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Pharmaceutical Autoclaves for Pharmaceutical Production

Pharmaceutical Autoclaves for Pharmaceutical Production
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Pharmaceutical Autoclaves for Pharmaceutical Production

Product catalog summary
Overview
Tuttnauer pharmaceutical autoclaves are designed for the pharma and biotech industries, adhering to cGMP regulations. They offer precise control for sterile processing and pasteurization, with over 350,000 installations worldwide.
Customization and Innovation
With 90 years of experience, Tuttnauer customizes autoclaves to meet specific customer requirements, including layout limitations and optimal chamber loading design.
Manufacturing and Quality Assurance
Utilizing advanced manufacturing techniques like laser cutting and robotic welding, Tuttnauer ensures precision and reliability. Autoclaves feature robust ASME and PED compliant chambers, with sophisticated Allen-Bradley control systems for precise operation.
Applications
Autoclaves are used for pre-production sterilization, terminal sterilization, R&D, QC applications, and biohazard waste sterilization. They support various sterilization methods, including over-pressure, gravity displacement, and pre-vacuum cycles.
Support and Documentation
Tuttnauer provides comprehensive support from pre-sales to post-delivery, including installation and validation. Documentation includes URS, DQ, IQ, OQ, and FAT/SAT protocols, ensuring compliance with cGMP regulations.
Features and Options
Autoclaves offer a range of features, including stainless steel chambers, advanced control systems, and optional features like SCADA and barcode integration. They support a wide range of applications with customizable cycle programs.
Advanced Control System
The Allen-Bradley control system offers a user-friendly interface with a 7" touch screen, multilingual support, and remote monitoring capabilities. Optional features include a 15" touch screen and real-time piping diagrams.
SCADA Software
Optional SCADA software allows monitoring of up to 10 sterilizers from external PCs, offering data retrieval, graph creation, and storage of cycle and event data in HTML format.
Loading Equipment
Tuttnauer offers customized loading solutions, including automatic loading systems, loading carts, and transfer carriages. These are designed for optimal load placement and ease of use, with features like removable chamber rails and configurable shelves.
Steam Generators
For sites lacking clean steam utilities, Tuttnauer provides built-in and standalone steam generators, available in electrical and steam-to-steam variants, made from 316L stainless steel.
Components and Parts
The autoclaves use standard components from renowned manufacturers, ensuring reliability and ease of maintenance. Tuttnauer supports customers in inventory management and provides a web portal for sourcing components.
Standards and Directives
Tuttnauer autoclaves comply with numerous quality standards (e.g., cGMP, ISO 9001) and directives (e.g., PED, RoHS), as well as technical standards like ASME and IEC for safety and performance.
Safety Features
Safety is prioritized with redundant monitoring systems, audiovisual alarms, and emergency stop buttons. Door safety mechanisms prevent opening under unsafe conditions, and electrical safety is ensured through compliance with IEC standards.
Additional Information
Tuttnauer is a leading manufacturer in sterilization and infection control, with a global presence and a commitment to high-quality products and customer support.
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Catalog excerpts

Pharmaceutical Autoclaves for Pharmaceutical Production-1

Your Sterilization & Infection Control Partners Pharmaceutical Autoclaves Pharmaceutical Autoclaves for Pharmaceutical Production W (^J Pharma Line

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Pharmaceutical Autoclaves for Pharmaceutical Production-2

Pharmaceutical Autoclaves Tuttnauer pharmaceutical autoclaves are designed and manufactured in a state of the art facility in compliance with cGMP regulations to meet the technical challenges of pharma and biotech industries. Tuttnauer autoclaves provide precise control and reliable sterile processing and pasteurization. Tuttnauer is a leading manufacturer of infection control solutions for the Life Science industry with decades of experience and 350,000 installations worldwide including Pharma Facilities, Research Institutes, Laboratories, Hospitals & Clinics. Tuttnauer autoclaves are customized...

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Pharmaceutical Autoclaves for Pharmaceutical Production-3

Pharmaceutical Autoclaves for Pharmaceutical Production Pharma Line Precision Manufacturing & Automation Tuttnauer’s manufacturing process and equipment are constantly updated to be at the forefront of modern automated manufacturing. To ensure uniform manufacturing results and precision-made sterilization equipment Tuttnauer uses high-tech industrial processes including laser cutting, robotic bending, robotic polishing, and automated welding. Our customers receive autoclaves that are robust, reliable and provide precise and consistent results. Inside Every Tuttnauer Autoclave is a Premium Pressure...

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Pharmaceutical Autoclaves for Pharmaceutical Production-4

Autoclave Applications in Pharmaceutical Facilities In the Pharmaceutical/Biopharmaceutical industry Tuttnauer offers a wide range of autoclaves: Over Pressure - Air Steam Mixture & Hot Water Spray • Gravity Displacement • Prevacuum • Biohazard Pre-Production A1. Pure Steam Sterilizer (Hard Loads) A2. Pure Steam Sterilizer (Liquid Loads) 5. Pass-through Window Production & Filling Area 2. Reactor 1 3. Reactor 2 4. Filling Machine T2. Over-Pressure Sterilizer (Bulk Capacity) T1. Pure Steam Sterilizer (Bulk Capacity) B. Biohazard Sterilizer Post-Production 1. Control Stat

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Pharmaceutical Autoclaves for Pharmaceutical Production-5

Pharma Line Pharmaceutical Autoclaves for Pharmaceutical Production Pure Steam Sterilization Pre-production processing involves the sterilization of materials, equipment, containers and other items entering the production floor. Post-production sterilizers are used for terminal sterilization of finished goods. Laboratory applications have a broad scope mainly R&D (product development, manufacturing process development, packaging selection) and Quality Control (QC). Pre & Post Vacuum Pre-vacuum removes air trapped in loads such as garments and hollow loads to achieve effective steam penetration....

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Pharmaceutical Autoclaves for Pharmaceutical Production-6

Support for Your Investment Tuttnauer is dedicated to supporting our customers from pre-sales and installation to production. We understand the time and financial investment made by our customers and provide a team of experienced support managers and expert engineers needed to make your project installation and validation successful. Support is provided throughout every stage of the development, purchase, manufacturing, delivery and installation process. Tuttnauer’s team invests great effort into understanding your requirement specification and transforms it into high-end autoclaves. We provide...

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Pharmaceutical Autoclaves for Pharmaceutical Production-7

Pharmaceutical Autoclaves for Pharmaceutical Production Pharma Line Adherence to the cGMP Regulations Specification, Documentation & Acceptance Testing To ensure that our pharma autoclaves satisfy your requirements we implement a strict documentation and qualification process according to cGMP regulations. This process starts with defining specifications and expectations which will impact every aspect of manufacturing. Deliverable Documentation Our cGMP documentation process is an integral part of each stage of the project management and manufacturing process. The following is a partial list...

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Pharmaceutical Autoclaves for Pharmaceutical Production-8

Chamber and Jacket Construction The inner walls of the 316L stainless steel chamber have a surface level polish less than 0.6 μm [SF6] (specific custom polishing values less than 0.4 μm [SF4] are available upon request). The chamber is constructed to be drainable with smooth, rounded and sloped surfaces to enable proper drainage and cleaning. The chamber is fully jacketed. Sanitary Piping Full sanitary primary piping with tri-clamp connectors, orbital welding and sanitary level components. Tuttnauer sanitary piping is designed and constructed in accordance with cGMP requirements. Our sanitary...

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Pharmaceutical Autoclaves for Pharmaceutical Production-9

Pharmaceutical Autoclaves for Pharmaceutical Production Pharma Line Features and Options Pressure Vessel Standard Optional Piping and Components Primary: Full Sanitary Piping Primary: Simplified Sanitary Piping Secondary: Stainless Steel piping & components with Tri-clamp connectors A wide range of chamber sizes (160 to 17000 liters) are available to meet customer needs. AISI 316L stainless steel chamber AISI 316Ti stainless steel chamber Internal chamber surface polish <0.6 Micro Ra. Internal chamber surface polish up to 0.2 Micro Ra. Electropolish (chambers less than 1300 liters) Jacket: Stainless...

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Pharmaceutical Autoclaves for Pharmaceutical Production-10

Advanced Control System Take advantage of Tuttnauer's sophisticated user-friendly PLC control system based on the advanced Allen-Bradley MicroLogix 1400 platform Standard Features • 7" Multi-color touch screen (loading and unloading side) • Sterilization temperature range 110°C to 137°C • 5 Operation access levels and up to 99 user accounts • Over 1000 cycles & event data stored in internal memory (HTML • Up to 100 cycle programs (customizable by user) • Cycle simulation (for testing cycles) • Easy file transfer via USB or LAN • Thermal serial printer • Ethernet connection for remote monitoring,...

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Pharmaceutical Autoclaves for Pharmaceutical Production-11

Pharma Line Pharmaceutical Autoclaves for Pharmaceutical Production Standard Optional Standard Printer Paper Chart Recorder Enables external remote access for technical support Remote Control* SCADA Software *For remote control operation with the Tablet option, a WiFi router is required.

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Pharmaceutical Autoclaves for Pharmaceutical Production-12

SCADA SCADA software (optional) allows for monitoring of up to 10 sterilizers from external PC workstations. The software retrieves data, creates graphs, tables and printouts. Data for tens-of-thousands of cycles & events (in HTML format) can be stored. Dashboard Real-time temperature, pressure values and graphical trends. Real-time operation of machine. In/Out Digital and Analog Status A feature for technicians to check each system component separately. Piping Diagram Includes cycle information, parameters, data, and graphical trends.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.