The most reliable process controller. THEMA4. First delivered at the beginning of 2. Thema. 4 is today the most reliable and fastest developing process controller in the industry, period. Thema. 4 is defined as a completely configurable standard product classified by GAMP5 as Category 4 Configured Products and is managing all industrial machines manufactured by Fedegari, guaranteeing a total integration among them. Table of Contents Special Pricing for Emerging Economies Learn More The ISPE Baseline Guide RiskBased Manufacture of Pharmaceutical Products RiskMaPP Second. Buttons-Remote-Key-Japan-314-4MHz-67Chip-For-Toyota-Japan-HongKong-South-East-Asia-font.jpg' alt='Gamp5 Guidelines' title='Gamp5 Guidelines' />This achievement is the logical consequence of almost three decades of painstaking work on process controller combined with infrastructure investments, close collaboration with strategic partners and un compromised values because there is no easy shortcut to durable success. Thema. 4, in fact, is the natural evolution of the previous generation of controllers like Thema. Super. Spectra before that, that were based on custom made hardware. While Thema. 4 has inherited the process management principles of its predecessor, it is absolutely different in terms of hardware components COTS, software architecture, HMI and general and integration functions. With Thema. 4, Fedegari assures the commercial availability of standards components, the integration levels required in modern pharmaceutical plants together with functions and performances to meet quality and safety standards of those production processes for which the application is intended. Aiming to guarantee the highest system reliability, Fedegari has chosen Wind River Vx. Works real time operating system RTOS. Wind River is a world leader in embedded and mobile software. It has been pioneering computing inside embedded devices since 1. The Vx. Works Edition with a set of functional modules allows Fedegaris customers to choose the combination of functions that best fits their specific needs. SP Scientific Reachin Chambers are constructed entirely from Stainless Steel, inside and out. The Safety models have a range of 35C to 70C 2C uniformity throughout. NEW Track Trace Validation Documentation for Cost Effective Easy Integration. Based on the GAMP5 guidelines for validation of InSight Track Trace as an. September 2017, Holiday Inn Chicago OHare, USA Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and. Fedegari adopted  Vx. Works because this commercial RTOS has the ability to manage a wide range of hardware devices and ensure robustness, reliability and versatility meeting the companys critical business requirements. Fl Studio Registration Key For All Setup on this page. In order to meet the most demanding pharmaceutical requirements, great care has been taken in designing Thema. Our people is what makes us successful For details please mouse over any of the pictures. GAMP guidelines. Now, after continuous improvements of software and hardware components, functions and processes, Thema. GAMP5. Several new software versions are released every year that include those developments requested or suggested by our end users. Thats why investing in a sterilizer with a Thema. An extensive team of experts assures that the controller is constantly innovated and manages all new developments in accordance with the end users needs and the adopted GMP standards. Reach In Chambers SP Scientific. Specifications by Model Temperature Controlled Stability Chambers 3. R. Chamber Volume. Liters. Chamber Dimensions. External Dimensions. Temperature range. C to 7. 0CControl Resolution. CUniformity at 3. C 2CHeat up time Amb 3. C7 minutes. Heat up time 1. C 5. 0C2. 2 minutes. Recovery time at 3. C. 2. 5 minutes. No. Max no. of shelves. Shelf area each6 sq ft 0. MElectrical Services. V, 1. Ph, 5. 06. Hz 2. W, 1. 6AShipping Weight. Kg. ICH Stability Chambers Temperature and Humidity Controlled 3. HR,3. 3HA 3. 3HR3. HAChamber Volume. Liters. 33 cu ft 9. Liters. Chamber Dimensions. External Dimensions. Temperature range. C to 7. 0C3. 5C to 7. CControl Resolution. C0. 1CHumidity range. RH2. 0 9. 6 RHControl Resolution. C0. 1CUniformity at 3. C 1C 1CHeat up time Amb 3. Batman Arkham City Logo Font. C7 minutes. 7 minutes. Heat up time 1. C 5. C2. 2 minutes Recovery time at 3. C1. 2. 5 minutes. No. of shelves supplied. Max no. of shelves. Shelf area each6 sq ft 0. M6 sq ft 0. 5 sq MElectrical Services. V, 1. Ph, 5. 06. Hz 2. W, 1. 6A2. V, 1. Ph, 5. Hz 2. 0k. W, 1. 6AShipping Weight. Kg. 1,2. 00 lbs 5. Kg. Stability Chambers Fingerprint Development 3. FCChamber Volume. Liters. Chamber Dimensions. External Dimensions. Temperature range. C to 1. 00CControl Resolution. CHumidity range. 20 9. RHControl Resolution. CUniformity at 3. C 2CHeat up time Amb 3. C7 minutes. Heat up time 1. C 5. 0C2. 2 minutes. Recovery time at 3. C1. 2. 5 minutes. No. of shelves supplied. Max no. of shelves. Shelf area each6 sq ft 0. MElectrical Services. V, 1. Ph, 5. 06. Hz 2. W, 1. 6AShipping Weight. Kg. Stability Chambers Filiform Testing 3. FTChamber Volume. Liters. Chamber Dimensions. External Dimensions. Temperature range. C to 7. 0CControl Resolution. CHumidity range. 20 9. RHControl Resolution. CUniformity at 3. C 2CHeat up time Amb 3. MElectrical Services. V, 1. Ph, 5. 06. Hz 2. W, 1. 6AShipping Weight. Kg. Safety Stability Chambers 3. SC. SP Scientific Reach in Chambers are constructed entirely from Stainless Steel, inside and out. The Safety models have a range of 3. C to 7. 0C  2. C uniformity throughout the chamber. Model SEI 3. 3SC is a high quality Temperature only Aerosol Stability Chamber, built for the testing of products containing or producing aerosols. The SP Scientific Stability Chamber is constructed from 3. Stainless Steel, with the exterior surface painted as extra protection. The interior is unpainted allowing easy cleaning. Each Aerosol Chamber is supplied with 4 solid stainless steel shelves which locate into 4 pilasters, and these serve to hold the shelves rigid and bear the load of the samples being tested. There are 1. 9 available shelf positions to allow high storage if required. The rear wall of the Aerosol Chamber has a blow out panel which is activated if the internal pressure reaches 4 p. Models ICH Stability Chambers Temperature Humidity Controlled 1. HR, 1. 0TR, 1. 0HA SEI 1. HRSEI 1. 0TR  SEI 1. HAChamber Volume. Chamber Dimensions. External Dimensions. Temperature range C to 6. C 2. 5C to 6. C. Control Resolution. Humidity Range. Control Resolution. No. of shelves supplied. Max no. of shelves. Shelf area each. M. M. 4 sq ft 0. 3. M. Electrical Services. V, 1. Ph, 6. 0Hz. V, 1. Ph, 6. 0Hz. V, 1. Ph, 6. 0Hz. Shipping Weight. 7. Kg. 7. 50 lbs 3. Kg. Kg. Typical Performance Envelope for a Temperature and Humidity Controlled reach in Chamber SEI 1. HR. Chamber Construction. Stability Environments Reach in Chambers are constructed using Stainless Steel inside and outside. The exterior is painted to blend in with other Laboratory equipment, and to offer increased protection even in the harshest environments. The interior is 3. Stainless Steel incorporating Stainless Steel pylasters making 1. Stainless Steel shelves are supplied as standard. A rear wall Stainless Steel plenum is an essential component of our Stability PLUS airflow system which ensures optimum airflow to achieve the exacting parameter control required by users of these high quality enclosures. Rear Wall Plenum Design. FEATURES2 thick glass fiber insulation. Painted Stainless Steel exterior. Stainless Steel interior with 4 shelves. Antimicrobial coatings available. Choice of door positioning and opening. Wide range of accessories available. Stability PLUS Airflow.