables and printouts. Thousands of hours of cycle data can be stored in the cycle history.

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Programs The advanced control system allows for customization of each program which allows for a high degree of versatility, providing the flexibility of using the same autoclave for many types of loads and applications. The controller has up to 22 programs. Tuttnauer thoroughly checks each program to ensure that they perform according to our customers requirements (URS). Unwrapped & Solid • Utensils • Glassware • Machine Parts Wrapped & Porous Goods • Textiles • Filters & Filter Vessels • Elastomers & Rubbers • Ampoules & Vials • Instruments & parts (wrapped) • Glassware (Wrapped) Liquids & Media...

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With the pre and post vacuum optional feature the following additional benefits are available: Liquid Sterilization and Media Preparation • Efficient forced air removal for media and liquids • Water cooling in the jacket to reduce cooling times (chamber is pressurized with compressed air to prevent liquid loss) Dry Goods and Porous Loads • Adjustable vacuum and pressure rates, depth, and holding time in both pre and post conditioning phases for fast and efficient processing & preservation of product • Suitable for items such as empty containers, filters and tubing

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Control &Documentation Features and Options Standard ü Validation and Support Documentation IQ/OQ Documentation (cGMP) Software Sequence of Operation (SOO) Independent Recorder 10” Touch Screen (7” standard) External Printer

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